Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

Terminated

Phase N/A Results N/A

Trial Description

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.

Trial Stopped: Insufficient recruitment

Conditions

Interventions

  • Navigated TMS examination Device
    Other Names: device: eXimia NBS system
    Intervention Desc: diagnostic examination using a single pulse TMS paradigm to evaluate corticospinal motor tract integrity and its evolution after stroke
    ARM 1: Kind: Experimental
    Label: Navigated TMS
    Description: single arm study where all subjects will be studied using the Navigated TMS device

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial 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.

Outcomes

Type Measure Time Frame Safety Issue
Primary navigated transcranial magnetic stimulation examination and correlation with motor functional testing Enrollment, week 2, week 4 , week 12 and week 24 post-stroke No
Secondary Safety of navigated transcranial magnetic stimulation examination each examination Yes

Sponsors