Ischemic StrokeNCT01005394
Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery
An observational study of Ischemic Stroke, run by Nexstim Ltd at 1 site in United States.
Trial summary
The past 10 years of research in persons more than 6 months post stroke have shown certain types of rehabilitation can help "re-wire" the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this re-wiring by mapping the brain's function (measuring brain activity). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Navigated TMS examination
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Mar 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 20-80 years who have suffered a unilateral ischemic stroke and who will undergo motor rehabilitation at the study center will be asked to participate in the study.
Who may be able to join
- one sided ischemic stroke confirmed by radiology
- 20-80 years old
Who cannot join
- hemorrhagic stroke
- brainstem stroke
- cerebellar stroke
- thalamic stroke
- seizure with the recent stroke
- any history of uncontrolled seizure
Show all 11Show fewer
- history of epilepsy
- pregnancy or planning on getting pregnant during the next year
- MRI incompatibility (e.g. metal implants in body)
- recent history (past year) of alcohol and drug abuse (due to lack of follow up)
- Other criteria include TMS exclusions: aneurysm clips, previous surgery over motor cortex, open craniotomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke
The past 10 years of research in persons more than 6 months post stroke have shown certain types of rehabilitation can help "re-wire" the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this re-wiring by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in brain activity during the first 6 months after stroke (to determine how the brain "re-wires"); 2) compare changes in recovery of motor function with changes in brain re-wiring; 3) determine the ability of TMS to "predict" functional outcome in the first 6 months after stroke.
The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure motor threshold (MT), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes at 3 and 6 months.
- Conditions
- Ischemic Stroke
- Being tested
- Navigated TMS examination
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigated TMS examinationDevice
Also called device: eXimia NBS system
diagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke
| Study group | Role | What they receive |
|---|---|---|
| Navigated TMS | single arm study where all subjects will be studied using the Navigated TMS device Receives: Device: Navigated TMS examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
navigated transcranial magnetic stimulation examination and correlation with motor functional testing
Measured: Enrollment, week 2, week 4 , week 12 and week 24 post-stroke
Secondary outcomes (1)
Safety of navigated transcranial magnetic stimulation examination
Measured: each examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nexstim Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kari Dunning, PhD,PT, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005394
- Sponsor's protocol ID
- DR-NE-002
- Status last verified
- Apr 2015
- First submitted
- 30 Oct 2009
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke
- ClinicalTrials.gov ID
- NCT01005394
- Acronym / sponsor ID
- DR-NE-002
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nexstim LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Nov 2009 (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.
The past 10 years of research in persons more than 6 months post stroke have shown certain types of rehabilitation can help "re-wire" the brain. Transcranial magnetic stimulation (TMS) can be used to monitor this re-wiring by mapping the brain's function (measuring brain activity). Recent research suggests that TMS can be used for both prognosis (determining future function) and to determine what type of rehabilitation therapy will work best after stroke. The purposes of this research study are to: 1) determine changes in brain activity during the first 6 months after stroke (to determine how the brain "re-wires"); 2) compare changes in recovery of motor function with changes in brain re-wiring; 3) determine the ability of TMS to "predict" functional outcome in the first 6 months after stroke.
The primary hypotheses are: 1) functional recovery will be correlated with TMS changes (as measure motor threshold (MT), motor evoked potentials (MEPs) and recruitment curves; 2) baseline TMS will predict future functional outcomes at 3 and 6 months.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Navigated TMS | – | Device: Navigated TMS examinationsingle arm study where all subjects will be studied using the Navigated TMS device |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 20-80 years who have suffered a unilateral ischemic stroke and who will undergo motor rehabilitation at the study center will be asked to participate in the study.
Key inclusion criteria (2 listed)
- one sided ischemic stroke confirmed by radiology
- 20-80 years old
Key exclusion criteria (11 listed)
- hemorrhagic stroke
- brainstem stroke
- cerebellar stroke
- thalamic stroke
- seizure with the recent stroke
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 |
|---|---|---|
| Navigated TMS examinationAlso: device: eXimia NBS systemdiagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke | Device | Navigated TMS |
Primary outcome
navigated transcranial magnetic stimulation examination and correlation with motor functional testing
Time frame: Enrollment, week 2, week 4 , week 12 and week 24 post-stroke
1 secondary outcome
Safety of navigated transcranial magnetic stimulation examination
Time frame: each examination
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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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.
Kari Dunning, PhD,PT principal investigator
University of Cincinnati
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 Ischemic Stroke, run by Nexstim Ltd 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 2 inclusion and 11 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 16 Apr 2015. 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 was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
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?
navigated transcranial magnetic stimulation examination and correlation with motor functional testing (time frame: Enrollment, week 2, week 4 , week 12 and week 24 post-stroke). 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 16 Apr 2015.