HemiparesisPhase 1TMSCSNCT01637129
Transcranial Magnetic Stimulation in Children With Stroke
A Phase 1 study testing Transcranial Magnetic Stimulation in people with Hemiparesis and Neonatal Stroke, run by Nationwide Children's Hospital at 2 sites in United States.
Trial summary
This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal stroke. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Hemiparesis, Neonatal Stroke, Ischemic Stroke
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2012to Aug 2013
- Phase
- Phase 1
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A history of ischemic or hemorrhagic stroke at least 6 months prior to recruitment, and causing current unilateral motor impairment of hand function (scoring 1-3 on a modified Ashworth scale; scale explained in Appendix).
- Cerebral infarction spares the transcallosal pathways.
- Cerebral injury confirmed by brain MRI or CT
- Ages 6-18 years inclusive.
Who cannot join
- The presence of an implanted device such as a pacemaker, vagal nerve stimulator, or recently implanted cardiovascular stent; arterial aneurysms; arteriovenous malformations; obstructive hydrocephalus.
- Infarction of the cortical motor areas.
- Presence of a brain tumor or suspected neurodegenerative disease.
- Intractable epilepsy or a history of poorly controlled epilepsy.
- Current use of medications that may lower seizure threshold (such as specific antipsychotics, specific antidepressants, amphetamines)
- Hand function limited to rigid flexion or extension (score = 4 on the modified Ashworth scale)
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- Disorders causing hallucinations, delusions, or excessive anxiety or depression.
- Pre-existing chronic pain syndromes including intractable headache and chronic daily headache.
- Pregnancy.
- Any sensorimotor or cognitive impairment that prevents valid responses on study measures.
- Bilateral strokes (cerebral injuries) involving motor cortex and/or corpus callosum
- All patients and parents must be naïve regarding the effects and sensations of rTMS (i.e., patients and/or parents with prior exposure to TMS will be excluded).
- Subject has had a recent neurosurgical procedure involving the brain.
- Subject suffered traumatic brain injury that places the subject at risk of seizures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nationwide Children's Hospital
Columbus, Ohio, 43205
The Ohio State University School of Health and Rehabilitation Sciences
Columbus, Ohio, 43210
About this study
This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal stroke.
Read the detailed description
The investigators will begin to test the hypothesis that rTMS will be tolerated and will result in improved hand strength and mobility when compared with sham stimulation.
Aim 1: To determine whether 1 Hz rTMS applied to the hemisphere opposite the infarct (contralesional or healthy hemisphere) is tolerated by children ages 6-18 years who have chronic motor sequelae from a stroke.
Aim 2: To determine whether 8 sessions of inhibitory 1 Hz rTMS to the contralesional healthy hemisphere improves grip strength and hand mobility when compared with sham stimulation in controls.
- Being tested
- Transcranial Magnetic Stimulation, Sham Magnetic Stimulation
- Keywords
- Childhood stroke, Perinatal stroke, Pediatric stroke, Presumed perinatal stroke, Children who have hemiparesis
- Medical subject headings
- Paresis, Ischemic Stroke, Hemorrhagic Stroke, Thrombotic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Also called MagStim
Transcranial Magnetic Stimulation, repetitive at 1Hz
Sham Magnetic StimulationDevice
Also called MagStim
Sham Magnetic Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Stimulation | Active comparator | Active Magnetic Stimulation with repetitive transcranial magnetic stimulation Receives: Device: Transcranial Magnetic Stimulation |
| No Intervention | Placebo comparator | Sham Magnetic Stimulation Receives: Device: Sham Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance to repetitive stimulation
The patient's reports of side effects recorded on the CRF at each session will be tabulated and the pre-stimulation scores will be subtracted from the post-stimulation scores.
Cognitive function will be assessed with 6 measures (Executive Function / Spatial Problem Solving, Psychomotor Function / Speed of Processing, Visual Attention / Vigilance, Visual Learning \& Memory, Verbal Learning \& Memory, and Attention / Working Memory measures). As with the tolerance assessments, we will tabulate before-stimulation and after-stimulation assessments and analyze the difference.
Measured: Up to 2 days
Secondary outcomes (1)
Upper extremity strength and mobility
Upper extremity strength will be assessed with a Jtech dynamometer at three different locations: elbow extension (triceps), elbow flexion (biceps), and grip.
Joint mobility at the elbow and wrist will be assessed with the modified Ashworth score.
Measured: Up to 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Principal investigator, Warren Lo, Nationwide Children's Hospital
- Investigators
- Warren Lo, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637129
- Sponsor's protocol ID
- IRB11-00324
- Other IDs
- 273611
- Acronym
- TMSCS
- Status last verified
- Mar 2014
- First submitted
- 25 Jun 2012
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation in Children With Stroke
- ClinicalTrials.gov ID
- NCT01637129
- Acronym / sponsor ID
- TMSCS / IRB11-00324
- Keywords
- Childhood stroke, Perinatal stroke, Pediatric stroke, Presumed perinatal stroke, Children who have hemiparesis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- May 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Jul 2012 (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.
This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal stroke.
Detailed description
The investigators will begin to test the hypothesis that rTMS will be tolerated and will result in improved hand strength and mobility when compared with sham stimulation.
Aim 1: To determine whether 1 Hz rTMS applied to the hemisphere opposite the infarct (contralesional or healthy hemisphere) is tolerated by children ages 6-18 years who have chronic motor sequelae from a stroke.
Aim 2: To determine whether 8 sessions of inhibitory 1 Hz rTMS to the contralesional healthy hemisphere improves grip strength and hand mobility when compared with sham stimulation in controls.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Stimulation | Active comparator | Device: Transcranial Magnetic StimulationActive Magnetic Stimulation with repetitive transcranial magnetic stimulation |
| No Intervention | Placebo comparator | Device: Sham Magnetic StimulationSham Magnetic Stimulation |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- A history of ischemic or hemorrhagic stroke at least 6 months prior to recruitment, and causing current unilateral motor impairment of hand function (scoring 1-3 on a modified Ashworth scale; scale explained in Appendix).
- Cerebral infarction spares the transcallosal pathways.
- Cerebral injury confirmed by brain MRI or CT
- Ages 6-18 years inclusive.
Key exclusion criteria (14 listed)
- The presence of an implanted device such as a pacemaker, vagal nerve stimulator, or recently implanted cardiovascular stent; arterial aneurysms; arteriovenous malformations; obstructive hydrocephalus.
- Infarction of the cortical motor areas.
- Presence of a brain tumor or suspected neurodegenerative disease.
- Intractable epilepsy or a history of poorly controlled epilepsy.
- Current use of medications that may lower seizure threshold (such as specific antipsychotics, specific antidepressants, amphetamines)
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 |
|---|---|---|
| Transcranial Magnetic StimulationAlso: MagStimTranscranial Magnetic Stimulation, repetitive at 1Hz | Device | Magnetic Stimulation |
| Sham Magnetic StimulationAlso: MagStimSham Magnetic Stimulation | Device | No Intervention |
Primary outcome
Tolerance to repetitive stimulation
Time frame: Up to 2 days
The patient's reports of side effects recorded on the CRF at each session will be tabulated and the pre-stimulation scores will be subtracted from the post-stimulation scores. Cognitive function will be assessed with 6 measures (Executive Function / Spatial Problem Solving, Psychomotor Function / Speed of Processing, Visual Attention / Vigilance, Visual Learning \& Memory, Verbal Learning \& Memory, and Attention / Working Memory measures). As with the tolerance assessments, we will tabulate before-stimulation and after-stimulation assessments and analyze the difference.
1 secondary outcome
Upper extremity strength and mobility
Time frame: Up to 2 Months
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 1 Apr 2014.
Related trials for Hemiparesis
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Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls
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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.
Warren Lo, MD principal investigator
Nationwide Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transcranial Magnetic Stimulation in people with Hemiparesis and Neonatal Stroke, run by Nationwide Children's Hospital at 2 sites 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 4 inclusion and 14 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 1 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Tolerance to repetitive stimulation (time frame: Up to 2 days). 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 1 Apr 2014.