rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT

The University of Hong Kong (HKU)

Status: Enrolling

Conditions: CP (Cerebral Palsy)

Treatments: Device: Sham Repetitive Transcranial Magnetic Stimulation; Device: Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06128746

rTMSCPHKU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Interventional rTMS group

Experimental group

Description:

The intervention group will receive 1 Hz active rTMS during treatment, lasting for 20 minutes, follow up by 30 minutes of intensive limb training.

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

Sham rTMS group

Sham Comparator group

Description:

The sham group will not receive any Hz of rTMS during treatment, also lasting for 20 minutes with 30 minutes of intensive limb training afterwards.

Treatment:

Device: Sham Repetitive Transcranial Magnetic Stimulation