Post-stroke Fatigue, Inflammation, tDCS

March 25, 2024 updated by: John H Kindred, Medical University of South Carolina

Effects of tDCS on Post-stroke Fatigue and Inflammation

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real
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.
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.
Other Names:
  • 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.
Sham Comparator: Sham
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.
Device: sham stimulation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, post-intervention (2-weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, post-intervention (2-weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

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

Investigators

  • Principal Investigator: John H Kindred, Ph.D., Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2022

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

April 8, 2022

First Submitted That Met QC Criteria

April 8, 2022

First Posted (Actual)

April 15, 2022

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00118687
  • P2CHD086844 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data that underlie the results reported in the article, after de-identification.

IPD Sharing Time Frame

Immediately following publication no end date

IPD Sharing Access Criteria

anyone who wishes to access the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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