Post-stroke Fatigue, Inflammation, tDCS

Not Applicable

Completed

• Conditions: Fatigue; Stroke Sequelae; Stroke; Chronic Stroke

• Registration Number: NCT05330988
• Lead Sponsor: Medical University of South Carolina

Brief Summary

Fatigue is a common condition after an individual has a stroke. While the negative impacts of post-stroke fatigue are well known, the knowledge of the causes of post-stroke fatigue and effective treatments for post-stroke fatigue are lacking. This small study will investigate the possible benefits of transcranial direct current stimulation (tDCS), which uses small electrical currents supplied by a 9-volt battery, on post-stroke fatigue and investigate tDCS' possible anti-inflammatory effects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2022-07-12
• Primary Completion: 2023-10-31
• Study Completion: 2024-03-01
• Results First Submitted: 2024-10-18
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Results First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Men and women of any race or ethnicity
• 35-80 years of age
• 6+ months post-stroke
• Have clinically present fatigue for 6 months
• Able to walk 10m unassisted

Exclusion Criteria

• Absolute contraindications to MRI, TMS (transcranial magnetic stimulation), or tDCS (e.g., implanted metal devices, history of seizure, and surgical clips or staples)
• Inability to understand and provide written informed consent
• Multiple strokes on opposite hemispheres
• Diagnosed comorbid neurological conditions (e.g. multiple sclerosis, Parkinson's disease, and dementia)
• Severe hypertension
• Cerebellar or brainstem strokes/lesions
• Concurrent depression and/or anxiety disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Fatigue Severity Scale (FSS) Score	Baseline, post-intervention (2-weeks)	Patient reported outcome measuring trait fatigue over the past 7 days. Minimum score = 7 maximum score = 63, higher scores indicate greater fatigue

Secondary Outcome Measures

Name	Time	Method
Change in Fatigue Assessment Scale (FAS)	Baseline, post-intervention (2-weeks)	Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States