- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02015338
Comparing the Location of the Motor Cortex in Children Using Two Methods
Comparing the Location of the Motor Cortex in Children Using Two Methods: EEG and TMS
Study Overview
Status
Conditions
Detailed Description
Congenital hemiparesis, mainly due to stroke, affects approximately 25% of children with cerebral palsy. Noninvasive brain stimulation has emerged to influence improvements in hand function specifically in children with congenital hemiparesis due to stroke.
The use of one type of noninvasive brain stimulation, Transcranial Direct Current Stimulation (tDCS), in conjunction with rehabilitation training intervention for a child with hemiparesis proposes a synergistic approach to improving hand function. Application of electrodes over certain targeted areas are placed with the intent to stimulate and influence neuronal activity.
Our preliminary evidence suggests that in children with hemiparesis due to stroke, the area for placement is variable as noted by electroencephalogram (EEG) and Transcranial Magnetic Stimulation (TMS) measurement methods, influencing the site location of optimal stimulation for tDCS.
Due to this variation, the optimal site of stimulation warrants investigation for the optimal placement of tDCS.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Typically Developing Children:
- Ages 8-17
Children with congenital hemiparesis due to hemispheric stroke:
- Ages 8-17
- Equal of greater than 10 degrees of active motion at the metacarpophalangeal joint
- No evidence of seizure activity within the last 2 years.
Exclusion Criteria:
Typically Developing Children:
- neurologic disorders
- indwelling metal
- pregnancy
- history of seizures
Children with hemiparesis:
- Metabolic disorders
- Neoplasm
- Epilepsy
- Disorders of cellular migration and proliferation
- Expressive aphasia
- Pregnancy
- Indwelling metal
- Botulinum toxin or phenol intramuscular block within the one-month preceding TMS application.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Typically Developing Children
Children with typical development (e.g.
no presence of neurological disorders or diagnoses)
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Children with Hemiparesis
Children diagnosed with Hemiparesis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the location of the motor cortex by two different means
Time Frame: 1 year
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Determine the location of the motor cortex through two means: 1) The international 10/20 EEG system of measurement and 2) Transcranial Magnetic Stimulation (TMS) testing of cortical excitability in typically developing children and children with hemiparesis.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of distance in centimeters between the 10/20 EEG C3 or C4 location and the TMS-derived motor hotspot.
Time Frame: 1 year
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Compare the two locations (in each hemisphere) determined by 10/20 EEG system and Transcranial Magnetic Stimulation (TMS) testing and measure in centimeters differences between the two locations.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bernadette T Gillick, PhD, MSPT, University of Minnesota
Publications and helpful links
General Publications
- Rich TL, Menk JS, Rudser KD, Chen M, Meekins GD, Pena E, Feyma T, Bawroski K, Bush C, Gillick BT. Determining Electrode Placement for Transcranial Direct Current Stimulation: A Comparison of EEG- Versus TMS-Guided Methods. Clin EEG Neurosci. 2017 Nov;48(6):367-375. doi: 10.1177/1550059417709177. Epub 2017 May 22.
- Rich TL, Menk JS, Rudser KD, Feyma T, Gillick BT. Less-Affected Hand Function in Children With Hemiparetic Unilateral Cerebral Palsy: A Comparison Study With Typically Developing Peers. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):965-976. doi: 10.1177/1545968317739997. Epub 2017 Nov 12.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1311M45303
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.
Clinical Trials on Congenital Hemiparesis
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Taipei Medical University WanFang HospitalWithdrawnPoststroke/CVA HemiparesisTaiwan
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NYU Langone HealthCompleted
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