Pediatric StrokeNCT02057276
Repetitive TMS and Occupational Therapy in Children and Young Adults With Chronic Hemiparesis
A study testing Repetitive Transcranial Magnetic Stimulation and Occupational Therapy in people with Pediatric Stroke and Cerebral Palsy, run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Repetitive Transcranial Magnetic Stimulation (rTMS) can augment occupational therapy in improving motor function in children (10 years of age or older) and young adults (< 21 years of age) with chronic hemiparesis from either stroke or cerebral palsy. Read more about this study
- Who is it for?
- Ages 10 to 20 years
- Conditions the study is for
- Pediatric Stroke, Cerebral Palsy, Chronic Hemiparesis
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation and Occupational Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥ 10 years; < 21 years
- Hemiparesis
- Manual Ability Classification System (MACS) level I through IV
- Provision of written informed consent by the patient and/or guardian, including understanding that insurance may be billed for the occupational therapy
- Written assent form signed by participants younger than 18 years of age
Who cannot join
- Underlying degenerative or metabolic disorder or supervening medical illness
- Severe depression or other psychiatric disorder
- Any participant who is pregnant
- Any contraindication to TMS (i.e., intracranial metal implants, shunts, ports, pacemaker, baclofen pumps)
- Any changes or addition of neuropsychiatric medications within 1 month of starting the study or during course of the study (if applicable)
- Any botulinum toxin (Botox, Myobloc) or phenol injection within the last 3 months prior to the study or during the course of the study (if applicable)
- Any upper extremity surgery within the last 6 months prior to the study or scheduled during the course of the study (if applicable)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
About this study
Official title: Motor Control Enhancement Through Repetitive Transcranial Magnetic Stimulation Plus Rehabilitation in Hemiparetic Cerebral Palsy and Stroke
The purpose of this study is to determine whether Repetitive Transcranial Magnetic Stimulation (rTMS) can augment occupational therapy in improving motor function in children (10 years of age or older) and young adults (< 21 years of age) with chronic hemiparesis from either stroke or cerebral palsy.
Read the detailed description
RTMS is a noninvasive technology that can induce changes in brain function that may lead to functional improvement in people with hemiparesis. This is a randomized, double-blinded, sham-controlled rTMS study in conjunction with intensive daily occupational therapy (OT) for 2 weeks to improve motor function in hemiparetic patients. Participants will be followed for at least 12 weeks after rTMS to detect any clinical change. The sham group participants will be offered an open-label active rTMS treatment plus OT after the 12 week assessment.
- Conditions
- Pediatric Stroke, Cerebral Palsy, Chronic Hemiparesis
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation, Occupational Therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
Sham Repetitive Transcranial Magnetic StimulationDevice
Occupational TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Active comparator | Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Receives: Device: Repetitive Transcranial Magnetic Stimulation; Other: Occupational Therapy |
| Sham rTMS | Sham comparator | Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation; Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
Measured: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2014 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionJun 2016
Why it stopped: Study was terminated due to low recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric StrokeStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steve W Wu, MD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057276
- Sponsor's protocol ID
- CIN001 - rTMS/hemiparesis
- Other IDs
- 2012-1533
- Status last verified
- Feb 2017
- First submitted
- 5 Jun 2013
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor Control Enhancement Through Repetitive Transcranial Magnetic Stimulation Plus Rehabilitation in Hemiparetic Cerebral Palsy and Stroke
- ClinicalTrials.gov ID
- NCT02057276
- Acronym / sponsor ID
- CIN001 - rTMS/hemiparesis
- Conditions
- Pediatric Stroke, Cerebral Palsy, Chronic Hemiparesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to low recruitment.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 7 Feb 2014 (estimated)
- Results
- Posted 3 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Repetitive Transcranial Magnetic Stimulation (rTMS) can augment occupational therapy in improving motor function in children (10 years of age or older) and young adults (< 21 years of age) with chronic hemiparesis from either stroke or cerebral palsy.
Detailed description
RTMS is a noninvasive technology that can induce changes in brain function that may lead to functional improvement in people with hemiparesis. This is a randomized, double-blinded, sham-controlled rTMS study in conjunction with intensive daily occupational therapy (OT) for 2 weeks to improve motor function in hemiparetic patients. Participants will be followed for at least 12 weeks after rTMS to detect any clinical change. The sham group participants will be offered an open-label active rTMS treatment plus OT after the 12 week assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Active comparator | Device: Repetitive Transcranial Magnetic Stimulation, Other: Occupational TherapyParticipants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. |
| Sham rTMS | Sham comparator | Device: Sham Repetitive Transcranial Magnetic Stimulation, Other: Occupational TherapyParticipants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. |
Who may qualify
- Ages
- 10 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age ≥ 10 years; < 21 years
- Hemiparesis
- Manual Ability Classification System (MACS) level I through IV
- Provision of written informed consent by the patient and/or guardian, including understanding that insurance may be billed for the occupational therapy
- Written assent form signed by participants younger than 18 years of age
Key exclusion criteria (7 listed)
- Underlying degenerative or metabolic disorder or supervening medical illness
- Severe depression or other psychiatric disorder
- Any participant who is pregnant
- Any contraindication to TMS (i.e., intracranial metal implants, shunts, ports, pacemaker, baclofen pumps)
- Any changes or addition of neuropsychiatric medications within 1 month of starting the study or during course of the study (if applicable)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationWe will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study. | Device | Active rTMS |
| Sham Repetitive Transcranial Magnetic Stimulation | Device | Sham rTMS |
| Occupational Therapy | Other | Active rTMS, Sham rTMS |
Primary outcome
Change in the "Melbourne Assessment of Unilateral Upper Limb Function"
Time frame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Steve W Wu, MD principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation and Occupational Therapy in people with Pediatric Stroke and Cerebral Palsy, run by Children's Hospital Medical Center, Cincinnati 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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 14 Mar 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the "Melbourne Assessment of Unilateral Upper Limb Function" (time frame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2017.