Stroke
Conditions
Keywords
Stroke, chronic ischemic stroke, cerebrovascular accident (CVA), ischaemic stroke
Brief summary
Transcranial magnetic stimulation for post-stroke upper-body motor deficits.
Detailed description
This study uses transcranial magnetic stimulation (magnetic pulses delivered through a specially designed cap worn on the head aimed at specific motor areas of the brain (brain areas responsible for the body's physical movements) to test whether upper-body motor function can be improved. This is a double-blind study where half of participants will receive active transcranial stimulation and the other half of the participants will receive no transcranial magnetic stimulation; all participants will wear the cap. Participants and some members of the research team will not know who received active magnetic brain stimulation.
Interventions
DEVICErepetitive Transcranial Magnetic Stimulation -On
Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
DEVICErepetitive Transcranial Magnetic Stimulation -Off
Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
Sponsors
The Methodist Hospital Research Institute
Seraya Medical
David Chiu, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double-blind, only the care provider is aware of active treatment assignment.
Intervention model description
Active repetitive transcranial magnetic stimulation administered through cap worn by patient under healthcare provider.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-80 years; * Clinical diagnosis of chronic ischemic stroke recovering for more than 3 months with unilateral motor deficits of arm and leg, or arm alone; --
Exclusion criteria
* History of seizure; * Epileptogenic activity (indicative of increased risk of seizures) on EEG; * Any active unstable medical condition; * Pregnancy; * Schizophrenia, bipolar disorder, alcoholism, or substance abuse; * Medications which in the investigator's clinical judgment significantly lower the seizure threshold; * Presence of metal or electronic implants in the head (or any in the body that preclude MRI) , including pacemakers, defibrillators, aneurysm clips, neuro-stimulators, cochlear implants, metal in the eyes, etc.; * Any changes in medications prescribed for the treatment of stroke impairment within six weeks prior to inclusion in the study or at any time during the study. * Botulinum toxin use within two months prior to the screening visit or any planned use of botulinum toxin during the study * Changes in NIHSS and motor assessment scores between Visit 1 and Visit 2 indicating that the patient's impairment is not stable. The following cutoffs, based on research establishing Clinically Important Differences, will be used for this determination: * National Institutes of Health Stroke Scale: A change in total score of more than 2 points in either direction, or a change in the motor extremity score of more than 1 point in either direction. * Fugl-Meyer Assessment of Sensorimotor Impairment: A change of more than 5 points in either direction on the upper-extremity motor score for the affected arm. * Action Research Arm Test: A change of more than 5 points in either direction on the ARAT score for the affected arm. * Any condition that precludes a high quality brain MRI scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Brain Activation | One business day before treatment begins, one business day after treatment ends, up to 5 weeks | Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ARAT (Action Research Arm Test) | One business day before treatment begins, one business day after treatment ends up to 5 weeks | Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome |
| Hand Dynamometer | One business day before treatment begins, one business day after treatment ends up to 5 weeks | Change in grip strength The higher the number represents better outcome |
| Fugl-Meyer Motor Arm Score | One business day before treatment begins, one business day after treatment ends up to 5 weeks | Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome |
| TUG (Timed Up and Go Test) | One business day before treatment begins, one business day after treatment ends up to 5 weeks | Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome. |
| National Institutes of Health Stroke Scale (NIHSS) | One business day before treatment begins, one business day after treatment ends up to 5 weeks | Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome |
| Pinch Dynamometer Score | One business day before treatment begins, one business day after treatment ends up to 5 weeks | Change in pinch strength. The higher the number, the better the outcome. |
Countries
United States
Participant flow
Recruitment details
38 patients were screened 7 were screen fails. 2 withdrawn. 14 treated-Active, 15 treated-placebo.
Participants by arm
| Arm | Count |
|---|---|
| Repetitive Transcranial Magnetic Stimulation -On Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap delivering magnetic stimulation to part of the brain.
repetitive Transcranial Magnetic Stimulation -On: Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain | 16 |
| Repetitive Transcranial Magnetic Stimulation -Off Participants wear the repetitive transcranial magnetic stimulation (rTMS) cap that does NOT delivery any magnetic stimulation to the brain.
repetitive Transcranial Magnetic Stimulation -Off: Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment. | 15 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Repetitive Transcranial Magnetic Stimulation -On | Total | Repetitive Transcranial Magnetic Stimulation -Off |
|---|---|---|---|
| Action Research Arm Test (ARAT) | 29 score on a scale | 14.0 score on a scale | 6 score on a scale |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 16 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 13 Participants | 7 Participants |
| Age, Continuous | 65.4 years | 65.8 years | 66.3 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 26 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fugl-Meyer motor arm score | 43 score on a scale | 37.0 score on a scale | 25 score on a scale |
| Gait velocity on Timed Up and Go Test | 1.32 feet per second | 1.45 feet per second | 1.45 feet per second |
| Hand Grip Strength | 19.7 Pounds | 21.8 Pounds | 30.6 Pounds |
| National Institutes of Health Stroke Scale (NIHSS) | 3 score on a scale | 3.0 score on a scale | 3 score on a scale |
| Pinch Strength | 6.5 Pounds | 4.7 Pounds | 3.83 Pounds |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 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 | 25 Participants | 15 Participants |
| Region of Enrollment United States | 14 participants | 29 participants | 15 participants |
| Sex: Female, Male Female | 6 Participants | 15 Participants | 9 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 15 |
| other Total, other adverse events | 1 / 16 | 3 / 15 |
| serious Total, serious adverse events | 2 / 16 | 2 / 15 |
Outcome results
Primary
Changes in Brain Activation
Change in number of active voxels in the cortical areas surrounding the lesion on functional MRI
Time frame: One business day before treatment begins, one business day after treatment ends, up to 5 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation -On | Changes in Brain Activation | 48.5 voxels |
| Repetitive Transcranial Magnetic Stimulation -Off | Changes in Brain Activation | -30 voxels |
Secondary
ARAT (Action Research Arm Test)
Change in arm and hand motor function Total score range is 0-57 with the higher number representing a better outcome
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
Population: Stroke patients greater than 3 months from qualifying stroke date
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation -On | ARAT (Action Research Arm Test) | 0 score on a scale |
| Repetitive Transcranial Magnetic Stimulation -Off | ARAT (Action Research Arm Test) | 0 score on a scale |
Secondary
Fugl-Meyer Motor Arm Score
Change in arm motor function Total score range is 0-66 with the higher number representing a better outcome
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation -On | Fugl-Meyer Motor Arm Score | 2.5 score on a scale |
| Repetitive Transcranial Magnetic Stimulation -Off | Fugl-Meyer Motor Arm Score | 2.0 score on a scale |
Secondary
Hand Dynamometer
Change in grip strength The higher the number represents better outcome
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation -On | Hand Dynamometer | 1.8 pounds |
| Repetitive Transcranial Magnetic Stimulation -Off | Hand Dynamometer | 0 pounds |
Secondary
National Institutes of Health Stroke Scale (NIHSS)
Change in National Institutes of Health Stroke Scale (NIHSS) Total score range is 0-42 with the lower number representing a better outcome
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation -On | National Institutes of Health Stroke Scale (NIHSS) | 0 score on a scale |
| Repetitive Transcranial Magnetic Stimulation -Off | National Institutes of Health Stroke Scale (NIHSS) | 0 score on a scale |
Secondary
Pinch Dynamometer Score
Change in pinch strength. The higher the number, the better the outcome.
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation -On | Pinch Dynamometer Score | .17 pounds |
| Repetitive Transcranial Magnetic Stimulation -Off | Pinch Dynamometer Score | .33 pounds |
Secondary
TUG (Timed Up and Go Test)
Change in gait velocity on Timed Up and Go Test. The lower the time recorded, the better the outcome.
Time frame: One business day before treatment begins, one business day after treatment ends up to 5 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation -On | TUG (Timed Up and Go Test) | .04 feet per second |
| Repetitive Transcranial Magnetic Stimulation -Off | TUG (Timed Up and Go Test) | 0 feet per second |