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Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01005394
Enrollment
5
Registered
2009-11-02
Start date
2009-10-31
Completion date
2014-03-31
Last updated
2015-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Brief 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). 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.

Interventions

DEVICENavigated TMS examination

diagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke

Sponsors

Nexstim Ltd
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* one sided ischemic stroke confirmed by radiology * 20-80 years old

Exclusion criteria

* hemorrhagic stroke * brainstem stroke * cerebellar stroke * thalamic stroke * seizure with the recent stroke * any history of uncontrolled seizure * 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

Design outcomes

Primary

MeasureTime frame
navigated transcranial magnetic stimulation examination and correlation with motor functional testingEnrollment, week 2, week 4 , week 12 and week 24 post-stroke

Secondary

MeasureTime frame
Safety of navigated transcranial magnetic stimulation examinationeach examination

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026