Photobiomodulation to Improve Cognition in TBI, With fMRI

NCT04230577 | Unknown Early Phase 1

• 2 other identifiers: 0216aVielight3223
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

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)

Outcome Measures

Primary Outcomes (4)

• CVLT-II, Long Delay Free Recall 1

  California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled. Alternate lists are used at each testing timepoint to avoid practice effect

  Change from Pre-Treatment Baseline to 1-Week after Series 1

• CVLT-II, Long Delay Free Recall 2

  California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled. Alternate lists are used at each testing timepoint to avoid practice effect

  Change from Pre-Treatment Baseline to 1-Month after Series 1

• CVLT-II, Long Delay Free Recall 3

  California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled. Alternate lists are used at each testing timepoint to avoid practice effect

  Change from 1-Week to 1-Month after Series 1

• CVLT-II, Long Delay Free Recall 4

  California Verbal Learning Test-II Long Delay (20 mins) Free Recall; Measures Verbal Memory Min score of 0 and a max score of 16; higher score = better outcome. After a 20 minute delay (other tasks run during this delay), participant is asked to recall items from List A. Total is number of words recalled. Alternate lists are used at each testing timepoint to avoid practice effect

  Change from Pre-Treatment Baseline to 1-Week after Series 2

Secondary Outcomes (88)

• CVLT-II, Short Delay Free Recall 1

  Change from Pre-Treatment Baseline to 1-Week after Series 1

• CVLT-II, Short Delay Free Recall 2

  Change from Pre-Treatment Baseline to 1-Month after Series 1

• CVLT-II, Short Delay Free Recall 3

  Change from 1-Week to 1-Month after Series 1

• CVLT-II, Short Delay Free Recall 4

  Change from Pre-Treatment Baseline to 1-Week after Series 2

• CVLT-II, Short Delay Cued Recall 1

  Change from Pre-Treatment Baseline to 1-Week after Series 1

Study Arms (2)

Real LED Intervention

ACTIVE COMPARATOR

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.

Device: Real LED Intervention

Sham LED Intervention

SHAM COMPARATOR

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.

Device: Real LED Intervention; Device: Sham LED Intervention

Interventions

Real LED Intervention DEVICE

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).

Also known as: Light-Emitting Diode (LED) Therapy, Photobiomodulation (PBM), Vielight Neuro Alpha

Real LED Intervention; Sham LED Intervention

Sham LED Intervention DEVICE

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.

Also known as: Control

Sham LED Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Boston VA Research Institute, Inc.: lead
• VA Boston Healthcare System: collaborator
• Vielight Inc.: collaborator

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Head Injuries, Closed; Cognitive Dysfunction; Stress Disorders, Post-Traumatic

Interventions

Therapeutics; Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Wounds, Nonpenetrating; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Phototherapy

Study Officials

• Paula I Martin, PhD

  VA Boston Healthcare System, Jamaica Plain Campus, Boston, Ma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula I Martin, PhD

CONTACT

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

Michael Ho, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After consent/screening participant is randomized by computer into Group 1 or Group 2 in blocks of 10. The participant, investigator and outcome assessor is blinded to Group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a blinded, randomized, sham-controlled, partial-crossover study with 2 groups (n=10 per group (Sham, Real); ages 18-65). Participants are randomized by computer into group 1 or 2, in blocks of 10. At-home LED intervention is self-administered 3 times per week (20 minutes), for two 5-week series, with a one month break between series. All participants receive a Real Series of treatment at some point during the study.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 18, 2020
• Study Start: August 7, 2019
• Primary Completion: March 31, 2023
• Study Completion: September 30, 2023
• Last Updated: February 25, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)