Longitudinal Outcomes in Pediatric rTMS and CIT

Congenital Hemiparesis Clinical Trial

— Longitudinal  

Official title:

Longitudinal Outcomes in Pediatric rTMS and CIT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091687
• Other study ID #: 1401S47261
• Status: Completed
• Start date: April 2014
• Est. completion date: February 1, 2017

Study information

• Verified date: May 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Track behavioral and qualitative longitudinal outcomes in children with hemiparesis who previously participated in a randomized, controlled trial (RCT) of intensive therapy combined with repetitive Transcranial Magnetic Stimulation (rTMS)

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'.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: February 1, 2017
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Previous participants in a RCT on rTMS/CIT.

Exclusion Criteria:

• Participants who do not wish to participate.

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

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TMS Symptom Checklist	This checklist assists in monitoring children who have had TMS for side effects.	Adminstered at testing session, 2-4 years after intervention.
Secondary	Assisting Hand Assessment	This assessment evaluates how well a child can use his/her hands during every day two handed activities.	at testing session, 2-4 years after intervention.