Independent Research (utilizing Vielight technology)
- Photobiomodulation for Improving Brain Function in Dementia (PBM Dementia)
University of California, San Fransisco
[ Study Link (clinicaltrials.gov, U.S. National Institutes of Health) ]
Vielight Research [Ongoing]
(2017 Winter) Vielight Neuro RX Gamma – Feasibility Pilot
Direct access to information on pilot study on clinicaltrials.gov – [ Study Link (clinicaltrials.gov, U.S. National Institutes of Health) ]
An IRB-approved pilot study evaluating the feasibility, safety, and efficacy of the Vielight Neuro Gamma for the treatment of moderate-to-severe Alzheimer’s Disease.
- Trial Registration
Click here for more information – Link.
Double-blind, sham-controlled, prospective, multi-site, RCT (1:1 ratio)
- Study Duration
- Study Site(s)
Community-based sites (up to 5)
- Number of Study Subjects
- Diagnosis and Main Inclusion Criteria
Individuals who meet the criteria for probable Alzheimer’s disease of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) as well as the following:
• 50 years of age or older
• Outpatient with a reliable caregiver committed to study visits
• Mini Mental State Examination score between 8-20
• No current major psychiatric or other neurologic disease
• No history of stroke or seizures
NOTE: A complete list of participating investigators will be maintained and will be available upon request.
10.1 Investigator Responsibilities
The Investigator(s) shall be responsible for the day-to-day conduct of the investigation as well as for ensuring that the investigation is conducted according to all signed agreements, applicable elements of ISO 14155, the Clinical Investigational Plan, applicable Health Canada regulations, the principles that have their origin in the Declaration of Helsinki, and any conditions of approval imposed by the REB/EC or Health Canada. The investigator is also responsible for protecting the rights, safety and welfare of subject’s under the investigator’s care and for obtaining informed consent in accordance with Canada’s Medical Device Regulations Part 3(81)(k) and FDA’s regulations 21 CFR Part 50 Protection of Human Subjects and 21 CFR Part 812 Investigational Device Exemptions. Each Investigator must sign the Investigator Agreement and Financial Disclosure prior to subject enrolment. No investigator will be added to the investigation until a signed Investigator Agreement is provided.
Responsibilities of the Investigator include, but are not limited to:
1. Submit proposed amendments to the protocol and informed consent to the REB and await approval, unless the change reduces the risk to subjects.
2. Ensuring that all personnel assisting with the clinical trial are adequately informed and understand their trial-related duties and functions
3. Obtain informed consents of subjects.
4. Permit monitor to inspect facilities and records.
5. Maintain medical histories of subjects.
6. Enroll subjects, execute the study, transcribe data from source documents to case report forms, and conduct study in accordance with protocol.
7. Submit annual progress reports, final reports, and Adverse Event reports to the IRB and to Sponsor.
8. Notify the local or national authority and the manufacturer (Vielight Inc.) within 72 hours of any incident that meets the criteria as defined in Subsection 59(1) of the Medical Devices Regulations. [Subsection Subsection 59(1) defines two types of device related incidents. The first is related to a failure or deterioration in the effectiveness of the device or any inadequacy in its labelling or in the directions for use accompanying it. The second involves an incident that has led to the death or a serious deterioration in the health of a subject, user or other person or, where it is reasonable to believe that such an incident were it to recur, could lead to the death or a serious deterioration of the state of health of a subject, user or other person.
9. Disclose to Vielight Inc. sufficient accurate financial information to allow them to submit completed and accurate certification and disclosure statements under US 21 CFR54. The investigator shall promptly update this information if any relevant changes occur during the course of the investigation and for 1 year following completion of the study
The Investigator will allow direct access to source data/documents for trial related monitoring, audit, IRB review and regulatory inspection. Also, the investigator will allow auditing of their clinical investigational procedure(s).
10.2 Required Documents from the Investigator
At a minimum, the following documents will be provided by the investigational site to the study sponsor:
• Signed Investigator Agreement
• Current Curriculum Vitae
• Completed and accurate certification and disclosure statements under US 21 CFR54
• Any other relevant documents requested by the study sponsor, IRB or other regulatory authority
A site may not begin study participation until all of the above listed documents have been provided to the study sponsor.
10.2.1 Investigator Records
The Investigator is responsible for maintaining medical and study records for every subject participating in the clinical study (including information maintained electronically such as digital imaging). The Investigator will also maintain original source documents from which study-related data are derived, which include, but are not limited to:
• all correspondence including required reports with another investigator, an IRB, the sponsor, a monitor, FDA or any other competent authority.
• records of each subject’s case history and exposure to the device which must include,
• signed and dated consent forms
• condition of each subject upon entering the study
• relevant previous medical history
• observations of relevant adverse device effects (anticipated or unanticipated)
• adverse events reporting and follow-up of the adverse events
• medical records (physician and nurse progress notes, hospital charts, etc.)
• results of all laboratory tests
• notations on abnormal lab results
• case report forms
• subjects condition upon completion of or withdrawal from the study
• any other supporting data
• the protocol and documentation (date and reason) for each deviation from the protocol.
• any other records that Health Canada, FDA or other regulatory body requires to be maintained by regulation or by specific requirement for a category of investigation or a particular investigation.
The Investigator must ensure that all subject records are stored for at least 2 years after the end of the clinical study or the records are no longer required to support a regulatory approval, whichever date is later. To avoid error, the study site should contact Vielight Inc. prior to the destruction of study records to ensure that they no longer need to be retained. In addition, Vielight Inc. should be contacted if the Investigator plans to leave the investigational site so that arrangements can be made for the handling or transfer of study records.
10.3 Sponsor Responsibilities
Vielight Inc. is the Sponsor of this study. Vielight Inc.’s responsibilities include but are not limited to:
1. Selecting qualified investigators (qualifications will be documented by curriculum vitae )
2. Providing investigators with the information necessary to conduct the investigation properly
3. Providing appropriate training to each study site and all study personnel (monitors), as necessary
4. Documenting training where appropriate
5. Selecting monitors qualified by training and experience to monitor the investigational study in accordance with FDA and Health Canada regulations or train monitors if necessary.
6. Ensuring that the IRB approval is obtained
7. Ensuring that any reviewing IRB or regulatory authority are informed of significant new information
8. Providing the devices to qualified investigators
9. Report and investigate unanticipated, device related Adverse Events
10. Obtaining signed Investigator Agreement for each investigator prior to their participation in the study
11. Obtaining sufficient and accurate financial disclosure information
12. Reporting per local regulations
13. Retain records for at least 3 years following completion of this study.
10.3.1 Sponsor Records
The Sponsor shall maintain the following accurate, complete and current records relating to the investigation:
• All correspondence including required reports
• Signed investigator’s agreements including financial disclosure information
• Records concerning adverse device effects and complaints
10.4 Study Monitoring Plan
The study will be monitored to ensure that applicable regulations are followed. Written procedures will be established in a monitor plan to ensure the quality of the study and to ensure that each person involved in the monitoring process carries out the required duties. The sponsors shall designate or assign monitors to this clinical study.
Each site will be visited regularly in an effort to ensure that the study is conducted in compliance with the Clinical Investigational Plan and all applicable guidelines, laws and regulations.
Prior to subject enrollment, a study initiation visit will be completed at each investigational site to ensure the following: IRB approval has been obtained and documented; the Investigators and study personnel are appropriately trained and clearly understand the study; and the Investigators and study personnel accept the obligations incurred in undertaking this clinical investigation.
Periodic monitoring visits will be made at all active study sites throughout the clinical study to assure that the Investigator obligations are fulfilled and all applicable regulations and guidelines are followed. These visits will assure that the facilities are still acceptable; the protocol, investigational and monitoring plan are being followed, the IRB has been notified of approved protocol changes as required, complete records are being maintained, appropriate and timely reports have been made to the Sponsor and the IRB, device and device inventory are controlled and the Investigator is carrying out all agreed activities.
Typically, source-document verification of CRFs will be done shortly after the CRFs are completed. Mutual agreement will take place between all parties to ensure that the forms are monitored in a timely manner. A study termination visit will be conducted at the completion of the clinical investigation to ensure that all subject data are properly documented and that all clinical materials are returned to the Sponsor.
CRF findings of non-compliance or required modifications shall be reviewed with the Investigator(s) and disclosed in a written monitoring report. The monitor will report to the sponsor any non-compliance with the signed Investigator’s Agreement, conditions imposed by the IRB or regulatory authorities. The sponsor shall then either secure compliance, or terminate the investigator’s participation in the investigation (Section 85(2)(b) of the Medical Device Regulations).
A complete list of study monitors and their qualifications will be maintained and will be available upon request.
10.5 Ethical Considerations
The rights, safety and well-being of clinical investigation subjects shall be protected consistent with the ethical principles laid down in the Declaration of Helsinki. This shall be understood, observed and applied at every step in this clinical investigation.
It is expected that all parties will share in the responsibility for ethical conduct in accordance with their respective roles in the investigation. The Sponsor and the Investigator(s) shall avoid improper influence or inducement of the subject, monitor, the clinical investigator(s) or other parties participating in or contributing to the clinical investigation.
10.5.1 Protection of Subject Confidentiality
At all times throughout the clinical investigation, confidentiality will be observed by all parties involved. All data shall be secured against unauthorized access. Privacy and confidentiality of information about each subject shall be preserved in study reports and in any publication. Each subject participating in this study will be assigned a unique identifier. All CRFs will be tracked, evaluated, and stored using only this unique identifier.
The Investigator will maintain a confidential subject list identifying all enrolled subjects (Enrollment Log). This list will contain the assigned subject’s unique identifier and name. The Investigator bears responsibility for keeping this list confidential. This list will not be provided to the study sponsor and is only to be used at the study center.
Monitors and auditors will have access to the subject list and other personally identifying information of subjects to ensure that data reported in the CRF corresponds to the person who signed the ICF and the information contained in the original source documents. Such personal identifying information may include, but is not limited to the subject or caregiver’s name, address, date of birth, gender, race and medical record number.
Any source documents copied for monitoring purposes by the Sponsor will be identified by using the assigned subject’s unique identifier in an effort to protect subject confidentiality.
10.5.2 Ethics Committee/Institutional Review Board Approval
Institutional Review Board (IRB) / Research Ethics Board (REB) approval is required prior to study commencement. The Investigator must also work with sponsor personnel to obtain renewal of IRB/REB approval as dictated by local requirements during the entire duration of the study. The Investigator is responsible for fulfilling any conditions of approval imposed by the reviewing IRB/REB, such as regular reporting, study timing, etc. The Investigator will provide the study sponsor with copies of such reports.
10.5.3 Quality Assurance and Supervision by Authorities and Privacy
All documents and data shall be produced and maintained in such a way to assure control of documents and data to protect the subject’s privacy as far as reasonably practicable. The Sponsor and representatives of the regulatory authorities are permitted to inspect the study documents (e.g., study protocol, CRFs, and original study-relevant medical records/files) as needed. All attempts will be made to preserve subject confidentiality.
All clinical sites are subject to audit by study sponsor personnel or designee for protocol adherence, accuracy of CRFs and compliance with applicable regulations. Any evident pattern of non-compliance with respect to these standards will be cause for the site to be put on probation until appropriate corrective action is taken.
10.6 Final Report
A final report will be completed, even if the study is prematurely terminated. At the conclusion of the trial, an abstract reporting the results will be prepared and will be presented at a major meeting(s). A manuscript will also be prepared for publication in a reputable scientific journal.
10.7 Information Confidentiality
All information not previously published concerning the test device and research, including patent applications, manufacturing processes, basic scientific data, etc., is considered confidential and should remain the sole property of Vielight Inc. All information and data generated in association with this study will be held in strict confidence and remain the sole property of Vielight Inc. The Investigator agrees to use this information for the sole purpose of completing this study and for no other purpose without written consent from Vielight Inc.
10.8 Trial Registration
The study will be registered in a publicly accessible trial database (clinicaltrials.gov) prior to study initiation.
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- Study Sponsor
CEO, Vielight Inc.
346A Jarvis Street
- Principal Investigator
(2018 Spring) Vielight Neuro Gamma Photobiomodulation Device for Moderate to Severe Alzheimer’s Disease
- Principal Investigator
Dr. Corinne E. Fischer, MD
Director of Memory Disorders Clinic, Geriatric Psychiatry, and Geriatric Mental Health Outreach Program, St. Michael’s Hospital
Adjunct Scientist in the Keenan Research Centre of the Li Ka Shing Knowledge Institute of St. Michael’s Hospital
- Regulatory and Funding Sponsor
346A Jarvis Street Toronto, Ontario M4Y 2G6
Lew Lim, Founder and CEO, firstname.lastname@example.org
- Methodology Centre
Applied Health Research Centre
The Hub, Li Ka Shing Knowledge Institute St. Michael’s Hospital
30 Bond Street Toronto, ON, M5B 1W8
Stephanie De Masi, email@example.com
The following assessments will be performed during clinic visits at baseline, 12 and 24 weeks and during an extended follow up visit at 52 weeks:
• Severe Impairment Battery (SIB)
• Alzheimer’s Disease Cooperative Study Activities of Daily Living for Severe Alzheimer’s Disease (ADCS-ADL-Sev) scale
• Quality of life using European Quality of Life–5 Dimensions (EQ-5D, proxy version) and the Quality of Life in Alzheimer’s Disease (QOL-AD) scale
• Adverse events (AEs) and serious adverse events (SAEs)
• Resource Utilization in Dementia (RUD) instrument
• Neuropsychiatric Inventory Questionnaire (including Caregiver Distress ratings) at weeks 12, 24 and 52
The AHRC will work closely with the study Investigator(s) to manage this clinical trial, including site selection and site management, study training, study documentation, and project communications. AHRC will coordinate data management activities and will be responsible for developing electronic case report forms (eCRFs), performing data validation activities, providing data outputs and performing statistical analyses.
The AHRC employs industry-leading web-based secure database technology (REDCap and Medidata RAVE™) which incorporate advanced data validation and reporting tools, and allow for faster access to trial data than traditional paper-based data collection tools. Our electronic databases have built-in web-based study randomization tools, and can link with other data systems (e.g. laboratory information systems) to facilitate automatic upload of clinical data to minimize manual entry. The AHRC is using electronic data capture software to manage data for over 30 studies, including more than 20 CIHR-funded multi-centre trials.
Vielight Research [Completed]
(2015) Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report
- Study Sponsor
CEO, Vielight Inc.
346A Jarvis Street
- Principal Investigator
Anita E. Saltmarche, RN, MHSc
Saltmarche Health & Associates
Margaret A. Naeser, PhD
Neuroscientist – Boston University School of Medicine, Veterans Affairs of America
Michael R Hamblin, PhD
Research Scientist – Harvard Medical School, Wellman Center for Photomedicine
Kai Fai Ho, PhD
(2017) Evaluating the effect of the Vielight Neuro Gamma Device on real-time EEG signals in older adults at rest. (March – April 2017)
- Study Title
Evaluating the effect of the Vielight Neuro Gamma Device on real-time EEG signals in older adults at rest.
- Study Objective
To evaluate whether the energy delivered by the Vielight Neuro Gamma produces a reliable effect on neural activity in older adults.
Double-blind, prospective, crossover.
- Study Duration
Two session evaluation.
- Study Site(s)
Vielight Inc. Office
- Number of Subjects
Maximum of 20 older adults
- Major Inclusion/Exclusion Criteria
• 60 years of age or older
• No current major psychiatric or neurologic disease
• No history of stroke or seizures
• All other medical conditions controlled by stable therapy
- Study Product and Planned Use
The experimental intervention will be the Vielight Neuro Gamma general wellness device. The device uses 5 light emitting diodes (810nm wavelength). Four diodes provide near-infrared energy transcranially, while the last does so intranasally, all targeting regions of the Default Mode Network. No significant heat is generated, allowing for a sham device which will be indistinguishable from the intervention to both the subjects and EEG technician. Devices will be utilized concurrently with EEG recording of subject at rest. The devices will be used in a randomized crossover design within the single study visit with the same EEG recordings to be obtained under both sham and active conditions.
- Study Procedures
1. Informed Consent
2. Eligibility Assessment
3. First EEG Recording
4. One week washout period
5. Second EEG Recording
- Primary Endpoint
Change from baseline in overall power spectral density between active and sham session.
- Statistical Methodology
Repeated measures ANOVA with treatment as within subject measure.
- 2.1. Study Rationale & Background
Vielight Inc. has developed a novel general wellness device, called the Vielight Neuro Gamma, which delivers near infrared light through LEDs positioned over the skull and intranasally. This device is intended to enhance mental acuity as a general wellness device.
There are questions as to whether near infrared light is capable of penetrating the skull and/or nasal mucosa to reach and produce reliable effects in the brain.
Thus, Vielight Inc. wishes to utilize electroencephalography (EEG) as a method to measure, in real time, the effects of the Vielight Neuro Gamma on neural activity.
- 2.2. Study Device: Vielight Neuro Gamma
The Vielight Neuro Gamma device is a portable, wearable, low-level light delivery device that administers near-infrared light to the brain trans-cranially and intra-nasally and is intended to enhance mental acuity as part of general wellness. The device, shown below, consists of a controller (1), a Nasal Applicator (2), and a Head Set (3).
LEDs is placed inside the nose for intranasal transmission of light energy and the remaining four LEDs are positioned over the skull for transcranial transmission.
- 2.3. Study Objective
In order to effectively test the capability of the Vielight Neuro Gamma to affect neural activity, EEGs using an active device must be compared to sham device EEGs in 20 subjects. This will allow us to reasonably calculate whether there is a significant difference in power spectral density as well as examine other relevant outcomes post-hoc.
- 2.4. Study Design
This is a non-randomized prospective experimental study.
Study Procedures are as follows:
1. Informed Consent
2. Eligibility Assessment
3. First EEG Recording
4. One week washout period
5. Second EEG Recording
- 2.5. Study Endpoints
Detailed information about endpoint calculation is provided in Section 6 Statistical Plan and Methods.
- 2.6. Study Site
This study will be conducted in the offices of Vielight Inc. at 346A Jarvis Street in the downtown Toronto region. This site has been setup to meet the requirements of the EEG system.
- 3.1. Inclusion Criteria
1. Present valid government identification demonstrating age of 60 years or older
2. Capable of speaking English in order to comply with study procedures
3. Capable of reading English in order to complete Informed Consent form and online screening survey
- 3.2. Exclusion Criteria
1. Unable/unwilling to sign Informed Consent form
2. Mini Mental State Examination (MMSE) score of <27
3. Current major psychiatric or neurologic disease
4. History of stroke or seizures
5. Medical conditions uncontrolled by stable therapy
- 4.1. Subject Recruitment
Subjects will be recruited from the Greater Toronto Area through recruitment advertisements placed online on sites such as Craigslist or Kijiji and via social media sites including Facebook. Advertisements in the form of posters in the local area surrounding the study site or in newspapers such as NOW! or Eye Weekly may also be used to recruit prospective subjects. Any advertisements will be approved by an Institutional Review Board. A total of 20 subjects are anticipated to complete this study.
- 4.2. Preliminary Eligibility Assessment
Eligibility screening will be conducted through an online screening form providing a short description of the study and requesting non-medical information. Questions will be related to the inclusion criteria in section 3 above as well as with regards to their ability to comply with study procedures (eg. willingness to remove any religious clothing or wigs to accommodate the EEG cap).
- 4.3. Study Visit Procedures
FIRST STUDY VISIT
A) Study description and Informed Consent
• Study staff will explain the purpose of the study to the participant and what study participation will involve.
• Information must be given in both oral and written form.
• Subjects will be provided a copy of the Informed Consent Form, and given as much time as necessary to make an informed decision regarding participation.
• The subject information advises the participant that they are free to refuse their participation in or withdraw from the study at any time.
• The subject will be encouraged to ask questions.
• The investigator or other study staff will then obtain and document informed consent from the participant.
• The subject will be given copies of the signed Informed Consent Form.
• If consent is declined, the subject’s reason for declining (if provided) will be recorded in the screening log and CRF
B) Assessment of eligibility criteria
• Following consent, study staff will reassess eligibility captured during online screening and record these on the study Case Report Form (CRF).
• Study staff will also confirm the following exclusion criteria and record these on the study Case Report Form (CRF):
a. No current major psychiatric disorder or neurologic disease
b. No history of stroke or seizure
c. No other medical conditions uncontrolled by stable therapy
• Study staff will then conduct the MMSE to determine if the participants score is above 27 (ie. cognitively healthy) and record this on the study Case Report Form (CRF).
• INCIDENTAL FINDINGS: If the subject has a MMSE score of 23 or lower, they will be informed that their score indicates potential cognitive impairment; however, this finding may be erroneous. Subjects will be encouraged to visit a physician in order to be properly assessed for cognitive impairment.
• If the subject does not satisfy eligibility criteria, the subject will not be enrolled and the CRF will indicate the reason for exclusion. A screening log will be maintained listing all subjects screened for the study and will document the reasons for non-participation of non-enrolled subjects.
C) Acquisition of EEG recordings
• Subject will be asked to sit in a comfortable chair, with their back supported and their legs and ankles uncrossed with feet flat on the floor
• Study staff will record any relevant subject details (physical characteristics and demographics) in the Case Report Form. These include but are not limited to: the Subject’s date of birth (YYYY-MM-DD), sex, weight, height, etc.
• Study staff will place the saline-rinsed EEG electrode cap on the subject and may apply additional saline to individual electrode locations in order to ensure good conductivity
• Once the electrode cap is producing reliable readings, the subject will be asked to remain still and quiet with their eyes closed for an initial 10 min Rest-EEG recording
• At the completion of the 10 min recording, study staff will then place the Vielight Neuro Gamma device or Sham device on the subject, as shown in Figure 2 above.
• Study staff may then re-apply additional saline to individual electrode locations in order to ensure good conductivity
• Once the electrode cap is producing reliable readings, the subject will be asked again to remain still and quiet with their eyes closed for a 20 min Rest-EEG recording
• At the completion of the 20 min recording, study staff will then remove the Vielight Neuro Gamma device or Sham device and again re-apply additional saline to individual electrode locations in order to ensure good conductivity
• Once the electrode cap is producing reliable readings, the subject will be asked to remain still and quiet with their eyes closed for a final 10 min Rest-EEG recording
SECOND STUDY VISIT
The second study visit will be a replication of Part C of the first visit. At the conclusion of the visit, the subject will be provided financial compensation of $100 CAD for the study.
- 5.1. Devices and Procedural Purposes
Device(s) being evaluated for effect on neural activity
Vielight Neuro Gamma
Quantitative EEG system with recording electrode cap
BrainMaster Discovery 20 System
- 5.2. Device Safety
Vielight Neuro Gamma: The controller houses three 1.5V NiMH batteries (1900 mAh each) and the controlling electronics for the Neuro Gamma. Both the Headset and Nasal Applicator are connected to the controller with connectors that prevent them from being incorrectly inserted. A single button initiates a software controlled 20-minute therapy – automatically timed but can be discontinued by pressing the button a second time. The maximum power output density to the nasal mucosa is 25 mW/cm2 with a 50% duty cycle (total energy delivered per session = 15 J). The maximum power output density to the scalp is 100 mW/cm2 with a 50% duty cycle for the posterior band LEDs and 100 mW/cm2 with a 50% duty cycle for the anterior band LED (total energy delivered per session = 225 J). All LEDs are well under the exposure limits established by IEC 62471:2006 – Photobiological safety of lamps and lamp systems..
BrainMaster Discovery 20 System: The BrainMaster Device does not produce any electro-magnetic fields and does not interfere with the operability of other devices The unit is entirely powered by the USB interface, eliminating the need for batteries, while maintaining subject safety.
- 6.1. Planned Analysis
The primary endpoint for this study will be the change from baseline in overall power spectral density between active and sham session. To statistically determine a significant difference a repeated measures ANOVA with treatment as the within-subject measure will be utilized.
Additional exploratory analysis of a variety of measures obtained from the EEG recording will be conducted post-hoc.
- 6.2. Primary Endpoint Analysis: Sample Size Selection
The sample size of the study was chosen based on a review of the literature for exploratory EEG studies of novel neurotechnologies. Utilizing a sample size of 20 for this initial study will allow us to best estimate effects sizes of critical measures to be examined in follow-up confirmatory studies.
- 6.3. Eligibility of Subjects, Exclusions, Missing Data, and Removal of Subjects
All subjects responding to the advertisements are potential study candidates and will be screened for eligibility. Every effort will be made to ensure eligibility of the subjects prior to study enrollment. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled or followed in the study. Subjects for whom no data was acquired due to technical failures or those that withdraw consent will be excluded from analysis. Subjects for whom only partial data was acquired will be included in all possible analysis.
- 7.1. Serious Adverse Events
A serious adverse event is any adverse event which occurs during the study visiti. is life threatening; orii. results in permanent impairment of a body function or permanent damage to a body structure; oriii. necessitates significant intervention, such as major surgery, to prevent permanent impairment of a body function or permanent damage to a body structure; oriv. requires hospitalization or an extended hospital stay; orv. results in moderate transient impairment of a body function or transient damage to a body structure; orvi. requires intervention, such as medication or cardioversion to prevent permanent impairment of a body function or damage to a body structure.Examples of serious adverse events include death, cardiac tamponade, myocardial infarction, stroke, and seizure.
- 7.2. Adverse Events
An adverse event is any adverse event that results in minimal transient impairment of a body function or damage to a body structure or which does not require any intervention other than monitoring. Examples of an adverse event include skin reaction or headache at the locations where the Vielight Neuro Gamma device makes contact with the subject’s skin.
A pre-existing condition should not be reported as an adverse event unless there has been a substantial change in severity that cannot be attributed to natural history.
- 7.3. Reporting
As this is a minimal-risk study, no serious adverse events are anticipated. However, any adverse events reported by subjects or observed by the study staff, during the course of the study visit procedures, will be recorded in the subjects CRF along with a brief description and any action taken. All adverse events determined by the principal investigator to be a potential result of study visit procedures, will be reported to the Institutional Review Board and the study sponsor.
- 8.1. Anticipated Study Timeline
• Recruitment Initiation
• 20 Subjects Recruited
D0 + 4 weeks
• Interim Analysis Completed
D0 + 4 weeks +10 days
• Study Complete
D0 + 6 weeks
- 8.2. Criteria for the Termination of the Trial
The study will be terminated upon completion of the recruitment target (N=20) and verification of the data by the study sponsor. The study may also be terminated earlier at the discretion of the sponsor.
- 8.3. Essential Documentation
The Principal Investigator and other appropriate study personnel will sign the protocol to document their willingness to adhere to this protocol and to conduct the study in accordance with local legal requirements and the International Conference on Harmonization (ICH) guidelines for GCP.
In order to be authorized to initiate the study, the Principal Investigator will ensure the following documentation is obtained:
1. A copy of the dated, documented approval of the IRB to the protocol and any amendments, subject consent forms, advertisements for subject recruitment , subject compensation, and any other documents submitted. The IRB approval should quote version numbers and/or dates of documents reviewed
2. Evidence that the IRB operated in compliance with 21CFR56 (e.g., list of members and affiliations)
3. The Principal Investigator’s current curriculum vitae (CV)
4. A copy of the protocol signed with a statement of interest by the Principal Investigator
All other relevant documents essential prior to study initiation should be placed appropriately in the site’s study master files.
- 8.4. Subject Confidentiality
The confidentiality of subjects enrolled in this study will be maintained at all times.
All study reports and communications relating to subjects will identify each subject by their subject number and initials only. Investigators will maintain a log enabling them to identify clearly each subject enrolled.
- 8.5. Quality Control, Quality Assurance, Monitoring
The data from source documents will be entered into CRFs. The data will be subjected to manual review for completeness, logic, accuracy, and consistency. A final monitoring report will be generated demonstrating compliance to the protocol.
- 8.6. Data Integrity
Data integrity is ensured through monitoring by the sponsor of source document to CRF verification.
- 8.7. Data Handling and Record Keeping
8.8.1. Study Finance
Subjects will be provided $100 CAD as compensation for their involvement at the end of the second study visit, following the completion of all study procedures.
8.8.2. Financial Disclosure/u>
The investigator must provide the sponsor with sufficient and accurate financial information to meet regulatory disclosure requirements (21 CFR 54). The investigator will update this information if any relevant changes occur during the investigation and for one year following the completion of the study.
- 8.9. Publication Policy
All information concerning the sponsor’s operations, such as patent applications, formulae, manufacturing, processes, scientific data, or information supplied to the investigator by the sponsor and not previously published is considered confidential and shall remain the sole property of the sponsor. The investigator agrees to use this information only in accomplishing the study and will not use it for other purposes, without the prior written consent of the sponsor.
- Study Sponsor
CEO, Vielight Inc.
346A Jarvis Street
- Principal Investigator
Reza Zomorrodi, PhD
Research Advisor, Vielight
Genane Loheswaran, MSc
Research Advisor, Vielight
Janine Liburd, PhD
Research Scientist, Vielight
Abhiram Pushparaj, PhD
Regulatory Consultant, IPD
Main Office: 346A Jarvis Street, Toronto, ON M4Y 2G6
Toll Free(North America): 1-855-339-6107
Email : firstname.lastname@example.org