Effects of LEDs on Memory in TBI Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2013-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcranial LED Treatment

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.

Group Type EXPERIMENTAL

MedX Health Phototherapy (light therapy)

Intervention Type 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.

Interventions

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MedX Health Phototherapy (light therapy)

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

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No