- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02091687
Longitudinal Outcomes in Pediatric rTMS and CIT (Longitudinal)
Study Overview
Status
Conditions
Detailed Description
This longitudinal study will evaluate the subjective and behavioral outcomes of a previous randomized controlled study (RCT) rTMS/CIT (Pediatric Hemiparesis: Synergistic Treatment using rTMS and CIT (NIH Grant Number: 1RC1HD063838-01; PI: Dr. James Carey). The previous rTMS/CIT study evaluated the safety and efficacy of 5 treatments of 6-Hz primed low-frequency rTMS applied to the non-stroke hemisphere combined with constraint induced therapy (CIT) to promote recovery of the paretic hand in children and adolescents. CIT has shown improved behavioral outcomes as well as cortical reorganization in representation of the affected limb. The previous RCT was a rTMS-Sham/CIT study design (real rTMS n=10 and sham rTMS n=9).
Our research question, 'What is the medical status and perception of previous participants concerning their involvement in an intensive rTMS/CIT RCT specific to symptom monitoring, the TMS experience, and their current functional status'.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Previous participants in a RCT on rTMS/CIT.
Exclusion Criteria:
- Participants who do not wish to participate.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TMS Symptom Checklist
Time Frame: Adminstered at testing session, 2-4 years after intervention.
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This checklist assists in monitoring children who have had TMS for side effects.
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Adminstered at testing session, 2-4 years after intervention.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assisting Hand Assessment
Time Frame: at testing session, 2-4 years after intervention.
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This assessment evaluates how well a child can use his/her hands during every day two handed activities.
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at testing session, 2-4 years after intervention.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bernadette T Gillick, PhD, MSPT, PT, University of Minnesota
Publications and helpful links
General Publications
- Rich TL, Menk J, Krach LE, Feyma T, Gillick BT. Repetitive Transcranial Magnetic Stimulation/Behavioral Intervention Clinical Trial: Long-Term Follow-Up of Outcomes in Congenital Hemiparesis. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):598-605. doi: 10.1089/cap.2015.0157. Epub 2016 Feb 23.
- Rich T, Cassidy J, Menk J, Van Heest A, Krach L, Carey J, Gillick BT. Stability of stereognosis after pediatric repetitive transcranial magnetic stimulation and constraint-induced movement therapy clinical trial. Dev Neurorehabil. 2017 Apr;20(3):169-172. doi: 10.3109/17518423.2016.1139008. Epub 2016 Mar 17.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1401S47261
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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