Post-stroke Fatigue, Inflammation, tDCS

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Stroke; Stroke Sequelae; Chronic Stroke; Fatigue

Treatments: Device: sham stimulation; Device: anodal transcranial direct current stimulation (a-tDCS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05330988

00118687

P2CHD086844 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 2 patient groups

Real

Experimental group

Description:

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.

Treatment:

Device: anodal transcranial direct current stimulation (a-tDCS)

Sham

Sham Comparator group

Description:

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.

Treatment:

Device: sham stimulation