CP (Cerebral Palsy)NCT06128746
rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT
A study testing Repetitive Transcranial Magnetic Stimulation in people with CP (Cerebral Palsy), run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- CP (Cerebral Palsy)
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 Jan 2024to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged between 4 years and 18 years
- Diagnosis of hemiplegia
- Upper limb spasticity ≥ 1
- IQ ≥ 50
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Li Ka Shing Faculty of Medicine
Hong Kong, Hong Kong, 0000
Charlie Fan, MPhil, OTR, +85222554375, charliefan@connect.hku.hk
About this study
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
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.
Read the 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.
- Conditions
- CP (Cerebral Palsy)
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation
- Keywords
- TMS, Cerebral palsy, Spasticity
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
1 Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.
Sham Repetitive Transcranial Magnetic StimulationDevice
Sham Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.
| Study group | Role | What they receive |
|---|---|---|
| Interventional rTMS group | Experimental | The intervention group will receive 1 Hz active rTMS during treatment, lasting for 20 minutes, follow up by 1.5 hours of motor training. Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| Sham rTMS group | Sham comparator | The sham group will not receive any Hz of rTMS during treatment, also lasting for 20 minutes with 1.5 hours of motor training. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone
Measured: Baseline, 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
Measured: Baseline, Day 10, 17 of intervention and 2 months post intervention
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.
Measured: Baseline, Day 10, 17 of intervention and 2 months post intervention
Secondary outcomes (4)
Gross motor function measure
Changes in motor function. A 4-point Likert scale with higher score indicates better motor function
Measured: Baseline, 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.
Measured: Baseline, 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
Measured: Baseline, Day 10, 17 of intervention and 2 months post intervention
Purdue Pegboard Test
A standardized evaluation tool used to measure gross movements of hands, fingers, and arms, as well as fine fingertip dexterity.
Measured: Baseline, Day 10, 17 of intervention and 2 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start13 Jan 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CP (Cerebral Palsy)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winnie Wan Yee Tso (Dr), The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128746
- Sponsor's protocol ID
- rTMSCPHKU
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No