Recruiting
Early Phase 1

Photobiomodulation

Sponsor:

Boston VA Research Institute, Inc.

Code:

NCT04230577

Conditions

Traumatic Brain Injury

Closed Head Injury

Cognitive Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Real LED Intervention

Sham LED Intervention

Study Details

Brief summary:

The purpose of this small, research study is to examine effectiveness of an at-home application of an experimental intervention, on thinking and memory in mild-moderate, closed-head, traumatic brain injury cases. The experimental intervention is light-emitting diode (LED) therapy, which is applied to the scalp and through the nose using a head frame device. Participants are expected to complete two, 5-week series of LED treatments, at home, 3 times a week. There will be a 1-month period between the two series. Each home treatment is 20 minutes. Participants will be trained to use the head frame device, in-office. The head frame device falls within the FDA category General Wellness, low-risk devices, and no medical claims are made. A two-hour paper and pencil testing (4 visits) and a one-hour MRI (3 visits) will be administered before and after each treatment series. Participants may be in the study for about 4 months. This study is supported by Vielight, Inc., Hayward, CA/ Toronto, Canada

Conditions

Traumatic Brain Injury

Closed Head Injury

Cognitive Dysfunction

Study ID

NCT04230577

Start date

Aug 7, 2019

Status verified date

Feb, 2022

Completion date

Sep 30, 2023

Anticipated

Primary completion date

Mar 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18-65 years old
  • Must have had one (or more) closed-head, traumatic brain injuries
  • Loss of consciousness 24 hours or less; or no loss of consciousness/ A period of altered mental status (post-traumatic amnesia)/mental confusion for 24 hours or less
  • Must be able to come to VA Boston Healthcare System, Jamaica Plain Campus for testing visits and Boston University Center for Biomedical Imaging, Boston University School of Medicine for MRI scans

Must meet the following Screening requirements:

  • Participants must score at least 2 SD below normal on at least 1 of the NP tests; or 1 SD below on at least 2 of these NP tests administer at Entry testing: Trail Making Test A \& B; Controlled Oral Word Association Test (COWAT/FAS); California Verbal Learning Test II; DKEFS Color-Word Interference Test (Stroop).

Exclusion Criteria:

  • Diagnosis of a neurological disease such amyotrophic lateral sclerosis (ALS), Parkinson's, Alzheimer's disease
  • History of craniotomy or craniectomy
  • A current life-threatening disease such as cancer
  • Disease requiring organ transplant
  • A severe mental disorder such as schizophrenia, bipolar disorder (not associated with clinically diagnosed PTSD)
  • Current substance abuse or active treatment; within the last 6 months
  • The Test of Memory Malingering is administered at screening; Participants must not have scores that indicate evidence of malingering, a score of less than 45 on either Part 1 or 2 would show evidence of malingering, with the following exception: If a participant fails Trial 1, but does not fail Trial 2, he/she would not be excluded if he/she also show evidence of poor learning on other NP Screening tests, such as the CVLT. If he/she fails Trial 2, alone, or Trial 1 and Trial 2, then this would exclude the participant from the study.
  • Self-reported pain questionnaires (VAS Pain Rating and the Short Form McGill Pain Questionnaire) are also administered. Participants may not have a level of pain greater than 7/10 on VAS or 38/50 on the McGill pain questionnaires at the time of screening.

Exclusion for Magnetic Resonance Imaging Only

  • A BU MRI safety screening form will be reviewed at the time of study screening, as well as at each MRI scan appointment to ensure the participant can safely have an MRI. Participants must tell the investigator about any operations and any metal in his/her body, so it can be decided if it is safe for you to proceed with the scan.

Participants cannot have a MRI scan:

  • if pregnant.
  • if he/she has pacemakers, ear implants, shrapnel injuries, or other types of metal or electric device in their body

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Real LED 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.

sham comparator: Sham LED Intervention

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.

Interventions

Real LED Intervention

A series of Real at-home, transcranial LED treatments (3xWeek, 5 weeks), 20-minute treatment, 810nm (NIR), Vielight Neuro Alpha Head Frame Device (with NIR intranasal).

Sham LED Intervention

A series of Sham at-home, transcranial LED treatments (3xWeek, 5 weeks), 20-minute treatment, Vielight Neuro Alpha Head Frame Device (with intranasal) with Sham LEDs that emit no photons. Sham and Real Devices look and feel identical.

Primary outcome measure

  • CVLT-II, Long Delay Free Recall 1 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 1 ]
  • CVLT-II, Long Delay Free Recall 2 [ Time Frame: Change from Pre-Treatment Baseline to 1-Month after Series 1 ]
  • CVLT-II, Long Delay Free Recall 3 [ Time Frame: Change from 1-Week to 1-Month after Series 1 ]
  • CVLT-II, Long Delay Free Recall 4 [ Time Frame: Change from Pre-Treatment Baseline to 1-Week after Series 2 ]

Central Contacts and Locations

Central contacts

Paula I Martin, PhD

857-364-4029Paula.Martin@va.gov

Michael Ho, PhD

857-364-2213Michael.Ho3@va.gov

Locations

VA Boston Healthcare System

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

Paula I Martin, PhD

857-364-2631paulak@bu.edu

Margaret Naeser, PhD

857-364-4030mnaeser@bu.edu

More Information

Sponsor

Boston VA Research Institute, Inc.

Last update posted

Feb 25, 2022

Last verified

Feb, 2022

Keywords

  • mild-moderate traumatic brain injury
  • TBI
  • Cognition
  • Executive Function
  • Attention
  • Memory
  • Photobiomodulation (PBM)
  • Low-level Laser Therapy (LLLT)
  • Light-Emitting Diodes (LEDs)
  • Magnetic Resonance Imaging (MRI)
  • functional MRI (fMRI)
  • resting-state functional connectivity MRI (rs-fcMRI)
  • Magnetic Resonance Spectroscopy (MRS)
  • Post Traumatic Stress Disorder (PTSD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston VA Research Institute, Inc. on 2022-02-25.