Optimizing Current and Electrode Montage for Transcranial Direct Current Stimulation in Stroke Patients (COBRE_JIpro3)

October 12, 2021 updated by: Medical University of South Carolina
The purpose of this study is to determine the optimal transcranial direct current stimulation (tDCS) amplitude and electrode montage that is both safe and efficacious

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that can modulate cortical excitability of targeted brain regions. Various studies have investigated tDCS use in stroke patients with motor impairments (cumulatively about 200 cases). Although these studies are mostly "proof of concept" with small sample size, they do suggest that tDCS may improve motor function. However these two questions have not been addressed systematically:

  1. What is the optimal current for stroke patients?
  2. What is the optimal tDCS electrode montage for stimulation?

This proposal lays the scientific foundation for systematic application of tDCS in stroke recovery research by progressively increasing tDCS currents and montages that are both safe and efficacious in population with stroke.

Study Type

Interventional

Enrollment (Actual)

31

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-80 years old with a first-ever ischemic stroke that occurred at least 6 months ago;
  • Finished rehabilitation therapy(including inpatient or outpatient Physical Therapy (PT) / Occupational Therapy (OT) / Speech Therapy (SP)) at least one month ago;
  • Unilateral limb weakness with Fugl Meyer-Upper Extremity Scale score less than 56 (out of 66);
  • Motor Evoked Potentials (MEP) is inducible on abductor pollicis brevis (APB) muscle on the affected side by TMS.

Exclusion Criteria:

  • Primary intracerebral hematoma, or subarachnoid hemorrhage,
  • Bihemispheric ischemic strokes;
  • History of prior stroke or old infarct demonstrated on the CT or MRI or documented in medical records;
  • Other concomitant neurological disorders affecting upper extremity motor function;
  • Documented history of dementia before or after stroke;
  • Documented history of uncontrolled depression or psychiatric disorder either before or after stroke which could affect their ability to participate in the experiment;
  • Uncontrolled hypertension despite treatment, specifically Systolic blood pressure (SBP)/ Diastolic Blood Pressure (DBP) >= 180/100 mmHg at baseline;
  • Presence of any MRI/tDCS/TMS risk factors: a) an electrically, magnetically or mechanically activated metal or nonmetal implant including cardiac pacemaker, intracerebral vascular clips or any other electrically sensitive support system; b) non-fixed metal in any part of the body, including a previous metallic injury to eye; c) pregnancy, since the effect of tDCS on the fetus is unknown; d) history of seizure disorder or post-stroke seizure; e) preexisting scalp lesion, bone defect or hemicraniectomy.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Determine the Optimal tDCS current
We will invesitigate the optimal curent in range of 1 mA to 4 mA. We hypothesize that 4 mA is tolerable, safe and can induce the highest level of cortical excitability in the lesional motor cortex.
Device: transcranial direct current stimulation
brain stimulation using progressively increasing amounts of direct currents and in a variety of electrode montages
Other Names:
  • tdcs
Experimental: Determine the optimal tDCS electrode montage
We hypothesize that the bi-hemispheric stimulation with anodal stimulation on the lesional hemisphere and simultaneous cathodal stimulation on the non-lesional hemisphere induces more cortical excitability in the lesional hemisphere than either anodal stimulation on the affected hemisphere or cathodal stimulation on non-lesional hemisphere alone.
Device: transcranial direct current stimulation
brain stimulation using progressively increasing amounts of direct currents and in a variety of electrode montages
Other Names:
  • tdcs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Major Response
Time Frame: Immediately after intervention on the day of tDCS application

Major response is any of the following:

  • Second degree scalp burn at the site of electrode pad; or
  • Seizure; or
  • New lesion(s) on Diffusion Weighted Imaging (DWI) sequence of MRI scan and the lesion(s) not explained by any other cause(s) or decreased Apparent Diffusion Coefficient (ADC) under the electrode stimulating motor cortex area;
  • Discontinuation of subject from the study due to any of above.

In a 3+3 design, 3 subjects are recruited for a given tDCS dose level. The trial is stopped if ≥2 of 3 subjects at a given tDCS dose level show major response. If only 1 of 3 subjects shows major response, 3 more subjects are recruited at a given tDCS dose level and a major response in any of them will stop the trial. Otherwise, same procedure is followed for the next tDCS dose level. Maximum tolerable dose will be the tDCS dose at the level before stopping of the trial.
Immediately after intervention on the day of tDCS application

Collaborators and Investigators

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

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Wuwei Feng, MD, MS, MEDICAL UNIVERSITY OF SOUTH CAROL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 8, 2014

Primary Completion (Actual)

April 26, 2019

Study Completion (Actual)

April 26, 2019

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

October 13, 2021

Last Update Submitted That Met QC Criteria

October 12, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00022248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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