NCT06128746

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
39mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Jan 2024Dec 2029

First Submitted

Initial submission to the registry

November 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 13, 2024

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

5.9 years

First QC Date

November 7, 2023

Last Update Submit

September 23, 2026

Conditions

CP (Cerebral Palsy)

Keywords

TMSCerebral palsySpasticity

Outcome Measures

Primary Outcomes (3)

  • Modified Ashworth Scale

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

    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

    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.

    Baseline, Day 10, 17 of intervention and 2 months post intervention

Secondary Outcomes (4)

  • Gross motor function measure

    Baseline, Day 10, 17 of intervention and 2 months post intervention

  • Pediatric Quality of Life Cerebral Palsy module

    Baseline, Day 10, 17 of intervention and 2 months post intervention

  • MRI Brain: fMRI and DKI

    Baseline, Day 10, 17 of intervention and 2 months post intervention

  • Purdue Pegboard Test

    Baseline, Day 10, 17 of intervention and 2 months post intervention

Study Arms (2)

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.

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.

Device: Sham Repetitive Transcranial Magnetic Stimulation

Interventions

Sham Repetitive Transcranial Magnetic StimulationDEVICE

Sham Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.

Sham rTMS group
Repetitive Transcranial Magnetic StimulationDEVICE

1 Hz rTMS treatment for 20 mins, followed by 1.5 hours of motor training.

Interventional rTMS group

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients aged between 4 years and 18 years
  • Diagnosis of hemiplegia
  • Upper limb spasticity ≥ 1
  • IQ ≥ 50

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Li Ka Shing Faculty of Medicine

Hong Kong, Hong Kong, 0000, Hong Kong

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Central Study Contacts

Winnie Wan Yee Tso, MBBS

CONTACT

+85222554295wytso@hku.hk

Chai Yin Charlie Fan, MPhil, OTR

CONTACT

+85222554375charliefan@connect.hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

November 7, 2023

First Posted

November 13, 2023

Study Start

January 13, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)