Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

TDCS-enhanced Stroke Recovery and Cortical Reorganization

The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.

Study Overview

• Status: Terminated
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: tDCS; Device: Sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ischemic stroke causing arm weakness within 5-15 days
• no other neurological or psychiatric disease, who are able to perform study tasks

Exclusion Criteria:

• patients younger than 18 or older than 80 years
• patients with more than one disabling stroke
• Patients with bilateral motor impairment
• Patients with poor motivational capacity, history of severe alcohol or drug abuse
• Patients with severe language disturbances, particularly of receptive nature
• Patients with serious cognitive deficits (defined as equivalent to a MMS score of 23 or less)
• Patients with severe uncontrolled medical problems (e.g., seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age or others),
• Patients with unstable thyroid disease
• Patients with increased intracranial pressure
• Patients with unstable cardiac arrhythmia
• Patients with contraindication to TMS or tDCS stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation)
• Patients who are not available for follow-up at 3 and 12 months
• Pregnancy
• Patients with contraindication to MRI will not participate in MRI

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS and occupational therapy; 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.	Device: tDCS; 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.; Other Names: Transcranial Direct Current Stimulation; Electric stimulation
Sham Comparator: Sham and occupational therapy; Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.	Device: Sham tDCS; Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity Fugl-Meyer	Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.	2 weeks
Upper Extremity Fugl-Meyer	Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.	3 months
Upper Extremity Fugl-Meyer	Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.	1 year after stroke

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wolf Motor Function Test	The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability determined through the use of timed and functional tasks. The score represents the average speed the subject could perform of the timed motor tasks. The score is the average of the scores calculated from "how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds". The score ranges from 0 to no theoretical maximum, with higher numbers meaning faster/ better performance. (See publication Dr. Hodics et al. 2012.)	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Scale		during therapy
Mini Mental Status Scale	Mini Mental Status Scale is a test of cognitive function; it includes tests of orientation, attention, memory, language and visual-spatial skills, scored 0-30, the higher scores mean the better performance.	3 months
NIHSS	The National Institutes of Health Stroke Scale (NIHSS) provides a quantitative measure of stroke-related neurologic deficit. The NIHSS was originally designed as a research tool to measure baseline data on patients in acute stroke clinical trials. The score ranges 0-42, a score of 0 represents no deficit, lower score is better.	3 months
Beck Depression Inventory	21-item, self-rated scale that evaluates key symptoms of depression. The minimum score is 0 and maximum score is 63. Higher scores indicate greater symptom severity.	3 months
Ashworth Spasticity Scale		3 months
Abilhand Questionnaire		3 months
Motor Activity Log		3 months
fMRI Overactivation in Motor Cortex: Voxel Count and Intensity		3 months
Barthel Index	The Barthel Scale/Index (BI) is an ordinal scale used to measure performance in activities of daily living. Ten variables describing activities of daily living and mobility are scored. The total score ranges 0-100, a higher number being a reflection of greater ability to function independently following hospital discharge.	3 months
Medical Research Council (MRC) Scale	The muscle scale grades muscle strength on a scale of 0 to 5 in relation to the maximum expected for that muscle. The patient's effort is graded on a scale of 0 (no movement) -5 (muscle contracts normally against full resistance).	3 months

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
• Hidler J, Hodics T, Xu B, Dobkin B, Cohen LG. MR compatible force sensing system for real-time monitoring of wrist moments during fMRI testing. J Neurosci Methods. 2006 Sep 15;155(2):300-7. doi: 10.1016/j.jneumeth.2006.01.016. Epub 2006 Feb 21.
• Hodics TM, Nakatsuka K, Upreti B, Alex A, Smith PS, Pezzullo JC. Wolf Motor Function Test for characterizing moderate to severe hemiparesis in stroke patients. Arch Phys Med Rehabil. 2012 Nov;93(11):1963-7. doi: 10.1016/j.apmr.2012.05.002. Epub 2012 May 10.
• Hodics T, Cohen LG, Pezzullo JC, Kowalske K, Dromerick AW. Barriers to Enrollment in Post-Stroke Brain Stimulation in a Racially and Ethnically Diverse Population. Neurorehabil Neural Repair. 2022 Sep;36(9):596-602. doi: 10.1177/15459683221088861. Epub 2022 Aug 4.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: November 2, 2009
• First Submitted That Met QC Criteria: November 2, 2009
• First Posted (Estimate): November 3, 2009

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: tDCS; stroke; functional MRI; TMS
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: STU 092010-231; K23HD050267 (U.S. NIH Grant/Contract)