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

NCT ID: NCT02763826

Last Updated: 2021-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-08
• Study Completion Date: 2019-04-26

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

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.

Conditions

Stroke

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

transcranial direct current stimulation

Intervention Type: DEVICE

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

Interventions

transcranial direct current stimulation

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

Intervention Type: DEVICE

Other Intervention Names

tdcs

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wuwei Feng, MD, MS

Role: PRINCIPAL_INVESTIGATOR

MEDICAL UNIVERSITY OF SOUTH CAROL

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28279641 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Pro00022248

Identifier Type: -

Identifier Source: org_study_id