Post-stroke Fatigue, Inflammation, tDCS

Medical University of South Carolina12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Stroke Fatigue Chronic Stroke Stroke Sequelae

Interventions

anodal transcranial direct current stimulation (a-tDCS)DEVICE

The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.

sham stimulationDEVICE

The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

Outcomes

Primary Outcomes

Change in Fatigue Severity Scale (FSS) Score

Patient reported outcome measuring trait fatigue over the past 7 days. Minimum score = 7 maximum score = 63, higher scores indicate greater fatigue

Time frame: Baseline, post-intervention (2-weeks)

Secondary Outcomes

Change in Fatigue Assessment Scale (FAS)

Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue

Time frame: Baseline, post-intervention (2-weeks)

Data from ClinicalTrials.gov

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