Clinical trial NCT01598532: Effects of LEDs on Memory in TBI Patients
Official title: Treatment of Cognitive Dysfunction in Mild TBI With Transcranial Light Emitting Diodes- An Open Protocol, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: mild traumatic brain injury
mild TBI
mTBI
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Stroop Test for Executive Function - Trial 3 - Inhibition
timeFrame: Baseline and 1-Week, 1-month and 2-months after final LED Treatment
measure: Stroop Test for Executive Function - Trial 4 Inhibition Switching
timeFrame: Baseline and 1-Week, 1-Month and 2-Months after the Final LED Treatment
measure: California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5
timeFrame: Baseline and 1-Week, 1-Month and 2-Months after Final LED Treatment
measure: California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall
timeFrame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
measure: Controlled Oral Word Association Test (FAS)
timeFrame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
measure: Digit Span, Forwards and Backwards
timeFrame: Baseline and 1-Week, 1-Month and 2-Months after final LED Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Ross D Zafonte, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.2010.2814. Epub 2010 Dec 23.