Effects of LEDs on Memory in TBI Patients

Not Applicable

Completed

Conditions: Traumatic Brain Injury

Interventions: Device: MedX Health Phototherapy (light therapy)

Registration Number: NCT01598532

Lead Sponsor: Spaulding Rehabilitation Hospital

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transcranial LED Treatment	MedX Health Phototherapy (light therapy)	All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.

Primary Outcome Measures

Name	Time	Method
Stroop Test for Executive Function - Trial 3 - Inhibition	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.
Stroop Test for Executive Function - Trial 4 Inhibition Switching	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.
California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5	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.
California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall	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.
Controlled Oral Word Association Test (FAS)	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.
Digit Span, Forwards and Backwards	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.