Cerebral Palsy, Chronic Hemiparesis, Pediatric Stroke
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation
We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
DEVICESham Repetitive Transcranial Magnetic Stimulation
OTHEROccupational Therapy
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 10 years; \< 21 years * Hemiparesis * Manual Ability Classification System (MACS) level I through IV * Provision of written informed consent by the patient and/or guardian, including understanding that insurance may be billed for the occupational therapy * Written assent form signed by participants younger than 18 years of age
Exclusion criteria
* Underlying degenerative or metabolic disorder or supervening medical illness * Severe depression or other psychiatric disorder * Any participant who is pregnant * Any contraindication to TMS (i.e., intracranial metal implants, shunts, ports, pacemaker, baclofen pumps) * Any changes or addition of neuropsychiatric medications within 1 month of starting the study or during course of the study (if applicable) * Any botulinum toxin (Botox, Myobloc) or phenol injection within the last 3 months prior to the study or during the course of the study (if applicable) * Any upper extremity surgery within the last 6 months prior to the study or scheduled during the course of the study (if applicable)
Design outcomes
Primary
| Measure | 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 |
Other
| Measure | 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 |
Countries
United States
Participant flow
Pre-assignment details
After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| 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 |
| Total | 0 |
Baseline characteristics
| Characteristic | Total |
|---|---|
| Sex: Female, Male Female | 0 |
| Sex: Female, Male Male | 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in the Melbourne Assessment of Unilateral Upper Limb Function
Time frame: Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 3 days after rTMS/OT
Population: After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.
Other Pre-specified
Change in the Melbourne Assessment of Unilateral Upper Limb Function
Time frame: Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 7 days after rTMS/OT
Population: After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.
Other Pre-specified
Change in the Melbourne Assessment of Unilateral Upper Limb Function
Time frame: Change in the Melbourne Assessment of Unilateral Upper Limb Function between baseline and 12 weeks after rTMS/OT
Population: After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.