Cervical Spinal Cord Stimulation in Cerebral Vasospasm (SCSinCV)

March 20, 2018 updated by: Scott C. Palmer, M.D., Mayo Clinic

A Safety and Feasibility Study of the Use of Cervical Spinal Cord Stimulation for Treatment of Cerebral Vasospasm in Patients With Aneurysmal Subarachnoid Hemorrhage

The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

The study is a non-blinded evaluation of the use of cervical spinal cord stimulation (SCS) for treatment of patients with Hunt and Hess grade 1-2 subarachnoid hemorrhage and evidence of cerebral vasospasm. Stimulation will be provided with electrodes placed percutaneously in the upper cervical epidural space. The outcome of 5 patients will be studied with focus on possible adverse events related to the intervention. Vasospasm response to treatment will be measured as a secondary outcome. Middle cerebral artery flow velocity will be followed by transcranial Doppler and clinical outcome measured by NIH stroke scale. Flow velocities will be monitored daily by transcranial Doppler and NIH stroke scale performed daily for 7 days, after which spinal cord stimulation will be discontinued and the epidural lead removed.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • a history of aneurysmal subarachnoid hemorrhage and will have aneurysm secured by clipping or coiling.
  • evidence of vasospasm on TCD with MCA mean flow velocity >120 cm/s.
  • Patients must be clinically stable to leave the ICU for the study intervention.
  • Patients will have Hunt and Hess grade 1-2 non-traumatic subarachnoid hemorrhage.
  • Patient should be oriented patients able to provide informed consent.

Exclusion Criteria:

  • Patients with non-aneurysmal hemorrhage
  • Patient with coagulopathy (PTT>40, or INR > 1.2)
  • thrombocytopenia (platelets <100 x 103 per mm2).
  • Use of anticoagulation or antiplatelet medication within the known clinical effective period of the particular medication.
  • allergy to nimodipine.
  • History of cervical or thoracic spine surgery.
  • Skin infection at site of catheter placement.
  • Sepsis. Pregnancy. Age less than 18 or greater than 80. Active diagnosis of cancer or history of metastatic cancer. Presence of cardiac defibrillator. Inability or unwillingness of patient to give informed consent. Patients found to be clinically neurologically unstable, hemodynamically unstable, or suffering from unstable intracranial pressure at the time of assessment for lead placement will not have the intervention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCS in CV
Device: Spinal Cord Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Looking at number of patients without an adverse effect
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Scott C Palmer, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

April 22, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (Estimate)

April 27, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2018

Last Update Submitted That Met QC Criteria

March 20, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-007493

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cerebral Vasospasm

Clinical Trials on Spinal Cord Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe