Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-24 @ 9:56 PM
NCT ID:
NCT03145532
Eligibility Criteria:
Inclusion Criteria:
* Age 6-17
* Participant and caregiver willing and able to provide informed consen/assent
* Diagnosis of hemiplegia
* Joint mobility: wrist extension, 20º, metacarpophalangeal and proximal interphalangeal joints 10º
Exclusion Criteria:
* Cognitive deficits that impede understanding of study protocol
* Current medical illness unrelated to CP
* Visual problems (uncorrected by glasses/contact lenses)
* High motor ability in affected arm Pre-intervention screening measures; Motor activity log, score \> 2.5 ( \> slight-to-moderate)
* Severe spasticity Pre-intervention screening measures; Modified Ashworth test, score \> 3 ( \> moderate)
* Lack of asymmetry in hand function
* Orthopedic surgery in affected arm within 2 years
* Dorsal root rhizotomy
* Botulinum toxin therapy in either upper extremity during last 2 months, or planned during study period
* Currently receiving intrathecal baclofen
* Seizure beyond age 2, use of anti-seizure medication, history of epilepsy (in self or first degree relatives), brain surgery, cranial metal implants, structural brain lesion, devices that may be affected by TMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
* True positive response on the Transcranial Magnetic Stimulation Safety Screen
* Current use of medications known to lower the seizure threshold
* Previous episode of neurocardiogenic syncopy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
17 Years
Study:
NCT03145532
Study Brief:
Protocol Section:
NCT03145532