Post-stroke Fatigue, Inflammation, tDCS

Not Applicable

Completed

• Conditions: Fatigue; Stroke Sequelae; Stroke; Chronic Stroke
• Interventions: Device: anodal transcranial direct current stimulation (a-tDCS); Device: sham stimulation

• 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

Arm && Interventions

Group	Intervention	Description
Real	anodal transcranial direct current stimulation (a-tDCS)	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.
Sham	sham stimulation	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.

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