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

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

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.

Study Overview

• Status: Recruiting
• Conditions: CP (Cerebral Palsy)
• Intervention / Treatment: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Repetitive Transcranial Magnetic Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Winnie Wan Yee Tso, MBBS; Phone Number: +85222554295; Email: wytso@hku.hk
• Study Contact Backup: Name: Chai Yin Charlie Fan, MPhil, OTR; Phone Number: +85222554375; Email: charliefan@connect.hku.hk

Study Locations

• Hong Kong
  • Hong Kong
    • Hong Kong, Hong Kong, Hong Kong, 0000
      • Recruiting
      • Li Ka Shing Faculty of Medicine
      • Contact: Charlie Fan, MPhil, OTR; Phone Number: +85222554375; Email: charliefan@connect.hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional rTMS group; The intervention group will receive 1 Hz active rTMS during treatment, lasting for 20 minutes, follow up by 30 minutes of intensive limb training.	Device: Repetitive Transcranial Magnetic Stimulation; 1 Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training
Sham Comparator: Sham rTMS group; 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.	Device: Sham Repetitive Transcranial Magnetic Stimulation; Sham Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale	Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone	Day 10, 17 of intervention and 2 months post intervention
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	Day 10, 17 of intervention and 2 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zancolli scale	Severity of forearm alignment. Scores range from 0 to 3 with a higher score indicate worse hand function	Day 10, 17 of intervention and 2 months post intervention
House functional classification scale	Rating of functional use of the impaired upper limb. Scale consists of nine grades from 0 (does not use) to 8 (full spontaneous use)	Day 10, 17 of intervention and 2 months post intervention
Gross motor function measure	Changes in motor function. A 4-point Likert scale with higher score indicates better motor function	Day 10, 17 of intervention and 2 months post intervention
Assisting hand assessment	Test of hand function	Day 10, 17 of intervention and 2 months post intervention
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.	Day 10, 17 of intervention and 2 months post intervention
MRI Brain: fMRI and DKI	Functional MRI and Diffusion Kurtosis Imaging measuring the brain microstructural changes and structural connectivity during the intervention	Day 10, 17 of intervention and 2 months post intervention

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Cerebral palsy; Spasticity; TMS
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Spasticity; Cerebral Palsy; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: rTMSCPHKU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No