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NCT Number: NCT02404402

LED Treatment to Improve Cognition and Promote Recovery in TBI

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).

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Nervous System Diseases Posttraumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Nervous System Wounds and Injuries

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02130-4817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LED

Other

Low Level Light Therapy

sham LED

Other

Inactive (sham) LED treatment

Primary outcomes

  1. Cognitive Functioning_Attention/Executive

    Time frame: Eight Weeks

    Stroop Test ("Color-Word" test; Delis, Kaplan & Kramer, 2001)

  2. Cognitive Functioning_Learning/Memory

    Time frame: Eight weeks

    California Verbal Learning Test-II (CVLT-II; Delis, Kramer, Kaplan, & Ober, 2000)

Secondary outcomes

  1. Neuropsychiatric Status/Mood

    Time frame: Eight weeks

    Beck Depression inventory (BDI; Beck, 2006)

  2. Neuropsychiatric status/PTSD

    Time frame: Eight weeks

    PTSD Checklist - Military Version (PCL-M)

  3. Neuropsychiatric status/Sleep

    Time frame: Eight weeks

    Pittsburgh Sleep Quality Index (PSQI; Buysse et al., 1989)

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Noninvasive LED Treatment to Improve Cognition and Promote Recovery in Blast TBI

Acronym: LED-TBI

Important dates

Study start
2015
Primary completion
2025
Study completion
2025
First posted
Mar 31, 2015
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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