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Completed

NCT Number: NCT01598532

Effects of LEDs on Memory in TBI Patients

The purpose of the study is to investigate whether transcranial, high-intensity LED placed on the scalp can improve working memory in people who have sustained a concussion with lingering effects or a mild brain injury.

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Key information

Conditions

Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

About this study

This is a four month, outpatient, single center study investigating whether transcranial, high intensity LED applied outside the skull can improve frontal lobe executive function and working memory in participants with chronic, mild Traumatic Brain Injury (TBI), with or without mild posttraumatic stress disorder (PTSD), due to closed head injury.

Participants will sign the Informed Consent Form(ICF) before Neuropsychological Screening test are administered. If the participant's neuropsychological screening test scores meet the Inclusion/Exclusion criteria and the participant meets the other Inclusion/Exclusion criteria, then he/she will be tested again on the tests that are part of the Neuropsychological Outcome Measures, the week before the Transcranial LED treatments, and during the week after the last LED treatment and again at one and two months after the last LED treatment. Treatment with Transcranial LED will be for 6 weeks. Participants will be treated three times per week: Monday, Wednesday and Friday. A total of 18 Transcranial LED treatments will be administered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, Ages 18-65
  • sustained a mild traumatic brain injury(mTBI) at least 6 months ago
  • mTBI is defined as < 30 minutes loss of consciousness and <30 minutes, post trauma amnesia
  • since the injury patient continues having problems with memory and thinking ability

Exclusion criteria

  • Younger than 18 or older than 65
  • mTBI occured less than 6 months ago
  • moderate to severe Traumatic Brain Injury (TBI)
  • non-closed head injury
  • presence of craniotomy, craniectomy, or ventriculoperitoneal shunt
  • Non-English speaking subjects - Neuropsychological Tests only in English
  • Neuropsychological Screening Test Scores not at least 2 SD below norm on one of the neuropsychological tests or not 1 SD below norm on at least two of the tests administered during screening)

Treatment and study plan

MedX Health Phototherapy (light therapy)

Device

The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.

Primary outcomes

  1. Stroop Test for Executive Function - Trial 3 - Inhibition

    Time frame: Baseline and 1-Week, 1-month and 2-months after final LED Treatment

    Stroop Test for Executive Function - Trial 3 (D-KEFS) - Inhibition measures executive function, inhibition that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

  2. Stroop Test for Executive Function - Trial 4 Inhibition Switching

    Time frame: Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment

    Stroop Test for Executive Function - Trial 4 (D-KEFS) Inhibition Switching that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

  3. California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5

    Time frame: Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment

    California Verbal Learning Test-II (CVLT-II) Total, Trials 1 - 5 measures word recall on trials 1-5 that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

  4. California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall

    Time frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment

    California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall measures word recall after a 20 minute delay that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

  5. Controlled Oral Word Association Test (FAS)

    Time frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment

    Controlled Oral Word Association Test (FAS) measures verbal fluency that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

  6. Digit Span, Forwards and Backwards

    Time frame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment

    Digit Span, Forwards and Backwards measures short-term auditory memory and working memory that has been converted to Z-score, # of Standard Deviation units. Higher Mean scores equals better outcomes.

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Registry information

Official study title

Treatment of Cognitive Dysfunction in Mild TBI With Transcranial Light Emitting Diodes- An Open Protocol, Pilot Study

Acronym: LED

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
May 15, 2012
Registry last updated
Sep 30, 2016

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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