Effects of LEDs on Memory in TBI Patients

Traumatic Brain Injury Clinical Trial

— LED  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01598532
• Other study ID #: 2009-P-001552
• Status: Completed
• Phase: N/A
• First received: May 4, 2012
• Last updated: July 23, 2015
• Start date: September 2009
• Est. completion date: March 2013

Study information

• Verified date: July 2015
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Device:
• MedX Health Phototherapy (light and laser 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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

Hashmi JT, Huang YY, Osmani BZ, Sharma SK, Naeser MA, Hamblin MR. Role of low-level laser therapy in neurorehabilitation. PM R. 2010 Dec;2(12 Suppl 2):S292-305. doi: 10.1016/j.pmrj.2010.10.013. Review. — View Citation

Naeser MA, Saltmarche A, Krengel MH, Hamblin MR, Knight JA. Improved cognitive function after transcranial, light-emitting diode treatments in chronic, traumatic brain injury: two case reports. Photomed Laser Surg. 2011 May;29(5):351-8. doi: 10.1089/pho.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropsychological Test Battery (outcome Measures)	The Neuropsychological Test Battery will be at pre-LED Treatment (prior to intervention begins) for Baseline results. Neuropsychological Test Battery will be at repeated at 1 week, 1 month and 2 months following end of LED treatments to look for changes from Baseline results. The primary outcome metric is change in the Test Battery	4 months in duration	No

External Links

•   Department of Physical Medicine and Rehabilitation at Spaulding Hospital - Research