An interventional study of Spinal cord stimulation in Cerebral Vasospasm and Subarachnoid Hemorrhage, sponsored by Insel Gruppe AG, University Hospital Bern. Terminated at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Treatment
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.
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.
77 studies on the registry are indexed under Vasospasm, Intracranial; 15 are open to participants now.
This study's enrollment of 1 is below the median of 25 across 51 interventional studies indexed under Vasospasm, Intracranial.
Browse Vasospasm, Intracranial studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cerebral vasospasm:
Cerebral angiography
o Narrowing of vessel lumen > 66%
Transcranial Doppler ultrasound
Intracranial CT angiography
o Narrowing of vessel lumen > 66%
Exclusion Criteria:
Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH
Device: Spinal cord stimulation
Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH
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.
Time frame: 14 days after onset vasospasm
Vasospasm changes in angiography and perfusion in CTP
Vasospasm changes in angiography and perfusion in CTP
Time frame: 48 hours after stimulation
Vasospasm changes in CTA and perfusion in CTP
Vasospasm changes in CTA and perfusion in CTP
Time frame: 48 hours after stimulation
Vasospasm changes in angiography and perfusion in CTP
Vasospasm changes in angiography and perfusion in CTP
Time frame: 96 hours after stimulation
Vasospasm changes in CTA and perfusion in CTP
Vasospasm changes in CTA and perfusion in CTP
Time frame: 96 hours after stimulation
Vasospasm changes in CTA and perfusion in CTP
Vasospasm changes in CTA and perfusion in CTP
Time frame: 14 days after stimulation
Vasospasm changes in angiography and perfusion in CTP
Vasospasm changes in angiography and perfusion in CTP
Time frame: 14 days after stimulation
Triple-H therapy
Development of symptomatic vasospasm from onset to day 14 with need for Triple-H therapy
Time frame: 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
Time frame: 14 days after stimulation
Intracerebral pressure (ICP)
Intracerebral pressure (ICP)
Time frame: Day 7- 14
Headache
Headache measured by VAS Scale (Score 0-10 with 0 representing no pain, and 10 maximum pain intensity)
Time frame: Day 7- 14
Consumption of analgesics
Consumption of analgesics
Time frame: Day 7- 14
Side effects of SCS
Side effects of SCS
Time frame: Day 7- 14
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Insel Gruppe AG, University Hospital Bern