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Completed

NCT Number: NCT02015338

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

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

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Determine the location of the motor cortex by two different means

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Comparing the Location of the Motor Cortex in Children Using Two Methods: EEG and TMS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 19, 2013
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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