Post-stroke Fatigue, Inflammation, tDCS

Stroke Clinical Trial

Official title:

Effects of tDCS on Post-stroke Fatigue and Inflammation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05330988
• Other study ID #: 00118687
• Secondary ID: P2CHD086844
• Status: Completed
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 1, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Fatigue
• Inflammation
• Stroke
• Stroke Sequelae

Intervention

Device:
• anodal transcranial direct current stimulation (a-tDCS)
The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
• sham stimulation
The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center of Neuromodulation for Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, post-intervention (2-weeks)
Secondary	Change in Fatigue Assessment Scale (FAS)	Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue	Baseline, post-intervention (2-weeks)