NCT05150002

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

June 30, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2026

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

2.5 years

First QC Date

November 15, 2021

Last Update Submit

January 6, 2026

Conditions

Cerebral VasospasmSubarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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.

    14 days after onset vasospasm

Secondary Outcomes (12)

  • Vasospasm changes in angiography and perfusion in CTP

    48 hours after stimulation

  • Vasospasm changes in CTA and perfusion in CTP

    48 hours after stimulation

  • Vasospasm changes in angiography and perfusion in CTP

    96 hours after stimulation

  • Vasospasm changes in CTA and perfusion in CTP

    96 hours after stimulation

  • Vasospasm changes in CTA and perfusion in CTP

    14 days after stimulation

  • +7 more secondary outcomes

Study Arms (1)

Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH

EXPERIMENTAL

Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH

Device: Spinal cord stimulation

Interventions

Spinal cord stimulationDEVICE

Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH

Cervical spinal cord stimulation on cerebral vasospasm after aneurysmal SAH

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%
  • 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
  • +4 more criteria

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Neurosurgery, Bern University Hospital

Bern, 3000, Switzerland

Location

MeSH Terms

Conditions

Vasospasm, IntracranialSubarachnoid Hemorrhage

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Janine Ai Schlaeppi, MD

    Department of Neurosurgery, Inselspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 15, 2021

First Posted

December 8, 2021

Study Start

June 30, 2023

Primary Completion

December 12, 2025

Study Completion

January 6, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)