N/A N=88 Randomized Single-blind Treatment

Treatment of Post-Traumatic Brain Injury (Post-TBI) Fatigue With Light Therapy

Traumatic Brain Injury · Fatigue

Bottom Line

View on ClinicalTrials.gov: NCT01725750 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcome: Primary: Multidimensional Assessment of Fatigue (MAF) — 33.332; 30.531; 27.993; 24.937 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Bright White Light (BWL) (Device); Dim Red Light (DRL) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Icahn School of Medicine at Mount Sinai
Primary completion: Jun 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.