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

NCT02763826 | Completed Results

• 1 other identifier: Pro00022248
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Transcranial Direct Current Stimulation; tDCS

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Major Response

  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

Study Arms (2)

Determine the Optimal tDCS current

EXPERIMENTAL

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

Determine the optimal tDCS electrode montage

EXPERIMENTAL

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

Interventions

transcranial direct current stimulation DEVICE

brain stimulation using progressively increasing amounts of direct currents and in a variety of electrode montages

Also known as: tdcs

Determine the Optimal tDCS current; Determine the optimal tDCS electrode montage

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• Chhatbar PY, Chen R, Deardorff R, Dellenbach B, Kautz SA, George MS, Feng W. Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study. Brain Stimul. 2017 May-Jun;10(3):553-559. doi: 10.1016/j.brs.2017.02.007. Epub 2017 Feb 27.

  PMID: 28279641 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Scott Hutchison, Manager of COBRE Research Operations
• Organization: Medical University or SC

hutchis@musc.edu

843-792-2712

Study Officials

• Wuwei Feng, MD, MS

  MEDICAL UNIVERSITY OF SOUTH CAROL

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: May 5, 2016
• Study Start: December 8, 2014
• Primary Completion: April 26, 2019
• Study Completion: April 26, 2019
• Last Updated: October 13, 2021
• Results First Posted: October 13, 2021

Record last verified: 2021-10

Locations

US (1)