Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

Ischemic Stroke Clinical Trial

Official title:

TDCS-enhanced Stroke Recovery and Cortical Reorganization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01007136
• Other study ID #: STU 092010-231
• Secondary ID: K23HD050267
• Status: Terminated
• Phase: N/A
• Start date: March 2009
• Est. completion date: March 2014

Study information

• Verified date: September 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Epub 2006 Feb 21. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Analog Pain Scale		during therapy
Other	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
Other	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
Other	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
Other	Ashworth Spasticity Scale		3 months
Other	Abilhand Questionnaire		3 months
Other	Motor Activity Log		3 months
Other	fMRI Overactivation in Motor Cortex: Voxel Count and Intensity		3 months
Other	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
Other	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
Primary	Upper Extremity Fugl-Meyer	Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.	2 weeks
Primary	Upper Extremity Fugl-Meyer	Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.	3 months
Primary	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	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