An interventional study of high intensity iTBS and low intensity iTBS in Cerebral Palsy, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 7 Years to 20 Years. Per ClinicalTrials.gov, last updated 2015-08-10.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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.
750 studies on the registry are indexed under Paralysis; 133 are open to participants now.
This study's planned enrollment of 90 is above the median of 30 across 537 interventional studies indexed under Paralysis.
Browse Paralysis studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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Exclusion Criteria:
high intensity iTBS: 100% of active motor threshold for 3 days.
Other: high intensity iTBS
low intensity iTBS: 80% of active motor threshold for 3 days.
Other: low intensity iTBS
sham iTBS for 3 days.
Other: sham iTBS
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.
Also known as: high intensity intermittent theta burst stimulation
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.
Also known as: low intensity intermittent theta burst stimulation
In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment.
Also known as: sham theta burst stimulation
Change from baseline of Kinematic analysis in post-treatment (after 3 days intervention) and one months follow up.
Kinematic analysis for gait analysis.
Time frame: baseline, post-treatment (after 3 days intervention), one months
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Chang Gung Memorial Hospital