Longitudinal Outcomes in Pediatric rTMS and CIT

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02091687

Acronym

Longitudinal

Enrollment

Registered

2014-03-19

Start date

2014-04-30

Completion date

2017-02-01

Last updated

2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Hemiparesis

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'.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Previous participants in a RCT on rTMS/CIT.

Exclusion criteria

* Participants who do not wish to participate.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results