Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-11-30

Brief Summary

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The study investigates safety, feasibility and effectiveness of cervical spinal cord stimulation (SCS) in prevention of cerebral arterial vasospasm following aneurysmal subarachnoid hemorrhage (aSAH).

It is postulated that 2 week long stimulation of the cervical spinal cord using an implanted epidural electrode will prevent or decrease severity of cerebral arterial vasospasm following aSAH.

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Detailed Description

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Continuous stimulation of the cervical spinal cord for 14 days after electrode implantation (within 3 days after aneurysmal subarachnoid hemorrhage). The single-arm single-institution non-randomized prospective study evaluates effects of cervical spinal cord stimulation on prevention of cerebral arterial vasospasm.

The patients are followed for 12 months after completion of stimulation.

Conditions

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Aneurysmal Subarachnoid Hemorrhage

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Active

Spinal cord stimulation

Group Type EXPERIMENTAL

spinal cord stimulation

Intervention Type DEVICE

electrode is inserted into cervical epidural space for continuous spinal cord stimulation

Interventions

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spinal cord stimulation

electrode is inserted into cervical epidural space for continuous spinal cord stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 18-65
* Subarachnoid hemorrhage (SAH) within 72 hours
* Ruptured aneurysm confirmed by angiography of CT angiography
* Fisher grade 2-4
* Hunt \& Hess grade 2-4
* Aneurysm is secured
* Ability to obtain informed consent

Exclusion Criteria

* Pregnancy
* Allergy to IV contrast or to any component of SCS system
* Non-aneurysmal SAH
* Previous cervical spine surgery or any anomaly of cervical spine that would prevent electrode insertion
* Coagulopathy

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No