The effect of cervical transcutaneous electrical neurostimulation on cerebral blood flow velocities, cerebral vasospasm and ischemic deficit in secondary cerebral vasospasm after subarachnoid haemorrhage

Phase 2

Completed

• Conditions: cerebral vasospasm; spasm of the vessels in the brain; 10007963

• Registration Number: NL-OMON34128
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Confirmed aneurysmatic subarachnoid hemorrhage.
Cerebral vasospasm demonstrated by TCD, defined as a MCA/ICA ratio >3
Aneurysm is treated with a surgical or endovascular procedure.
Age > 18 years.
Treatment can be started promptly.
Informed consent signed by patient or family.

Exclusion Criteria

History of cervical spine or skull-base surgery.
Known adverse reaction to TENS-pads.
The presence of any implanted electronic device (including pacemakers).
Pre-existing disease that can obscure follow-up.
Unacceptable interference with cardiographic registration (in case intensive care is necessary).
Insuficient temporal bony windows

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cerebral bloodflowvelocities as measured by transcranial doppler sonography</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cerebral ischemia as seen on computed tomography scans<br /><br>Cerebral oxygenationas measured by near-infrared spectroscopy<br /><br>Bloodpressure and pulse.<br /><br>Clinical outcome.</p><br>