Comparing the Location of the Motor Cortex in Children Using Two Methods

Completed

• Conditions: Congenital Hemiparesis

• Registration Number: NCT02015338
• Lead Sponsor: University of Minnesota

Brief Summary

Hypothesis: In typically developing children (TDC), use of conventional EEG landmarks to determine the brain area that controls hand function will not differ from TMS-guided determination of individual motor hotspots. In children with hemiparesis, however, those two locations will diverge. The prediction is that TMS will best guide Transcranial Direct Current Stimulation (tDCS) interventions

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-12
• Study First Posted: 2013-12-19
• Study Start: 2014-02
• Primary Completion: 2015-09
• Study Completion: 2015-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-15
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the location of the motor cortex by two different means	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of distance in centimeters between the 10/20 EEG C3 or C4 location and the TMS-derived motor hotspot.	1 year	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.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States