Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

NCT01005394 | Terminated DMC

• 1 other identifier: DR-NE-002
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• navigated transcranial magnetic stimulation examination and correlation with motor functional testing

  Enrollment, week 2, week 4 , week 12 and week 24 post-stroke

Secondary Outcomes (1)

• Safety of navigated transcranial magnetic stimulation examination

  each examination

Study Arms (1)

Navigated TMS

single arm study where all subjects will be studied using the Navigated TMS device

Device: Navigated TMS examination

Interventions

Navigated TMS examination DEVICE

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

Also known as: device: eXimia NBS system

Navigated TMS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• one sided ischemic stroke confirmed by radiology
• years old

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nexstim Ltd: lead

Study Sites (1)

Drake Rehabilitation Center

Cincinnati, Ohio, 45216, United States

Location

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kari Dunning, PhD,PT

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

US (1)