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NCT Number: NCT06128746

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

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.

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Key information

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Li Ka Shing Faculty of Medicine

Hong Kong, 0000

Location status: Recruiting

Location contact

Charlie Fan, MPhil, OTR

CONTACT

[email protected]

+85222554375

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

1 Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training

Sham repetitive transcranial magnetic stimulation

Device

Sham Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training

Primary outcomes

  1. Modified Ashworth Scale

    Time frame: Day 10, 17 of intervention and 2 months post intervention

    Clinical measure of spasticity. Scores range from 0 to 4, with a higher score indicate worse in muscle tone

  2. The range of motion scores

    Time frame: Day 10, 17 of intervention and 2 months post intervention

    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

Secondary outcomes

  1. Zancolli scale

    Time frame: Day 10, 17 of intervention and 2 months post intervention

    Severity of forearm alignment. Scores range from 0 to 3 with a higher score indicate worse hand function

  2. House functional classification scale

    Time frame: Day 10, 17 of intervention and 2 months post intervention

    Rating of functional use of the impaired upper limb. Scale consists of nine grades from 0 (does not use) to 8 (full spontaneous use)

  3. Gross motor function measure

    Time frame: Day 10, 17 of intervention and 2 months post intervention

    Changes in motor function. A 4-point Likert scale with higher score indicates better motor function

  4. Assisting hand assessment

    Time frame: Day 10, 17 of intervention and 2 months post intervention

    Test of hand function

  5. Pediatric Quality of Life Cerebral Palsy module

    Time frame: Day 10, 17 of intervention and 2 months post intervention

    Quality of life measurement. Scores range from 0 to 100 with higher score indicate better quality of life.

  6. MRI Brain: fMRI and DKI

    Time frame: Day 10, 17 of intervention and 2 months post intervention

    Functional MRI and Diffusion Kurtosis Imaging measuring the brain microstructural changes and structural connectivity during the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Chai Yin Charlie Fan, MPhil, OTR

CONTACT

[email protected]

+85222554375

Winnie Wan Yee Tso, MBBS

CONTACT

[email protected]

+85222554295

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 13, 2023
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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