Congenital HemiparesisLongitudinalNCT02091687
Longitudinal Outcomes in Pediatric rTMS and CIT
An observational study of Congenital Hemiparesis, run by University of Minnesota at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congenital Hemiparesis
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 1 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- Previous participants in a RCT on rTMS/CIT.
Who cannot join
- Participants who do not wish to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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)
Read the 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'.
- Conditions
- Congenital Hemiparesis
What is being measured
The primary outcome is the main question the study is designed to answer.
TMS Symptom Checklist
This checklist assists in monitoring children who have had TMS for side effects.
Measured: Adminstered at testing session, 2-4 years after intervention.
Secondary outcomes (1)
Assisting Hand Assessment
This assessment evaluates how well a child can use his/her hands during every day two handed activities.
Measured: at testing session, 2-4 years after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2015
- Study completion1 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital HemiparesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernadette T Gillick, PhD, MSPT, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02091687
- Sponsor's protocol ID
- 1401S47261
- Acronym
- Longitudinal
- Status last verified
- May 2023
- First submitted
- 17 Mar 2014
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26905272Rich 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.
PubMed 26985568
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Outcomes in Pediatric rTMS and CIT
- ClinicalTrials.gov ID
- NCT02091687
- Acronym / sponsor ID
- Longitudinal / 1401S47261
- Conditions
- Congenital Hemiparesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2015 (actual)
- Study completion
- 1 Feb 2017 (actual)
- First posted
- 19 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (1 listed)
- Previous participants in a RCT on rTMS/CIT.
Key exclusion criteria (1 listed)
- Participants who do not wish to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Assisting Hand Assessment
Time frame: at testing session, 2-4 years after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 26905272Rich 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.
- Background: PubMed 26985568Rich 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernadette T Gillick, PhD, MSPT, PT principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Hemiparesis, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TMS Symptom Checklist (time frame: Adminstered at testing session, 2-4 years after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02091687, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.