Acute Cerebrovascular Accident, Acute Stroke, Apoplexy, Cerebrovascular Accident, CVA, Stroke
Conditions
Keywords
Stroke, Ischemia, Infarction, Cerebrovascular Disorder, Central Nervous System Diseases, Brain Infarction, Brain Ischemia, Rehabilitation, Recovery, Neurorehabilitation, Plasticity
Brief summary
The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.
Interventions
DEVICEReal Transcranial Direct Current Stimulation
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
DEVICESham Transcranial Direct Current Stimulation
A sham current runs between two electrode positions and might affect the underlying brain tissue.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* First time clinical ischemic stroke or cerebrovascular accident * At least 5 months out from first ischemic stroke prior to study enrollment
Exclusion criteria
* More than 1 stroke (older strokes) * Significant pre-stroke disability * A terminal medical illness or disorder with survival of less than 1 year * Co-existent major neurological or psychiatric diseases (e.g., epilepsy) * Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents * Active participation in other stroke recovery trials testing interventions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment of Upper Extremity Motor Impairment | Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days | This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wolf-Motor-Function-Test | Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days | The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task, or similar as accurate. The average time in seconds is then log10 transformed. |
Countries
United States
Participant flow
Recruitment details
We advertised in local media, on Craig's list, and informed neurology colleagues and rehabilitation specialists about our trial. Stroke patients had to be at least 5 months out from their stroke and had to have a moderate impairment in their upper extremity weakness.
Pre-assignment details
There were no significant events that occurred after participant enrollment, prior to assignment.
Participants by arm
| Arm | Count |
|---|---|
| Real-tDCS + PT-OT Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.
Real Transcranial Direct Current Stimulation: A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue | 10 |
| Sham-tDCS + PT-OT Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.
Sham Transcranial Direct Current Stimulation: A sham current runs between two electrode positions and might affect the underlying brain tissue. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Sham-tDCS + PT-OT | Total | Real-tDCS + PT-OT |
|---|---|---|---|
| Age, Continuous | 55.8 years STANDARD_DEVIATION 12.9 | 58.7 years STANDARD_DEVIATION 13.8 | 61.7 years STANDARD_DEVIATION 14.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 15 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Fugl-Meyer Assessment of Upper Extremity Motor Impairment
This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.
Time frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-tDCS + PT-OT | Fugl-Meyer Assessment of Upper Extremity Motor Impairment | Pre-treatment (Baseline) | 38.2 units on a scale [0-66] | Standard Deviation 13.3 |
| Real-tDCS + PT-OT | Fugl-Meyer Assessment of Upper Extremity Motor Impairment | Post-treatment1 (3 days after 5 days of treatment) | 43.8 units on a scale [0-66] | Standard Deviation 12.3 |
| Real-tDCS + PT-OT | Fugl-Meyer Assessment of Upper Extremity Motor Impairment | Post-treatment2 (7 days after 5 days of treatment) | 44.3 units on a scale [0-66] | Standard Deviation 11.5 |
| Sham-tDCS + PT-OT | Fugl-Meyer Assessment of Upper Extremity Motor Impairment | Pre-treatment (Baseline) | 39.8 units on a scale [0-66] | Standard Deviation 11.5 |
| Sham-tDCS + PT-OT | Fugl-Meyer Assessment of Upper Extremity Motor Impairment | Post-treatment1 (3 days after 5 days of treatment) | 41.0 units on a scale [0-66] | Standard Deviation 11.8 |
| Sham-tDCS + PT-OT | Fugl-Meyer Assessment of Upper Extremity Motor Impairment | Post-treatment2 (7 days after 5 days of treatment) | 40.9 units on a scale [0-66] | Standard Deviation 11.7 |
Secondary
Wolf-Motor-Function-Test
The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task, or similar as accurate. The average time in seconds is then log10 transformed.
Time frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Real-tDCS + PT-OT | Wolf-Motor-Function-Test | Pre-treatment (baseline) | 0.87 units on a scale (log(sec)) | Standard Deviation 0.55 |
| Real-tDCS + PT-OT | Wolf-Motor-Function-Test | Post-treatment1 (3 days after 5 days of treatment) | 0.74 units on a scale (log(sec)) | Standard Deviation 0.49 |
| Real-tDCS + PT-OT | Wolf-Motor-Function-Test | Post-treatment2 (7 days after 5 days of treatment) | 0.73 units on a scale (log(sec)) | Standard Deviation 0.49 |
| Sham-tDCS + PT-OT | Wolf-Motor-Function-Test | Pre-treatment (baseline) | 0.83 units on a scale (log(sec)) | Standard Deviation 0.48 |
| Sham-tDCS + PT-OT | Wolf-Motor-Function-Test | Post-treatment1 (3 days after 5 days of treatment) | 0.79 units on a scale (log(sec)) | Standard Deviation 0.47 |
| Sham-tDCS + PT-OT | Wolf-Motor-Function-Test | Post-treatment2 (7 days after 5 days of treatment) | 0.78 units on a scale (log(sec)) | Standard Deviation 0.46 |