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Clinical Trials/NCT05330988
NCT05330988
Completed
Not Applicable

Effects of tDCS on Post-stroke Fatigue and Inflammation

Medical University of South Carolina1 site in 1 country12 target enrollmentJuly 12, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Medical University of South Carolina
Enrollment
12
Locations
1
Primary Endpoint
Change in Fatigue Severity Scale (FSS) Score
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2022
End Date
March 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

John H Kindred

Principle Investigator

Medical University of South Carolina

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Fatigue Severity Scale (FSS) Score

Time Frame: 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 Outcomes

  • Change in Fatigue Assessment Scale (FAS)(Baseline, post-intervention (2-weeks))

Study Sites (1)

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