N/A
N=12
Post-stroke Fatigue, Inflammation, tDCS
Stroke · Fatigue · Chronic Stroke · Stroke Sequelae
Bottom Line
View on ClinicalTrials.gov: NCT05330988 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Change in Fatigue Severity Scale (FSS) Score — -0.4; 0.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- anodal transcranial direct current stimulation (a-tDCS) (Device); sham stimulation (Device)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Fatigue Severity Scale (FSS) Score |
-0.4; 0.2 | — |
| SECONDARY Change in Fatigue Assessment Scale (FAS) |
-7; -4 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT05330988). 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.