Real LED Intervention for Traumatic Brain Injury

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

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
Cognitive Impairment
Head Injuries

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CVLT-II, Long Delay Free Recall 1

CVLT-II, Long Delay Free Recall 2

CVLT-II, Long Delay Free Recall 3

+1 more

Secondary study objectives

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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