Congenital Hemiparesis Clinical Trial
Official title:
Comparing the Location of the Motor Cortex in Children Using Two Methods: EEG and TMS
NCT number | NCT02015338 |
Other study ID # | 1311M45303 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 2014 |
Est. completion date | December 2015 |
Verified date | July 2019 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02091687 -
Longitudinal Outcomes in Pediatric rTMS and CIT
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