Aneurysmal Subarachnoid HemorrhagePhase 1NCT00766844
Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm
A Phase 1 study testing spinal cord stimulation in people with Aneurysmal Subarachnoid Hemorrhage, run by Konstantin V. Slavin at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Medical Center in Chicago
Chicago, Illinois, 60612
About this study
Official title: Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510
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.
Read the 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.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- spinal cord stimulation
- Keywords
- vasospasm, spinal cord stimulation, aneurysm, subarachnoid hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal cord stimulationDevice
electrode is inserted into cervical epidural space for continuous spinal cord stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Spinal cord stimulation Receives: Device: spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of cerebral vasospasm
Measured: 14-17 days after aSAH
Secondary outcomes (1)
Any complication of spinal cord stimulation
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konstantin V. Slavin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Konstantin V. Slavin, University of Illinois Chicago
- Investigators
- Konstantin V Slavin, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00766844
- Sponsor's protocol ID
- UIC 2007-0899
- Other IDs
- FDA IDE G060177/S001
- Status last verified
- Jan 2013
- First submitted
- 3 Oct 2008
- Last updated
- 23 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 35920945
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Spinal Cord Stimulation for the Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Using MTS Trial System 3510
- ClinicalTrials.gov ID
- NCT00766844
- Acronym / sponsor ID
- UIC 2007-0899
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- vasospasm, spinal cord stimulation, aneurysm, subarachnoid hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Konstantin V. SlavinUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 6 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: spinal cord stimulationSpinal cord stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal cord stimulationelectrode is inserted into cervical epidural space for continuous spinal cord stimulation | Device | Active |
Primary outcome
Prevention of cerebral vasospasm
Time frame: 14-17 days after aSAH
1 secondary outcome
Any complication of spinal cord stimulation
Time frame: up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2013.
- Derived from this study: PubMed 35920945Slavin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantin V Slavin, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing spinal cord stimulation in people with Aneurysmal Subarachnoid Hemorrhage, run by Konstantin V. Slavin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of cerebral vasospasm (time frame: 14-17 days after aSAH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00766844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2013.