Ischemic Stroke
Conditions
Keywords
tDCS, stroke, functional MRI, TMS
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.
Interventions
DEVICEtDCS
1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
DEVICESham tDCS
Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Upper Extremity Fugl-Meyer | 2 weeks | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test | 3 months | 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.) |
Other
| Measure | Time frame | Description |
|---|---|---|
| NIHSS | 3 months | 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. |
| Beck Depression Inventory | 3 months | 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. |
| Ashworth Spasticity Scale | 3 months | — |
| Abilhand Questionnaire | 3 months | — |
| Visual Analog Pain Scale | during therapy | — |
| fMRI Overactivation in Motor Cortex: Voxel Count and Intensity | 3 months | — |
| Barthel Index | 3 months | 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. |
| Medical Research Council (MRC) Scale | 3 months | 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). |
| Motor Activity Log | 3 months | — |
| Mini Mental Status Scale | 3 months | 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. |
Countries
United States
Participant flow
Recruitment details
UT SOuthwestern Hospitals, rehabilitation and stroke clinics were screened for eligible stroke patients from 2009 through 2014.
Pre-assignment details
Enrolled participants were assigned to groups unless they were found to meet one of the exclusion criteria, or withdrew their consent.
Participants by arm
| Arm | Count |
|---|---|
| tDCS and Occupational Therapy 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.
tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. | 19 |
| Sham and Occupational Therapy Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. | 17 |
| fMRI Control Group no Intervention Healthy volunteers and chronic stroke volunteers were enrolled in the fMRI and TMS component of the study, no intervention was performed. | 15 |
| tDCS and no Arm Movement 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. Same inclusion criteria as the main group except for no UE movement at enrollment.
tDCS: 1 mA electric current was delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. | 6 |
| Sham and no Arm Movement Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.
Sham tDCS: Electric current was ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. | 4 |
| Total | 61 |
Baseline characteristics
| Characteristic | tDCS and Occupational Therapy | Sham and Occupational Therapy | fMRI Control Group no Intervention | tDCS and no Arm Movement | Sham and no Arm Movement | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 5 Participants | 0 Participants | 4 Participants | 1 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 12 Participants | 15 Participants | 2 Participants | 3 Participants | 42 Participants |
| Age, Continuous | 62.5 years STANDARD_DEVIATION 11.3 | 60.7 years STANDARD_DEVIATION 10.3 | 49 years STANDARD_DEVIATION 13 | 66 years STANDARD_DEVIATION 10 | 63.5 years STANDARD_DEVIATION 8.3 | 59 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 9 Participants | 3 Participants | 1 Participants | 32 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 6 Participants | 3 Participants | 3 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 19 | 0 / 17 | 0 / 15 | 0 / 6 | 0 / 4 |
| other Total, other adverse events | 9 / 19 | 3 / 17 | 0 / 15 | 2 / 6 | 0 / 4 |
| serious Total, serious adverse events | 2 / 19 | 2 / 17 | 0 / 15 | 0 / 6 | 0 / 4 |
Outcome results
Primary
Upper Extremity Fugl-Meyer
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Time frame: 2 weeks
Population: All subjects with outcome data at the prespecified follow-up timepoint were included.~fMRI Control Group no Intervention subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS and Occupational Therapy | Upper Extremity Fugl-Meyer | 30.2 units on a scale | Standard Deviation 21.2 |
| Sham and Occupational Therapy | Upper Extremity Fugl-Meyer | 36.8 units on a scale | Standard Deviation 22.4 |
| tDCS and no Arm Movement | Upper Extremity Fugl-Meyer | 8.2 units on a scale | Standard Deviation 10.2 |
| Sham and no Arm Movement | Upper Extremity Fugl-Meyer | 4.5 units on a scale | Standard Deviation 1 |
Primary
Upper Extremity Fugl-Meyer
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Time frame: 3 months
Population: All subjects with outcome data at the prespecified follow-up timepoint were included.~fMRI Control Group no Intervention subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS and Occupational Therapy | Upper Extremity Fugl-Meyer | 32.4 units on a scale | Standard Deviation 24.5 |
| Sham and Occupational Therapy | Upper Extremity Fugl-Meyer | 47.7 units on a scale | Standard Deviation 18.7 |
| tDCS and no Arm Movement | Upper Extremity Fugl-Meyer | 9.7 units on a scale | Standard Deviation 9.8 |
| Sham and no Arm Movement | Upper Extremity Fugl-Meyer | 4.0 units on a scale | Standard Deviation 0 |
Primary
Upper Extremity Fugl-Meyer
Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance.
Time frame: 1 year after stroke
Population: All subjects with outcome data at the prespecified follow-up timepoint were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS and Occupational Therapy | Upper Extremity Fugl-Meyer | 32.6 units on a scale | Standard Deviation 29.2 |
| Sham and Occupational Therapy | Upper Extremity Fugl-Meyer | 56.0 units on a scale | Standard Deviation 12.8 |
| Sham and no Arm Movement | Upper Extremity Fugl-Meyer | 4.0 units on a scale | Standard Deviation 0 |
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.)
Time frame: 3 months
Population: All subjects with outcome data at the prespecified follow-up timepoint were included.~fMRI Control Group no Intervention subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS and Occupational Therapy | Wolf Motor Function Test | 19.7 units on a scale | Standard Deviation 19.6 |
| Sham and Occupational Therapy | Wolf Motor Function Test | 30.9 units on a scale | Standard Deviation 21.7 |
| tDCS and no Arm Movement | Wolf Motor Function Test | 0.80 units on a scale | Standard Deviation 1.12 |
| Sham and no Arm Movement | Wolf Motor Function Test | 0.79 units on a scale | Standard Deviation 0 |
Other Pre-specified
Abilhand Questionnaire
Time frame: 3 months
Other Pre-specified
Ashworth Spasticity Scale
Time frame: 3 months
Other Pre-specified
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.
Time frame: 3 months
Population: All participants with available data were included. fMRI Control Group no Intervention subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS and Occupational Therapy | Barthel Index | 66.4 score on a scale | Standard Deviation 12.1 |
| Sham and Occupational Therapy | Barthel Index | 82.5 score on a scale | Standard Deviation 16 |
| tDCS and no Arm Movement | Barthel Index | 57.5 score on a scale | Standard Deviation 10.6 |
| Sham and no Arm Movement | Barthel Index | 50.0 score on a scale | Standard Deviation 0 |
Other Pre-specified
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.
Time frame: 3 months
Population: All participants with available measurement were included. fMRI Control Group no Intervention subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS and Occupational Therapy | Beck Depression Inventory | 3.2 units on a scale | Standard Deviation 2.9 |
| Sham and Occupational Therapy | Beck Depression Inventory | 5.0 units on a scale | Standard Deviation 4.5 |
| tDCS and no Arm Movement | Beck Depression Inventory | 5.50 units on a scale | Standard Deviation 3.54 |
| Sham and no Arm Movement | Beck Depression Inventory | 3.00 units on a scale | Standard Deviation 0 |
Other Pre-specified
fMRI Overactivation in Motor Cortex: Voxel Count and Intensity
Time frame: 3 months
Other Pre-specified
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).
Time frame: 3 months
Other Pre-specified
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.
Time frame: 3 months
Population: fMRI Control Group no Intervention subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS and Occupational Therapy | Mini Mental Status Scale | 24.7 score on a scale | Standard Deviation 6.6 |
| Sham and Occupational Therapy | Mini Mental Status Scale | 26.6 score on a scale | Standard Deviation 4.8 |
| tDCS and no Arm Movement | Mini Mental Status Scale | 27.3 score on a scale | Standard Deviation 3.8 |
| Sham and no Arm Movement | Mini Mental Status Scale | 30.0 score on a scale | Standard Deviation 0 |
Other Pre-specified
Motor Activity Log
Time frame: 3 months
Other Pre-specified
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.
Time frame: 3 months
Population: All available data from participants was included at the 3 months follow-up. fMRI Control Group no Intervention subgroup did not have clinical intervention or clinical outcome measures performed, their data was used for the fMRI and TMS component of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| tDCS and Occupational Therapy | NIHSS | 3.50 units on a scale | Standard Deviation 3.06 |
| Sham and Occupational Therapy | NIHSS | 1.45 units on a scale | Standard Deviation 1.57 |
| tDCS and no Arm Movement | NIHSS | 7.00 units on a scale | Standard Deviation 1 |
| Sham and no Arm Movement | NIHSS | 6.00 units on a scale | Standard Deviation 0 |
Other Pre-specified
Visual Analog Pain Scale
Time frame: during therapy