N/A
Completed N=88
Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy
Source: ClinicalTrials.gov NCT01725750 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Multidimensional Assessment of Fatigue (MAF) — 33.332; 30.531; 27.993; 24.937 score on a scale
Summary
This study aims to evaluate the efficacy of 4 weeks of daily light exposure in reducing Post-Traumatic Brain Injury (TBI) Fatigue immediately post-treatment and at a one-month follow up. The investigators hypothesize that individuals receiving 4 weeks of bright white light treatment will report significant reductions in fatigue compared to individuals receiving dim red light treatment for the same duration of time, and that these treatment effects will be maintained one month after treatment completion.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Multidimensional Assessment of Fatigue (MAF) |
33.332; 30.531; 27.993; 24.937; 28.658; 25.350 | — |
| SECONDARY TBI-QOL Fatigue |
61.819; 58.821; 58.071; 55.724; 58.226; 57.252 | — |
| SECONDARY Neuro-QOL Depression and Sleep |
52.893; 82.942; 53.337; 52.864; 55.162; 52.290 | — |
| SECONDARY Epworth Sleepiness Scale (ESS) |
9.695; 6.970; 8.162; 8.312; 8.169; 8.133 | — |
| SECONDARY CNS Vital Signs TBI Rehab Toolbox |
79.59; 82.83; 83.19; 77.64; 86.17; 79.10 | — |
| SECONDARY Cognitive Failures Questionnaire |
47.823; 42.806; 45.261; 46.564; 47.503; 45.352 | — |
| SECONDARY Neuro-QOL Anxiety |
55.725; 56.253; 55.250; 56.661; 57.441; 55.226 | — |
| SECONDARY Actiwatch Spectrum - Acrophase |
15.68; 15.98 | — |
| SECONDARY Actiwatch Spectrum - Mesor |
0.72; 0.83 | — |
| SECONDARY Actiwatch Spectrum - F Statistic |
1765.36; 2307.38 | — |
| SECONDARY Satisfaction With Life Scale |
17.409; 18.698; 17.622; 18.394; 17.441; 19.900 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication |
42.455; 47.546 | — |
| SECONDARY Credibility/Expectancy Questionnaire |
-.5539; .4489 | — |
Eligibility Criteria
Inclusion Criteria
- Documented TBI of any severity
- At least 6 months post injury
- Presence of clinically significant fatigue, operationalized as a score of 22 or more on the Multidimensional Assessment of Fatigue
- Age 18 or older
- English speaking
Exclusion Criteria
- Neurological disease other than TBI
- Pregnancy (because of pregnancy fatigue)
- Medical illness causing fatigue, such as anemia, hypothyroidism, HIV, renal failure, cirrhosis or cancer treatment in the past year
- Current major depressive episode or substance abuse
- Diagnosed sleep disorder or high risk for sleep apnea
- History of bipolar disorder or manic or hypomanic episodes
- Current chronic, severe headaches
- Sensitivity to bright light
- History of retinal damage or disease
Data sourced from ClinicalTrials.gov (NCT01725750). 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. Informational only — not medical advice.