N/A
N=22
Effects of LEDs on Memory in TBI Patients
Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT01598532 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Stroop Test for Executive Function - Trial 3 - Inhibition — -0.7407; .036; .718; .815 # of SD units — p=<0.004
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MedX Health Phototherapy (light therapy) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Spaulding Rehabilitation Hospital
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stroop Test for Executive Function - Trial 3 - Inhibition |
-0.7407; .036; .718; .815 | <0.004 sig |
| PRIMARY Stroop Test for Executive Function - Trial 4 Inhibition Switching |
-1.050; -0.100; .553; .854 | <0.003 sig |
| PRIMARY California Verbal Learning Test-II (CVLT-II) Total, Trials 1-5 |
-.409; .364; .630; .780 | <0.003 sig |
| PRIMARY California Verbal Learning Test-II (CVLT-II) Long Delay Free Recall |
-1.136; -0.136; -0.200; 0.050 | <0.006 sig |
| PRIMARY Controlled Oral Word Association Test (FAS) |
-.318; .136; .114; .285 | — |
| PRIMARY Digit Span, Forwards and Backwards |
-.182; .318; .444; .650 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT01598532). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.