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

NCT ID: NCT02015338

Last Updated: 2019-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Congenital Hemiparesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Typically Developing Children

Children with typical development (e.g. no presence of neurological disorders or diagnoses)

No interventions assigned to this group

Children with Hemiparesis

Children diagnosed with Hemiparesis

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernadette T Gillick, PhD, MSPT

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28530154 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29130382 (View on PubMed)

Other Identifiers

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1311M45303

Identifier Type: -

Identifier Source: org_study_id

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