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PubMed
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Stroke Interventions in Clinical Trials
Printable Version
Acceleration of MCA-recanalization by transcranial ultrasound



Principal Investigator
J. Eggers

Contact Address
Günter Seidel, MD
ass. Professor of Neurology
University Hospital Schleswig-Holstein, Campus Lübeck
Ratzeburger Allee 160
D-23538 Lübeck
Germany



Trial Phase:Phase I
Study Size Actual:15
Centers Actual:1
Max Time from onset:6 Hours
Follow-up Duration:90 Days
Status:
Trial complete. Results presented May 2003.

Purpose:
To examine the therapeutic effect of transcranial pulse-wave ultrasound in recanalization and the clinical outcome of patients suffering from acute occlusion of the middle cerebral artery not suitable for thrombolysis.

Location(s):
Germany

Year Presented: 2003
Year Published: 2005


Design:
Randomized clinical trial.

Inclusion Criteria
Patients with acute occlusion of the middle cerebral artery admitted within 6 hours of onset and not suitable for thrombolytic therapy.

Patient Involvement:
Patients were randomized to either receive continuous ultrasound monitoring (n=8) or be in the control group (n=5).

Primary Outcome:
Recanalization and clinical outcome as measure by the NIHSS, modified Ranken Score, and Barthel Index.

Results:
The authors studied the effect of transcranial ultrasound on patients with acute middle cerebral artery occlusion and contraindications for thrombolysis. Fifteen consecutive subjects were randomized for insonation over 1 hour or for inclusion in a control group. By day 4, recanalization and neurologic improvement occurred more frequently in the target group. Ultrasound-induced acceleration of clot dissolution may be an option for patients with contraindications for recombinant tissue plasminogen activator.

Comments:
Results from presentation of abstract at 12th European Stroke Conference (May 2003.):
2 patients in the continous ultrasound monitoring group (study group) showed a partial middle cerebral artery recanalization, 1 showed a complete recanalization. None in the control group recanalized. After 4 days, the study group had a significantly better NIHSS score (median 6.5 vs 21, p=0.006). After 90 days the study group had a better outcome measured by the modified Ranken Score (median 3 vs 5, p=.0.045), and a better outcome measured by the Barthel Index (median 80 vs 50, p=0.024).

Source of Information:
Presented at 12th European Stroke Conference (May 2003).

Web Links and Publications:
Sonothrombolysis in acute ischemic stroke for patients ineligible for rt-PA.
Neurology 2005 Mar 22;64(6):1052-4

This information last updated on: 7/22/2008

Reviewed on: 07/22/2008.

UID: 527

   

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