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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
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 7 years and 18 years

Diagnosis of cerebral palsy with 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, 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

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
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
Day 10, 17 of intervention and 2 months post intervention

Secondary outcomes

1

Zancolli scale

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

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

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)

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

Gross motor function measure

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

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

Assisting hand assessment

Test of hand function

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

Other outcomes

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