Longitudinal Outcomes in Pediatric rTMS and CIT

Completed

• Conditions: Congenital Hemiparesis

• Registration Number: NCT02091687
• Lead Sponsor: University of Minnesota

Brief 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)

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'.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-19
• Study Start: 2014-04
• Primary Completion: 2015-05
• Study Completion: 2017-02-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

• Previous participants in a RCT on rTMS/CIT.

Read More

Exclusion Criteria

• Participants who do not wish to participate.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TMS Symptom Checklist	Adminstered at testing session, 2-4 years after intervention.	This checklist assists in monitoring children who have had TMS for side effects.

Secondary Outcome Measures

Name	Time	Method
Assisting Hand Assessment	at testing session, 2-4 years after intervention.	This assessment evaluates how well a child can use his/her hands during every day two handed activities.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States