Effects of LEDs on Memory in TBI Patients

Mass General Brigham

Status: Completed

Conditions: Traumatic Brain Injury

Treatments: Device: MedX Health Phototherapy (light therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT01598532

2009-P-001552

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Transcranial LED Treatment

Experimental group

Description:

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.

Treatment:

Device: MedX Health Phototherapy (light therapy)