Effects of tDCS on Post-stroke Fatigue and Inflammation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Change in Fatigue Severity Scale (FSS) Score
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Real
Randomly selected participants will receive 20 min. of anodal transcranial direct current stimulation to the the top of their heads. The current will slowly be ramped up over 30 secs.
Intervention: anodal transcranial direct current stimulation (a-tDCS) (Device)
Sham
Randomly selected participants will receive 20 min. of sham transcranial direct current stimulation to the top of their heads. Sham stimulation is accomplished by turning on the device and slowly increasing and subsequently decreasing the amount of current to zero. This occurs over 30 secs.
Intervention: sham stimulation (Device)
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))
Investigators
John H Kindred
Principle Investigator
Medical University of South Carolina