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

Congenital Hemiparesis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02015338
• Other study ID #: 1311M45303
• Status: Completed
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2019
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Hemiparesis
• Paresis

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (2)

Rich TL, Menk JS, Rudser KD, Chen M, Meekins GD, Peña 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the location of the motor cortex by two different means	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.	1 year
Secondary	Measurement of distance in centimeters between the 10/20 EEG C3 or C4 location and the TMS-derived motor hotspot.	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