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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorThe University of Hong Kong

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 4 years and 18 years

Diagnosis of hemiplegia

Upper limb spasticity ≥ 1

IQ ≥ 50

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation

    Device

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

  • Sham Repetitive Transcranial Magnetic Stimulation

    Device

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Interventional rTMS groupExperimental treatment 1 intervention
Group B: Sham rTMS groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Ashworth Scale

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

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

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

Time frame
Baseline, Day 10, 17 of intervention and 2 months post intervention
3

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.

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

Secondary outcomes

1

Gross motor function measure

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

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

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.

Time frame
Baseline, Day 10, 17 of intervention and 2 months post intervention
3

MRI Brain: fMRI and DKI

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

Time frame
Baseline, Day 10, 17 of intervention and 2 months post intervention
4

Purdue Pegboard Test

A standardized evaluation tool used to measure gross movements of hands, fingers, and arms, as well as fine fingertip dexterity.

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

Other outcomes

Sponsors and contacts

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