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Post-stroke Fatigue, Inflammation, tDCS

Primary Purpose

Stroke, Fatigue, Chronic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
anodal transcranial direct current stimulation (a-tDCS)
sham stimulation
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Real

Sham

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Fatigue Assessment Scale (FAS)
Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue

Full Information

First Posted
April 8, 2022
Last Updated
April 13, 2023
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
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1. Study Identification

Unique Protocol Identification Number
NCT05330988
Brief Title
Post-stroke Fatigue, Inflammation, tDCS
Official Title
Effects of tDCS on Post-stroke Fatigue and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Fatigue, Chronic Stroke, Stroke Sequelae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Real
Arm Type
Experimental
Arm 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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
anodal transcranial direct current stimulation (a-tDCS)
Other Intervention Name(s)
1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.
Intervention Description
The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
Intervention Type
Device
Intervention Name(s)
sham stimulation
Other Intervention Name(s)
1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.
Intervention Description
The 1x1 platform is the most state-of-the-art, customizable, and reliable platform for pad-based Transcranial Electrical Stimulation.
Primary Outcome Measure Information:
Title
Change in Fatigue Severity Scale (FSS) score
Description
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 Outcome Measure Information:
Title
Change in Fatigue Assessment Scale (FAS)
Description
Patient reported outcome measuring trait fatigue. Minimum score = 10 maximum score = 50, higher scores indicate greater fatigue
Time Frame
Baseline, post-intervention (2-weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Chesnutt
Phone
8437928171
Email
hydar@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Cence
Phone
8437922668
Email
cence@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John H Kindred, Ph.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Cence
Phone
843-792-2668
Email
cence@musc.edu
First Name & Middle Initial & Last Name & Degree
Alyssa Chesnutt
Phone
8437928171
Email
hydar@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Post-stroke Fatigue, Inflammation, tDCS

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