Clinical trial NCT02015338: Comparing the Location of the Motor Cortex in Children Using Two Methods
Official title: Comparing the Location of the Motor Cortex in Children Using Two Methods: EEG and TMS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Hemiparesis
Keywords: Hemiparesis
Cerebral Palsy
Congenital Stroke
Congenital Infarct
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 47
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children with congenital hemiparesis and typically developing children

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the location of the motor cortex by two different means
timeFrame: 1 year
Secondary outcomes:
measure: Measurement of distance in centimeters between the 10/20 EEG C3 or C4 location and the TMS-derived motor hotspot.
timeFrame: 1 year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Bernadette T Gillick, PhD, MSPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.