Cerebral VasospasmNCT05150002
Cervical Spinal Cord Stimulation in Patients With Cerebral Vasospasm After Subarachnoid Haemorrhage: VasoStim Study
A study testing Spinal cord stimulation in people with Cerebral Vasospasm and Subarachnoid Hemorrhage, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Cerebral vasospasm is characterized by a vasoconstriction of cerebral arteries causing a reduction of cerebral blood flow (CBF) and leading to ischemia and infarction of the brain parenchyma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Vasospasm, 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
- 1 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Jun 2023to 6 Jan 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fisher 3 grade subarachnoid hemorrhage at presentation
- Secured aneurysm by clipping or coiling
- Is 18-75 years of age at the time of enrollment
- Cerebral vasospasm:
- Cerebral angiography
- o Narrowing of vessel lumen > 66%
Show all 19Show fewer
- Transcranial Doppler ultrasound
- Mean flow velocity > 150 cm/s or
- Lindegaard Index > 3 or
- increase > 50 cm/s within 24 hours
- Intracranial CT angiography
- o Narrowing of vessel lumen > 66%
- Intracranial CT perfusion o Time To Drain (TTD) > 4.7 seconds
- Is willing and capable of providing informed consent or existence of the presumed will of the patient by a relative or a legal representative
- Written confirmation by a study independent physician to guarantee patient interest
- Is willing and capable of complying with the study related requirements, procedures, and visits
- No findings on spinal imaging preventing SCS lead implantation
- Negative pregnancy test
- No breast feeding
Who cannot join
- Untreated ruptured aneurysm
- Cerebral infarction in the territory of the spastic arteries or massive disseminated infarction
- Signs of cerebral herniation
- Uncontrollable intracranial pressure
- Infection
- Coagulation disorder
Show all 11Show fewer
- Is participating in another interventional trial
- Circulatory instability
- Severe congestive heart failure
- Patients with an elevated risk of bleeding
- Known allergy to implanted materials (Silicon, Titanium)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Neurosurgery, Bern University Hospital
Bern, 3000
About this study
Cerebral vasospasm is characterized by a vasoconstriction of cerebral arteries causing a reduction of cerebral blood flow (CBF) and leading to ischemia and infarction of the brain parenchyma. Cerebral vasospasm is a serious complication of aneurysmal subarachnoid hemorrhage (SAH) with high morbidity and overall mortality of 40-50%.
Although the exact mechanisms of spinal cord stimulation (SCS) on the innervation of cerebral vessels are still unclear, several hypotheses have been formulated and studies in animals and human performed with very promising results.
This is a proof of concept study to better understand the effect and mechanisms of cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH in human.
Read the detailed description
Cerebral vasospasm is characterized by a vasoconstriction of cerebral arteries causing a reduction of cerebral blood flow (CBF) and leading to ischemia and infarction of the brain parenchyma. Cerebral vasospasm is a serious complication of aneurysmal subarachnoid hemorrhage (SAH) with high morbidity and overall mortality of 40-50%. The exact pathophysiological mechanisms underlying cerebral vasospasm are still not known in detail.
A wide range of different therapeutic options with various efficacies are available, triple-H therapy and endovascular treatment options like intra-arterial application of vasodilators e.g. Nimodipine or Papaverine or transluminal balloon angioplasty have been reported and are applied to prevent and treat cerebral vasospasm after SAH. Calcium channel blockers such as nimodipine or nicardipine improve outcome in patients after SAH and reduce the risk of secondary ischemia. The benefit of the different therapies is undoubted, but there is still potential for improvement concerning the rate of morbidity and mortality.
Although the exact mechanisms of spinal cord stimulation (SCS) on the innervation of cerebral vessels are still unclear, several hypotheses have been formulated and studies in animals and human performed with very promising results.
This is a proof of concept study to better understand the effect and mechanisms of cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH in human.
Subjects are enrolled into the study, if radiographical vasospasms are detected in CTA, CTP, cerebral angiography or TCD.
SCS leads are implanted within 12h after study enrolment following the investigator's standard practice. SCS will be continuously delivered until day 14 after SAH. Doppler ultrasound is performed before SCS lead implantation and repeated after implantation on a daily basis and appearance of a new neurological deficit device until 24h after stopping the stimulation. Efficacy of cervical SCS is further evaluated by CTA or angiography and CTA/P performed 48h and 96h after lead implantation, as well as on day 14 after SAH before stopping the stimulation. The SCS electrode(s) are explanted on day 15. Intracerebral pressure is monitored from day 7-15. Headache, measured as NRS 0-10 and the consumption of analgesics are monitored from day 7-15, at discharge, at 3 and 6 months.
- Conditions
- Cerebral Vasospasm, Subarachnoid Hemorrhage
- Being tested
- Spinal cord stimulation
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulationDevice
Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH
| Study group | Role | What they receive |
|---|---|---|
| Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH | Experimental | Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH Receives: Device: Spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of baseline flow velocity
The change of baseline flow velocity from the onset of vasospasm to day 14 assessed with Doppler ultrasound showing the effect of cervical SCS.
Measured: 14 days after onset vasospasm
Secondary outcomes (12)
Vasospasm changes in angiography and perfusion in CTP
Vasospasm changes in angiography and perfusion in CTP
Measured: 48 hours after stimulation
Vasospasm changes in CTA and perfusion in CTP
Vasospasm changes in CTA and perfusion in CTP
Measured: 48 hours after stimulation
Vasospasm changes in angiography and perfusion in CTP
Vasospasm changes in angiography and perfusion in CTP
Measured: 96 hours after stimulation
Vasospasm changes in CTA and perfusion in CTP
Vasospasm changes in CTA and perfusion in CTP
Measured: 96 hours after stimulation
Vasospasm changes in CTA and perfusion in CTP
Vasospasm changes in CTA and perfusion in CTP
Measured: 14 days after stimulation
Vasospasm changes in angiography and perfusion in CTP
Vasospasm changes in angiography and perfusion in CTP
Measured: 14 days after stimulation
Triple-H therapy
Development of symptomatic vasospasm from onset to day 14 with need for Triple-H therapy
Measured: 14 days after stimulation
Angioplasty or intra-arterial application of vasodilators
Development of symptomatic vasospasm from onset to day 14 with need for angioplasty or intra-arterial application of vasodilators
Measured: 14 days after stimulation
Intracerebral pressure (ICP)
Intracerebral pressure (ICP)
Measured: Day 7- 14
Headache
Headache measured by VAS Scale (Score 0-10 with 0 representing no pain, and 10 maximum pain intensity)
Measured: Day 7- 14
Consumption of analgesics
Consumption of analgesics
Measured: Day 7- 14
Side effects of SCS
Side effects of SCS
Measured: Day 7- 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start30 Jun 2023
- Primary completion12 Dec 2025
- Study completion6 Jan 2026
Why it stopped: Sponsor left
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral VasospasmStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janine Ai Schlaeppi, MD, Principal investigator, Department of Neurosurgery, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150002
- Sponsor's protocol ID
- VasoStim
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2021
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Spinal Cord Stimulation in Patients With Cerebral Vasospasm After Subarachnoid Haemorrhage: VasoStim Study
- ClinicalTrials.gov ID
- NCT05150002
- Acronym / sponsor ID
- VasoStim
- Conditions
- Cerebral Vasospasm, Subarachnoid Hemorrhage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor left
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 8 Dec 2021 (actual)
- 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.
Cerebral vasospasm is characterized by a vasoconstriction of cerebral arteries causing a reduction of cerebral blood flow (CBF) and leading to ischemia and infarction of the brain parenchyma. Cerebral vasospasm is a serious complication of aneurysmal subarachnoid hemorrhage (SAH) with high morbidity and overall mortality of 40-50%.
Although the exact mechanisms of spinal cord stimulation (SCS) on the innervation of cerebral vessels are still unclear, several hypotheses have been formulated and studies in animals and human performed with very promising results.
This is a proof of concept study to better understand the effect and mechanisms of cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH in human.
Detailed description
Cerebral vasospasm is characterized by a vasoconstriction of cerebral arteries causing a reduction of cerebral blood flow (CBF) and leading to ischemia and infarction of the brain parenchyma. Cerebral vasospasm is a serious complication of aneurysmal subarachnoid hemorrhage (SAH) with high morbidity and overall mortality of 40-50%. The exact pathophysiological mechanisms underlying cerebral vasospasm are still not known in detail.
A wide range of different therapeutic options with various efficacies are available, triple-H therapy and endovascular treatment options like intra-arterial application of vasodilators e.g. Nimodipine or Papaverine or transluminal balloon angioplasty have been reported and are applied to prevent and treat cerebral vasospasm after SAH. Calcium channel blockers such as nimodipine or nicardipine improve outcome in patients after SAH and reduce the risk of secondary ischemia. The benefit of the different therapies is undoubted, but there is still potential for improvement concerning the rate of morbidity and mortality.
Although the exact mechanisms of spinal cord stimulation (SCS) on the innervation of cerebral vessels are still unclear, several hypotheses have been formulated and studies in animals and human performed with very promising results.
This is a proof of concept study to better understand the effect and mechanisms of cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH in human.
Subjects are enrolled into the study, if radiographical vasospasms are detected in CTA, CTP, cerebral angiography or TCD.
SCS leads are implanted within 12h after study enrolment following the investigator's standard practice. SCS will be continuously delivered until day 14 after SAH. Doppler ultrasound is performed before SCS lead implantation and repeated after implantation on a daily basis and appearance of a new neurological deficit device until 24h after stopping the stimulation. Efficacy of cervical SCS is further evaluated by CTA or angiography and CTA/P performed 48h and 96h after lead implantation, as well as on day 14 after SAH before stopping the stimulation. The SCS electrode(s) are explanted on day 15. Intracerebral pressure is monitored from day 7-15. Headache, measured as NRS 0-10 and the consumption of analgesics are monitored from day 7-15, at discharge, at 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH | Experimental | Device: Spinal cord stimulationCervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Fisher 3 grade subarachnoid hemorrhage at presentation
- Secured aneurysm by clipping or coiling
- Is 18-75 years of age at the time of enrollment
- Cerebral vasospasm:
- o Narrowing of vessel lumen > 66%
Key exclusion criteria (11 listed)
- Untreated ruptured aneurysm
- Cerebral infarction in the territory of the spastic arteries or massive disseminated infarction
- Signs of cerebral herniation
- Uncontrollable intracranial pressure
- Infection
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 stimulationCervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH | Device | Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH |
Primary outcome
Change of baseline flow velocity
Time frame: 14 days after onset vasospasm
The change of baseline flow velocity from the onset of vasospasm to day 14 assessed with Doppler ultrasound showing the effect of cervical SCS.
12 secondary outcomes
Vasospasm changes in angiography and perfusion in CTP
Time frame: 48 hours after stimulation
Vasospasm changes in CTA and perfusion in CTP
Time frame: 48 hours after stimulation
Vasospasm changes in angiography and perfusion in CTP
Time frame: 96 hours after stimulation
Vasospasm changes in CTA and perfusion in CTP
Time frame: 96 hours after stimulation
Vasospasm changes in CTA and perfusion in CTP
Time frame: 14 days after stimulation
Vasospasm changes in angiography and perfusion in CTP
Time frame: 14 days after stimulation
Triple-H therapy
Time frame: 14 days after stimulation
Angioplasty or intra-arterial application of vasodilators
Time frame: 14 days after stimulation
Intracerebral pressure (ICP)
Time frame: Day 7- 14
Headache
Time frame: Day 7- 14
Consumption of analgesics
Time frame: Day 7- 14
Side effects of SCS
Time frame: Day 7- 14
Results and safety
The study was stopped early (reason given: Sponsor left). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Cerebral Vasospasm
Not yet recruiting
Endovascular Therapy for Cerebral Vasospasm After Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Cerebral Vasospasm After Subarachnoid Hemorrhage
Not yet recruiting
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
Not yet recruitingPhase 4
Lumbar Drain With Intrathecal Nicardipine in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage
Recruiting
The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Vasospasm, Cerebral
RecruitingObservational study
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
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.
Janine Ai Schlaeppi, MD principal investigator
Department of Neurosurgery, Inselspital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal cord stimulation in people with Cerebral Vasospasm and Subarachnoid Hemorrhage, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 19 inclusion and 11 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: stopped early, as of the sponsor's last update on 8 Jan 2026. 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 Switzerland. 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.
Are results available for this study?
The study was stopped early (reason given: Sponsor left). Results are not available in the source record.
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?
Change of baseline flow velocity (time frame: 14 days after onset vasospasm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.