Cervical Spinal Cord Stimulation for the Prevention of Ce... | NCT00766844

Studies
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm

NCT00766844

Sponsor

Konstantin V. Slavin

Status

Completed

Last Update Posted

Jan 23, 2013Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Aneurysmal Subarachnoid Hemorrhage

Interventions

spinal cord stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
FDA IDE G060177/S001	Other Identifier	FDA

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2009Actual

First Submitted Date

Oct 3, 2008

First Submission Date that Met QC Criteria

Oct 3, 2008

First Posted Date

Oct 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2013

Last Update Posted Date

Jan 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active	Experimental	Spinal cord stimulation	Device: spinal cord stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
spinal cord stimulation	Device	electrode is inserted into cervical epidural space for continuous spinal cord stimulation	Active

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevention of cerebral vasospasm		14-17 days after aSAH

Secondary Outcomes

Measure	Description	Time Frame
Any complication of spinal cord stimulation		up to 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Konstantin V Slavin, MD	University of Illinois at Chicago	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Illinois Medical Center in Chicago		Chicago	Illinois	60612	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35920945	Derived	Slavin KV, Vannemreddy P. Cervical spinal cord stimulation for prevention and treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage: clinical and radiographic outcomes of a prospective single-center clinical pilot study. Acta Neurochir (Wien). 2022 Nov;164(11):2927-2937. doi: 10.1007/s00701-022-05325-4. Epub 2022 Aug 3.

ID	Term
D020300	Intracranial Hemorrhages
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation

ID	Term
D013345	Subarachnoid Hemorrhage
D000783	Aneurysm