Back to resultsTranscranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery
Primary Purpose
Ischemic Stroke
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sham tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring tDCS, stroke, functional MRI, TMS
Eligibility Criteria
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
Sites / Locations
- University of Texas Southwestern Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
tDCS and occupational therapy
Sham and occupational therapy
Arm Description
1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Outcomes
Primary Outcome Measures
Upper Extremity Fugl-Meyer
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Upper Extremity Fugl-Meyer
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Upper Extremity Fugl-Meyer
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Secondary Outcome Measures
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.)
Full Information
NCT ID
NCT01007136
First Posted
November 2, 2009
Last Updated
September 18, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01007136
Brief Title
Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery
Official Title
TDCS-enhanced Stroke Recovery and Cortical Reorganization
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Funding limit reached due to slower then anticipated recruitment.
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
tDCS, stroke, functional MRI, TMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tDCS and occupational therapy
Arm Type
Experimental
Arm Description
1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
Arm Title
Sham and occupational therapy
Arm Type
Sham Comparator
Arm Description
Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
Transcranial Direct Current Stimulation, Electric stimulation
Intervention Description
1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Primary Outcome Measure Information:
Title
Upper Extremity Fugl-Meyer
Description
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Time Frame
2 weeks
Title
Upper Extremity Fugl-Meyer
Description
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Time Frame
3 months
Title
Upper Extremity Fugl-Meyer
Description
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Time Frame
1 year after stroke
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test
Description
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.)
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Visual Analog Pain Scale
Time Frame
during therapy
Title
Mini Mental Status Scale
Description
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.
Time Frame
3 months
Title
NIHSS
Description
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.
Time Frame
3 months
Title
Beck Depression Inventory
Description
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.
Time Frame
3 months
Title
Ashworth Spasticity Scale
Time Frame
3 months
Title
Abilhand Questionnaire
Time Frame
3 months
Title
Motor Activity Log
Time Frame
3 months
Title
fMRI Overactivation in Motor Cortex: Voxel Count and Intensity
Time Frame
3 months
Title
Barthel Index
Description
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.
Time Frame
3 months
Title
Medical Research Council (MRC) Scale
Description
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).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16490258
Citation
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.
Results Reference
background
PubMed Identifier
22579647
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.
Results Reference
background
PubMed Identifier
35925037
Citation
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.
Results Reference
derived
PubMed Identifier
33175411
Citation
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.
Results Reference
derived
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Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery
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