Traumatic Brain Injury Clinical Trial
Official title:
Treatment of Cognitive Dysfunction in Mild TBI With Transcranial Light Emitting Diodes- An Open Protocol, Pilot Study
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.
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.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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