NCT01598532

Effects of LEDs on Memory in TBI Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Spaulding Rehabilitation Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-05-15
• Last updated: 2016-09-30
• Results posted: 2016-08-22

Locations

1 site across 1 country: United States