Post-stroke Fatigue, Inflammation, tDCS

NCT05330988 | Completed Results FDA Device

• 2 other identifiers: 00118687P2CHD086844
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Fatigue; Chronic Stroke; Stroke Sequelae

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Fatigue Assessment Scale (FAS)

  Baseline, post-intervention (2-weeks)

Study Arms (2)

Real

EXPERIMENTAL

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)

Sham

SHAM COMPARATOR

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

Interventions

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.

Also known as: 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.

Real

sham stimulation DEVICE

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

Also known as: 1x1 - tDCS, Soterix Medical, US Patents: US9956395B2, US8818515B2, US8718778B2.

Sham

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women of any race or ethnicity
• years of age
• + months post-stroke
• Have clinically present fatigue for 6 months
• Able to walk 10m unassisted

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• National Center of Neuromodulation for Rehabilitation: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Stroke; Fatigue

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr. John H. Kindred
• Organization: Department of Veterans Affairs

john.kindred1@va.gov

8437924328

Study Officials

• John H Kindred, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: July 12, 2022
• Primary Completion: October 31, 2023
• Study Completion: March 1, 2024
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Immediately following publication no end date
• Access Criteria: anyone who wishes to access the data

Locations

US (1)