rTMS Treatment of Spasticity in Children With Cerebral Palsy/ Hemiplegia Due to ABI - a RCT
NCT ID: NCT06128746
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-01-13
2025-07-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional rTMS group
The intervention group will receive 1 Hz active rTMS during treatment, lasting for 20 minutes, follow up by 30 minutes of intensive limb training.
Repetitive Transcranial Magnetic Stimulation
1 Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training
Sham rTMS group
The sham group will not receive any Hz of rTMS during treatment, also lasting for 20 minutes with 30 minutes of intensive limb training afterwards.
Sham Repetitive Transcranial Magnetic Stimulation
Sham Hz rTMS treatment for 20 mins, follow by 30 mins intensive limb training
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cerebral palsy with hemiplegia
* Upper limb spasticity ≥ 1
* IQ ≥ 50
Exclusion Criteria
* 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
7 Years
18 Years
ALL
No
Sponsors
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The University of Hong Kong
OTHER
Responsible Party
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Winnie Wan Yee Tso (Dr)
Clinical Assistant Professor
Locations
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Li Ka Shing Faculty of Medicine
Hong Kong, , Hong Kong
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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rTMSCPHKU
Identifier Type: -
Identifier Source: org_study_id
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