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临床试验/NCT02091687
NCT02091687已完成不适用

Longitudinal Outcomes in Pediatric rTMS and CIT

University of Minnesota1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
试验地点
1
主要终点
TMS Symptom Checklist

研究概览

简要总结

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)

详细描述

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'.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Previous participants in a RCT on rTMS/CIT.

排除标准

  • Participants who do not wish to participate.

结局指标

主要结局

TMS Symptom Checklist

时间窗: Adminstered at testing session, 2-4 years after intervention.

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

次要结局

  • Assisting Hand Assessment(at testing session, 2-4 years after intervention.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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