Clinical trial NCT02091687: Longitudinal Outcomes in Pediatric rTMS and CIT
Official title: Longitudinal Outcomes in Pediatric rTMS and CIT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Hemiparesis
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previous participants in a randomized controlled study (RCT) rTMS/CIT (Pediatric Hemiparesis: Synergistic Treatment using rTMS and CIT (NIH Grant Number: 1RC1HD063838-01; PI: Dr. James Carey)

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'.

Eligibility criteria: Inclusion Criteria:

* Previous participants in a RCT on rTMS/CIT.

Exclusion Criteria:

* Participants who do not wish to participate.

Primary outcomes:
measure: TMS Symptom Checklist
timeFrame: Adminstered at testing session, 2-4 years after intervention.
Secondary outcomes:
measure: Assisting Hand Assessment
timeFrame: at testing session, 2-4 years after intervention.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Bernadette T Gillick, PhD, MSPT, PT
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.