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Photobiomodulation

Real LED Intervention for Traumatic Brain Injury

Q: What is the capacity of participants for this clinical trial?

Affirmative, based on the information provided by clinicaltrials.gov, this experiment is presently recruiting study participants. It was initially posted on August 7th 2019 and most recently modified February 24th 2022. There are 20 openings at a single medical centre.

Q: Is the age eligibility for this clinical investigation limited to those over 25 years old?

As indicated by the requirements of this trial, potential participants must fall between 18 and 65 years old.

Q: Who can submit an application to participate in this experiment?

To partake in this clinical trial, participants must present with cognitive impairment and be within the accepted age range of 18 to 65. The study is open for a maximum of 20 enrollees.

Q: Are any members of the public eligible to join this research investigation?

Clinicaltrials.gov suggests this trial is still looking for participants, as the listing was most recently updated on February 24th 2022 - having initially been posted to the site on August 7 2019.

Q: What is the ultimate purpose of this medical research?

According to the sponsor, Vielight Inc., their primary outcome measure within this trial is CVLT-II Long Delay Free Recall 4. Secondary outcomes include <a href="https://www.withpower.com/clinical-trials/california">California</a> Verbal Learning Test-II Immediate Free Recall; Short Form McGill <a href="https://www.withpower.com/clinical-trials/pain">Pain</a> Questionnaire 1 and Visual Analog Pain Rating Scale (VAS) 4. <a href="https://www.withpower.com/clinical-trials/all">All</a> of these are being evaluated over a one month period following series 1 treatments with minimum and maximum scores for each assessment noted.

Phase < 1

Waitlist Available

Led By Paula I Martin, PhD

Research Sponsored by Boston VA Research Institute, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from 1-week to 1-month after series

Awards & highlights

Study Summary

This trial is exploring whether an at-home light therapy using a head frame device can help improve thinking and memory in people with mild to moderate traumatic brain injury. The therapy involves using the device for 20 minutes, 3 times a week, for 5 weeks, with a one-month break in between. There will be 4 office visits for paper and pencil testing, and 3 office visits for MRI scans. The trial will last for about 4 months.

Eligible Conditions

Traumatic Brain Injury
Head Injuries
Cognitive Impairment

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from 1-week to 1-month after series

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from 1-week to 1-month after series

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from 1-week to 1-month after series for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CVLT-II, Long Delay Free Recall 1

CVLT-II, Long Delay Free Recall 2

CVLT-II, Long Delay Free Recall 3

+1 more

Secondary outcome measures

Beck Depression Inventory (BDI) 1

Beck Depression Inventory (BDI) 2

Beck Depression Inventory (BDI) 3

+85 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Real LED InterventionActive Control1 Intervention

Participants receive 15 Real (active) LED treatments with the Vielight Neuro Alpha head frame device (with intranasal). Parameters: NIR, 810nm, pulsed at 10 Hz, 50% duty cycle, synchronized for a 20-minute treatment time. Total Energy Dose per head set plus intranasal: 225 J/cm2+ 15 J/cm2 = 240 J/cm2 per 20 min LED treatment. Total Energy Dose delivered (3x/Week, 5 Weeks) = 3600 J/cm2. The light from these LEDs is not visible to the eye. There is no potential for eye damage because the LEDs are not laser light. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. It is approved for use by the VA Boston Healthcare System Safety Committee and Institutional Review Board.

Group II: Sham LED InterventionPlacebo Group2 Interventions

Participants receive a series of 15 Sham (control) LED treatments with the Vielight Neuro Alpha head frame device (with intranasal) containing Sham LEDs, synchronized for a 20-minute treatment time (3x/Week, 5 Weeks). Sham and Real devices are identical in look and feel, except no photons are emitted from the Sham devices.

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Who is running the clinical trial?

Boston VA Research Institute, Inc.Lead Sponsor

22 Previous Clinical Trials

10,786 Total Patients Enrolled

VA Boston Healthcare SystemFED

68 Previous Clinical Trials

970,432 Total Patients Enrolled

Vielight Inc.Industry Sponsor

4 Previous Clinical Trials

619 Total Patients Enrolled

Media Library

Real LED Intervention (Photobiomodulation) Clinical Trial Eligibility Overview. Trial Name: NCT04230577 — Phase < 1

Traumatic Brain Injury Research Study Groups: Real LED Intervention, Sham LED Intervention

Traumatic Brain Injury Clinical Trial 2023: Real LED Intervention Highlights & Side Effects. Trial Name: NCT04230577 — Phase < 1

Real LED Intervention (Photobiomodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04230577 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of participants for this clinical trial?

"Affirmative, based on the information provided by clinicaltrials.gov, this experiment is presently recruiting study participants. It was initially posted on August 7th 2019 and most recently modified February 24th 2022. There are 20 openings at a single medical centre."

Answered by AI

Is the age eligibility for this clinical investigation limited to those over 25 years old?

"As indicated by the requirements of this trial, potential participants must fall between 18 and 65 years old."

Answered by AI

Who can submit an application to participate in this experiment?

"To partake in this clinical trial, participants must present with cognitive impairment and be within the accepted age range of 18 to 65. The study is open for a maximum of 20 enrollees."

Answered by AI

Are any members of the public eligible to join this research investigation?

"Clinicaltrials.gov suggests this trial is still looking for participants, as the listing was most recently updated on February 24th 2022 - having initially been posted to the site on August 7 2019."

Answered by AI

What is the ultimate purpose of this medical research?

"According to the sponsor, Vielight Inc., their primary outcome measure within this trial is CVLT-II Long Delay Free Recall 4. Secondary outcomes include California Verbal Learning Test-II Immediate Free Recall; Short Form McGill Pain Questionnaire 1 and Visual Analog Pain Rating Scale (VAS) 4. All of these are being evaluated over a one month period following series 1 treatments with minimum and maximum scores for each assessment noted."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Photobiomodulation to Improve Cognition in TBI, With fMRI

2019. "Photobiomodulation to Improve Cognition in TBI, With fMRI". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04230577.

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