Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation

Study Overview
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Brief Summary
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Transcranial magnetic stimulation (TMS) has opened new potential avenues for the treatment of neuropsychiatric diseases via the effects of modulation on neuroplasticity. Repetitive TMS (rTMS) is a non-invasive method of stimulation neural pathways in the brain of conscious subjects through the intact scalp. The investigators hypothesize that excitatory rTMS applied over the motor cortex would increase motor cortex activity and result in an increase in the inhibitory input through the corticospinal tract to the spinal cord, thus reducing alpha neuron hyperactivity and consequently clinical spasticity. In this study, the investigators will apply the stimulation on the legs motor cortex area, which can cover supplemental motor area (SMA). Therefore, not only the spasticity, but also the motor control of legs both can be modulated by stimulation. Theta burst stimulation is a condition of rTMS which was designed by the co-investigator. It has controllable, consistent, long-lasting, and powerful effects on motor cortex physiology and behavior. The investigators therefore design this protocol using theta burst stimulation on the motor cortex of the patients of cerebral palsy. The investigators expect that there would be an effect on the reduction of spasticity after rTMS on the brain of children with CP, thus improving the motor control of legs.

Detailed Description
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In this study, the investigators design 3 steps to find out the optimal condition of rTMS for the treatment and managing of motor disability of CP. The first is to find out the optimal intensity of rTMS. The second is to find out the optimal duration of rTMS and long term effects. The third is to compare the effectiveness of botulinum toxin injection, rTMS, and combined therapy (botulinum toxin injection and rTMS) for children with CP.

Official Title
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Modulating and Managing the Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Other: high intensity iTBS
* Other: low intensity iTBS
* Other: sham iTBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of mild to moderate CP with spastic diplegia or hemiplegia according to clinical criteria age 7-20 years no use of botulinum toxin in the past 4 months no significant perceptual or communication disturbances no other peripheral or central nervous system dysfunction no active inflammatory or pathologic changes in lower limb joints during the previous 6 months no active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection no active problems of epilepsy and EEG without epileptiform discharge ability to walk 20m without walking aids, such as a cane, quadricane or walker Exclusion Criteria: Metabolic disorders, such as inborn error of metabolism, electrolyte, and endocrine disorders. Active infectious disease, such as meningitis and encephalitis. Patients with active medical problems, such as pneumonia, upper gastrointestinal bleeding, or urinary tract infection. Poor compliance or intolerance for the TMS therapy Subjects with metallic implants or pregnancy. EEG show epileptiform discharge

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high intensity iTBS<br>high intensity iTBS: 100% of active motor threshold for 3 days. | Other: high intensity iTBS<br>* In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (high intensity , 100% of active motor threshold) TBS for 3 days.<br>* Other names: high intensity intermittent theta burst stimulation;|
| Experimental: low intensity iTBS<br>low intensity iTBS: 80% of active motor threshold for 3 days. | Other: low intensity iTBS<br>* In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low intensity, 80% of active motor threshold) TBS for 3 days.<br>* Other names: low intensity intermittent theta burst stimulation;|
| Sham Comparator: sham iTBS<br>sham iTBS for 3 days. | Other: sham iTBS<br>* In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment.<br>* Other names: sham theta burst stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Kinematic analysis in post-treatment (after 3 days intervention) and one months follow up. | Kinematic analysis for gait analysis. | baseline, post-treatment (after 3 days intervention), one months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral palsy, Transcranial magnetic stimulation