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OpenTrials
Completed

NCT Number: NCT05330988

Post-stroke Fatigue, Inflammation, tDCS

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chronic Stroke Fatigue Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Sequelae Vascular Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.

Sham stimulation

Device

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

Other names: 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.

Primary outcomes

  1. 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

  1. Change in Fatigue Assessment Scale (FAS)

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

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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center of Neuromodulation for Rehabilitation

Registry information

Official study title

Effects of tDCS on Post-stroke Fatigue and Inflammation

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Apr 15, 2022
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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