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

Primary Purpose

Cerebral Palsy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
high intensity iTBS
low intensity iTBS
sham iTBS
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral palsy, Transcranial magnetic stimulation

Eligibility Criteria

7 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

high intensity iTBS

low intensity iTBS

sham iTBS

Arm Description

high intensity iTBS: 100% of active motor threshold for 3 days.

low intensity iTBS: 80% of active motor threshold for 3 days.

sham iTBS for 3 days.

Outcomes

Primary Outcome Measures

Change from baseline of Kinematic analysis in post-treatment (after 3 days intervention) and one months follow up.
Kinematic analysis for gait analysis.

Secondary Outcome Measures

Full Information

First Posted
February 10, 2015
Last Updated
August 5, 2015
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02518867
Brief Title
Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation
Official Title
Modulating and Managing the Motor Disability of Children With Cerebral Palsy Using Motor Transcranial Magnetic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral palsy, Transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high intensity iTBS
Arm Type
Experimental
Arm Description
high intensity iTBS: 100% of active motor threshold for 3 days.
Arm Title
low intensity iTBS
Arm Type
Experimental
Arm Description
low intensity iTBS: 80% of active motor threshold for 3 days.
Arm Title
sham iTBS
Arm Type
Sham Comparator
Arm Description
sham iTBS for 3 days.
Intervention Type
Other
Intervention Name(s)
high intensity iTBS
Other Intervention Name(s)
high intensity intermittent theta burst stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
low intensity iTBS
Other Intervention Name(s)
low intensity intermittent theta burst stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
sham iTBS
Other Intervention Name(s)
sham theta burst stimulation
Intervention Description
In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment.
Primary Outcome Measure Information:
Title
Change from baseline of Kinematic analysis in post-treatment (after 3 days intervention) and one months follow up.
Description
Kinematic analysis for gait analysis.
Time Frame
baseline, post-treatment (after 3 days intervention), one months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuang-Lin Lin
Phone
+886-3-3281200
Ext
8200
Email
lincgh@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuang-Lin Lin
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuang-Lin Lin
Phone
+886-3-3281200
Ext
8200
Email
lincgh@cgmh.org.tw
First Name & Middle Initial & Last Name & Degree
Kuang-Lin Lin

12. IPD Sharing Statement

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

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