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

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ClinicalTrials.gov Identifier: NCT02518867
Recruitment Status : Unknown
Verified July 2015 by Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Other: high intensity iTBS Other: low intensity iTBS Other: sham iTBS Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulating and Managing the Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation
Study Start Date : March 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: high intensity iTBS
high intensity iTBS: 100% of active motor threshold for 3 days.
Other: high intensity 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.
Other Name: high intensity intermittent theta burst stimulation

Experimental: low intensity iTBS
low intensity iTBS: 80% of active motor threshold for 3 days.
Other: low intensity 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 (low intensity, 80% of active motor threshold) TBS for 3 days.
Other Name: low intensity intermittent theta burst stimulation

Sham Comparator: sham iTBS
sham iTBS for 3 days.
Other: sham iTBS
In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment.
Other Name: sham theta burst stimulation




Primary Outcome Measures :
  1. Change from baseline of Kinematic analysis in post-treatment (after 3 days intervention) and one months follow up. [ Time Frame: baseline, post-treatment (after 3 days intervention), one months ]
    Kinematic analysis for gait analysis.



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Ages Eligible for Study:   7 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518867


Contacts
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Contact: Kuang-Lin Lin +886-3-3281200 ext 8200 lincgh@cgmh.org.tw

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Kuang-Lin Lin    +886-3-3281200 ext 8200    lincgh@cgmh.org.tw   
Principal Investigator: Kuang-Lin Lin         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Director: Kuang-Lin Lin Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02518867    
Other Study ID Numbers: 98-0118A
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 10, 2015
Last Verified: July 2015
Keywords provided by Chang Gung Memorial Hospital:
Cerebral palsy
Transcranial magnetic stimulation
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases