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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-1533 | Other Identifier | Cincinnati Children's Hospital Medical Center |
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Study was terminated due to low recruitment.
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The purpose of this study is to determine whether Repetitive Transcranial Magnetic Stimulation (rTMS) can augment occupational therapy in improving motor function in children (10 years of age or older) and young adults (< 21 years of age) with chronic hemiparesis from either stroke or cerebral palsy.
RTMS is a noninvasive technology that can induce changes in brain function that may lead to functional improvement in people with hemiparesis. This is a randomized, double-blinded, sham-controlled rTMS study in conjunction with intensive daily occupational therapy (OT) for 2 weeks to improve motor function in hemiparetic patients. Participants will be followed for at least 12 weeks after rTMS to detect any clinical change. The sham group participants will be offered an open-label active rTMS treatment plus OT after the 12 week assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active rTMS | Active Comparator | Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. |
|
| Sham rTMS | Sham Comparator | Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the "Melbourne Assessment of Unilateral Upper Limb Function" | Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in the "Melbourne Assessment of Unilateral Upper Limb Function" | Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 7 days after rTMS/OT | |
| Change in the "Melbourne Assessment of Unilateral Upper Limb Function" | Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 12 weeks after rTMS/OT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steve W Wu, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active rTMS | Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study. Occupational Therapy |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sham Repetitive Transcranial Magnetic Stimulation | Device |
|
| Occupational Therapy | Other |
|
| Sham rTMS |
Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Sham Repetitive Transcranial Magnetic Stimulation Occupational Therapy |
| COMPLETED |
|
| NOT COMPLETED |
|
After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active rTMS | Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study. Occupational Therapy |
| BG001 | Sham rTMS | Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Sham Repetitive Transcranial Magnetic Stimulation Occupational Therapy |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| ||||||||||||||||||||||
| Sex: Female, Male |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the "Melbourne Assessment of Unilateral Upper Limb Function" | After signing consent forms, two separate participants did not proceed with the study. The study was then terminated. | Posted | Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT |
|
| |||||||||||||||||||||||
| Other Pre-specified | Change in the "Melbourne Assessment of Unilateral Upper Limb Function" | After signing consent forms, two separate participants did not proceed with the study. The study was then terminated. | Posted | Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 7 days after rTMS/OT |
|
| |||||||||||||||||||||||
| Other Pre-specified | Change in the "Melbourne Assessment of Unilateral Upper Limb Function" | After signing consent forms, two separate participants did not proceed with the study. The study was then terminated. | Posted | Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 12 weeks after rTMS/OT |
|
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After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active rTMS | Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study. Occupational Therapy | 0 | 0 | 0 | 0 | ||
| EG001 | Sham rTMS | Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Sham Repetitive Transcranial Magnetic Stimulation Occupational Therapy | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Wu, MD | Cincinnati Children's Hospital Medical Center | 513-636-4222 | steve.wu@cchmc.org |
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| D009788 | Occupational Therapy |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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