Navigated Transcranial Magnetic Stimulation in Monitoring Stroke Recovery

Ischemic Stroke Clinical Trial

Official title:

Acute Longitudinal Transcranial Magnetic Stimulation (TMS) After Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01005394
• Other study ID #: DR-NE-002
• Status: Terminated
• Phase: N/A
• First received: October 30, 2009
• Last updated: April 15, 2015
• Start date: October 2009
• Est. completion date: March 2014

Study information

• Verified date: April 2015
• Source: Nexstim Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	Drake Rehabilitation Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nexstim Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	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