Clinical trial NCT06128746: rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Spasticity in Children With Hemiplegic Cerebral Palsy/ Hemiplegia Due to Acquired Brain Injury - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: CP (Cerebral Palsy)
Keywords: TMS
Cerebral palsy
Spasticity
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2023-11-13
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Cerebral palsy is the most common cause of lifelong physical disability in childhood, with an estimated prevalence of 1.5 per 1000 living biths for primary school-aged children. Spasticity is the most common symptoms in children with cerebral palsy, leading to muscle weakness affecting gross motor functions and causing complications such as pain, contracture and subluzation which will lead to inability to perform activity-based training and subsequently lead to further muscle weakness. Standard therapy with regular physiotherapy and occupational therapy are essential but time-consuming and the effects might not last for longer duration. Patients or caregivers decline medications because of side effects drowsiness while other interventions such as intra-thecal baclofen pump, rhizotomy or surgery are invasive.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has the ability to modulate excitation of the motor cortex area of the brain. There were past studies suggesting that using contralesional inhibitory rTMS was safe and feasible for patients with paediatric subcortical stroke and seemed to improve hand function in patients with hemiparesis. However, limited studies have been published on the effects of rTMS on improving spasticity in children with cerebral palsy. Hence, the objective of this study is to use low-frequency rTMS to the contra-lesional hemisphere in children with hemiplegic cerebral palsy to investigate if rTMS follow by intensive limb training would improve spasiticity of these children and whether the improvement can be sustained for a longer time. The underlying mechanisms that lead to the changes clinically will also be investigated by TMS and MRI.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 7 years and 18 years
* Diagnosis of cerebral palsy with hemiplegia
* Upper limb spasticity ≥ 1
* IQ ≥ 50

Exclusion Criteria:

* 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
* Upper limb casting in previous 6 months

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: Day 10, 17 of intervention and 2 months post intervention
measure: The range of motion scores
timeFrame: Day 10, 17 of intervention and 2 months post intervention
Secondary outcomes:
measure: Zancolli scale
timeFrame: Day 10, 17 of intervention and 2 months post intervention
measure: House functional classification scale
timeFrame: Day 10, 17 of intervention and 2 months post intervention
measure: Gross motor function measure
timeFrame: Day 10, 17 of intervention and 2 months post intervention
measure: Assisting hand assessment
timeFrame: Day 10, 17 of intervention and 2 months post intervention
measure: Pediatric Quality of Life Cerebral Palsy module
timeFrame: Day 10, 17 of intervention and 2 months post intervention
measure: MRI Brain: fMRI and DKI
timeFrame: Day 10, 17 of intervention and 2 months post intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Li Ka Shing Faculty of Medicine
Study officials:
References: