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

CP (Cerebral Palsy) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06128746
• Other study ID #: rTMSCPHKU
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2024
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: The University of Hong Kong
• Contact: Winnie Wan Yee Tso, MBBS
• Phone: +85222554295
• Email: wytso[@]hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• CP (Cerebral Palsy)
• Hemiplegia
• Muscle Spasticity
• Paralysis

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation
1 Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training
• Sham Repetitive Transcranial Magnetic Stimulation
Sham Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training

Locations

Country	Name	City	State
Hong Kong	Li Ka Shing Faculty of Medicine	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Assisting hand assessment	Test of hand function	Day 10, 17 of intervention and 2 months post intervention
Secondary	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
Secondary	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