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LED Treatment to Improve Cognition and Promote Recovery in TBI (LED-TBI)

VA Office of Research and Development logo

VA Office of Research and Development

Status

Active, not recruiting

Conditions

Posttraumatic Stress Disorder
Traumatic Brain Injury

Treatments

Other: sham LED
Other: LED

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02404402
N1773-P

Details and patient eligibility

About

This study investigates the efficacy of a novel neuromodulation treatment, light emitting diodes (LED), on cognition, neuropsychiatric status and quality of life in individuals with traumatic brain injury (TBI).

Full description

The most common traumatic brain injury (TBI)-associated problems are cognitive deficits and neuropsychiatric problems, such as sleep disturbance and PTSD. This study evaluates a novel neuromodulation intervention, light emitting diodes (LED), for treatment of patients with TBI. LED is a noninvasive, non-thermal, painless treatment, which does not involve any needles or any form of surgery. LED treatment improves cellular activity of the brain tissue that has been damaged by TBI. Half of the study participants will receive active LED treatment, and a control group will receive sham LED. This study takes place in Boston, Massachusetts: at the VA Boston Healthcare System.

Enrollment

8 patients

Sex

All

Ages

21 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Inclusion Criteria:

  • OEF/OIF active-duty personnel or Veterans with history of TBI or blast-exposure
  • Meets criteria for mild TBI
  • LOC of 30 min or less
  • Age: 21-55
  • Primary language is English

Exclusion criteria

  • Evidence of penetrating head injury
  • History of previous neurological diagnosis
  • History of previous psychotic disorder prior to TBI
  • Hearing or vision impairment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

8 participants in 2 patient groups

Active LED
Experimental group
Description:
Active LED Treatment
Treatment:
Other: LED
Sham LED
Sham Comparator group
Description:
Inactive (sham) LED Treatment
Treatment:
Other: sham LED

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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