About this trial
This RCT aims to investigate the effect of repetitive transcranial magnatic stimulation (rTMS) in treating children with hemiplegoc cerebral palsy. The study will measure any improvement in spasticity after using contra-lesional inhibitory rTMS follow by intensive limb training.
Participants will attend a 10-day rTMS treatment sessions, follow by intensive training of the impaired limb. They will also undergo MRI scans before and after the treatment to investiagte the underlying neurophysiological mechanisms that lead to changes clinically by using TMS as well as MR-DKI. Researchers will compare the intervention group and the sham group to see if rTMS could result in improvement of participants' spasticity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged between 4 years and 18 years
Diagnosis of hemiplegia
Upper limb spasticity ≥ 1
IQ ≥ 50
Disqualifiers
Any contra-indications to rTMS
Severe spasticity (score of 4 or more in Ashworth scale)
Uncontrollable epilepsy
History of Botulinum toxin A injection in previous 6 months
Trial design
Parallel
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation
Device1 Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.
Sham Repetitive Transcranial Magnetic Stimulation
DeviceSham Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.
Treatment groups
Trial outcomes
Primary outcomes
Modified Ashworth Scale
Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone
The range of motion scores
ROM of thumb adduction, wrist dorsal flexion and extension, and elbow dorsal flexion and extension. Patients' range of motion score will be compared to the normative values
The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)
The BOT-2 provides a comprehensive overview of fine and gross motor skills in children and young adults within school age-range.
Secondary outcomes
Gross motor function measure
Changes in motor function. A 4-point Likert scale with higher score indicates better motor function
Pediatric Quality of Life Cerebral Palsy module
Quality of life measurement. Scores range from 0 to 100 with higher score indicate better quality of life.
MRI Brain: fMRI and DKI
Functional MRI and Diffusion Kurtosis Imaging measuring the brain microstructural changes and structural connectivity during the intervention
Purdue Pegboard Test
A standardized evaluation tool used to measure gross movements of hands, fingers, and arms, as well as fine fingertip dexterity.
Sponsors and contacts
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