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The central objective of this application is to explore the neural substrate of personalized tDCS (ptDCS) and to determine whether the paradigm for each stroke patient can predict the amount of sustained clinical improvement through increased connectivity as measured by a biomarker of plasticity.
This is a randomized, sham controlled double masked parallel group study with optional crossover of chronic (>3mo from stroke onset) ischemic or hemorrhagic stroke patients to test the effect of ptDCS on a cerebral connectivity biomarker of plasticity during stimulation and after 10 treatment of up to 2 mA ptDCS. PtDCS will be performed during the first 20 minutes of occupational therapy targeting the weaker arm compared to sham. Patients will have the option to cross over after the completion of 1-month follow-up and will complete the same procedures with real tDCS if they were in the sham group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized Transcranial direct current stimulation (ptDCS) | Experimental | TDCS is a noninvasive form of cortical stimulation that uses a battery-powered device. [67] Weak current (0.5-2 mA) will be delivered for up to 20 minutes through surface electrodes which will be positioned using the montage identified as the best in the individual stroke patient during our initial testing session during OT targeting the affected arm. |
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| Sham tDCS | Placebo Comparator | Same OT procedure and montage as with the active stimulation but the current will be increased then decreased ramp-like and switched off after 20 seconds instead of the 20 minutes to elicit the same cutaneous sensation as the other stimulation conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) with OT | Device | Weak direct current (0.5-2 mA) will be delivered for up to 20 minutes through surface electrodes which will be positioned using the ptDCS montage. The current will be increased and decreased ramp-like at the beginning and end of the 20-minute stimulation to lessen the itchy/numb skin sensation and decrease the likelihood of an innocuous phosphene-like visual phenomenon. The stimulation will be delivered during the first 20 minutes of occupational therapy targeted to the more affected upper extremity. |
| Measure | Description | Time Frame |
|---|---|---|
| fMRI functional connectivity biomarker | Task activation, resting state functional connectivity | baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Wolf Motor Function Test | A time-based measurement of upper extremity function of 17 tasks. Shorter performance time is better. | 4 weeks |
| Fugl-Meyer assessment | The upper extremity component of Fugl-Meyer test (uFM) is a widely used cumulative numeric rating tool that assesses motor impairment. Range is 0-66, higher score is better. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neha Sudarshan, MD | Contact | 9082277275 | nsudarshan@houstonmethodist.org | |
| Timea Hodics, MD | Contact | 281-381-1728 | tmhodics@houstonmethodist.org |
| Name | Affiliation | Role |
|---|---|---|
| Timea Hodics, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020300 | Intracranial Hemorrhages |
| D000083242 | Ischemic Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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|
| Sham tDCS with OT | Device | Same procedure and montage as with the active stimulation but the current will be increased then decreased ramp-like and switched off after 20 seconds instead of the 20 minutes to elicit the same cutaneous sensation as the other stimulation conditions. [69] This short length of stimulation is documented to elicit sensations comparable to those of real stimulation. With this procedure, subjects were unable to differentiate between tDCS and sham stimulation in our and other previous studies. |
|
| 4 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |