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Completed

NCT Number: NCT02091687

Longitudinal Outcomes in Pediatric rTMS and CIT

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)

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Key information

Conditions

Congenital Hemiparesis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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'.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous participants in a RCT on rTMS/CIT.

Exclusion criteria

  • Participants who do not wish to participate.

Treatment and study plan

Primary outcomes

  1. TMS Symptom Checklist

    Time frame: Adminstered at testing session, 2-4 years after intervention.

    This checklist assists in monitoring children who have had TMS for side effects.

Secondary outcomes

  1. Assisting Hand Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Acronym: Longitudinal

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Mar 19, 2014
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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