Effects of LEDs on Memory in TBI Patients
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | March 2013 |
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.
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.
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.
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)
We found this trial at
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Spaulding Rehabilitation Hospital At Spaulding Rehabiliation Hospital Boston, our unique approach to therapy includes use...
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