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

August 5, 2015 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Kuang-Lin Lin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • sham theta burst stimulation

What is the study measuring?

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.
Time Frame: baseline, post-treatment (after 3 days intervention), one months
Kinematic analysis for gait analysis.
baseline, post-treatment (after 3 days intervention), one months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Director: Kuang-Lin Lin, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

October 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (ESTIMATE)

August 10, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-0118A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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