In-home light therapy for fatigue following traumatic brain injury: A pilot randomized controlled trial

Not Applicable

Recruiting

• Conditions: Traumatic brain injury; Injuries and Accidents - Other injuries and accidents; Neurological - Other neurological disorders; Stroke - Haemorrhagic; Stroke - Ischaemic

• Registration Number: ACTRN12617000866303
• Lead Sponsor: Epworth HealthCare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-13
• Last Update Posted: 21 September 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Inclusion criteria for the study includes presence of mild, moderate or severe TBI, as ascertained by scores on the Glasgow Coma Scale (GCS) and duration of post-traumatic amnesia (PTA), and self-reported significant fatigue (Fatigue Severity Scale greater than or equal to 4). Participants injury should have occurred at least three months prior, and they must have been discharged from the hospital.

Exclusion Criteria

Exclusion criteria include any comorbid psychiatric disorders requiring hospitalization. Depressive symptoms are a secondary outcome, which will be assessed in both conditions of the light intervention. The use of antidepressants will be permitted provided a stable dosage is maintained across the course of the study. Additional exclusion criteria include the presence of another medical illness accounting for fatigue, including other neurological disorders, pre-injury sleep disorders or chronic fatigue syndrome, transmeridian travel within the preceding six weeks, current use of prescribed and over the counter sleep medications and inability to give informed consent as assessed by the participant’s treating neuropsychologist.

Study & Design

• Study Type: Interventional
• Study Design: Not specified