Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation
Modulating and Managing the Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation
1 other identifier
interventional
90
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
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 Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
August 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedAugust 10, 2015
July 1, 2015
2.6 years
February 10, 2015
August 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
high intensity iTBS
EXPERIMENTALhigh intensity iTBS: 100% of active motor threshold for 3 days.
low intensity iTBS
EXPERIMENTALlow intensity iTBS: 80% of active motor threshold for 3 days.
sham iTBS
SHAM COMPARATORsham iTBS for 3 days.
Interventions
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.
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.
In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan District, 333, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kuang-Lin Lin
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
August 10, 2015
Study Start
March 1, 2013
Primary Completion
October 1, 2015
Study Completion
December 1, 2015
Last Updated
August 10, 2015
Record last verified: 2015-07