Vasospasm, CerebralNCT06443177
The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
A study testing Vectris trial leads and stimulation in people with Vasospasm, Cerebral and Aneurysmal Subarachnoid Hemorrhage, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of the study is to see that in addition to existing therapy, how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vasospasm, Cerebral, Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Vectris trial leads and stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2028to 31 Jul 2031
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage (1)
- Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage
- For females of reproductive potential: Negative pregnancy test at time of treatment
- Plan to undergo standard of care and follow-up
Who cannot join
- Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5)
- Does not provide consent for the procedure.
- Posterior circulation aneurysmal subarachnoid hemorrhage.
- Initial aneurysm treatment after post bleed day 1
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
The purpose of the study is to see that in addition to existing therapy, how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture.
Read the detailed description
The Investigators' overarching hypothesis is that sympathetic innervation plays a substantial role in conferring cerebral vasospasm (CVS) risk to aneurysmal subarachnoid hemorrhage (aSAH) patients and is associated with severity of clinical features and outcomes. Specifically, the Investigators surmise that central (hypothalamic) and local (arterial adventitia) sympathetic inputs are upregulated following SAH and integrate at the level of the neuromuscular junction to abnormally increase cerebrovascular tone. The long-term goal of this program is to use orthogonal approaches to undertake a comprehensive electrophysiological, functional genomics, and advanced imaging analysis of CVS. The Investigators hope is these data inform therapeutic pathways to modulate implicated pathogenic mechanisms and reduce CVS incidence and severity, thereby improving overall clinical outcomes in aSAH. In the short-term, the Investigators will focus on elucidating the modulatory role of cervical spinal cord stimulator (SCS) on sympathetic innervation to the cerebral vasculature.
This is a Phase 2 prospective, randomized single center study assessing the safety and efficacy of SCS for reducing vasospasm. aSAH patients who meet inclusion criteria and provide informed consent will be randomly assigned to SCS or a sham procedure. Subjects will be blinded until the end of the study, with no allowance for crossover. Temporary leads will stimulate, utilizing a paradigm established from prior human studies and the effect measured with daily transcranial doppler (TCD). Leveraging prior experience in vascular and functional neurosurgery, the Investigators' group is poised to make a substantial impact. Below the Investigators outline a feasible framework to modulate sympathetic drivers of CVS.
Aim 1: Perform feasibility analysis of SCS placement and operation in the aSAH setting. It is presently unknown how temporary SCS will impact the workflow and care of patients with acutely ruptured cerebral aneurysms. Given the rate of new aSAH cases at the Investigators' center (~50 per year), initiation of prospective data collection and longitudinal study are required. The Investigators will comprehensively assess operative time for electrode implantation, lead function and data transmission efficiency in the ICU, site infection/pressure injury and untoward systemic effects (hypotension, arrhythmia) for all patients enrolled at the Investigators' center.
Aim 2: Quantify the sympathetic modulating effect of SCS on cerebral blood flow during CVS. Further characterization of the sympathetic contribution to CVS will establish a rationale for functional/neuromodulatory therapies such as SCS. The Investigators will perform cervical epidural stimulation through temporary leads and monitor effects on cerebral blood flow by daily TCD. Experiments will continue throughout the 14-day CVS window to capture longitudinal changes in sympathetic tone and vascular response. Quantitative TCD metrics (velocity, resistance, Lindegaard ratio) will be compared between on- and off-stimulation epochs. The Investigators' study will not only fundamentally advance the Investigators' understanding of vasospasm, but also provide a framework to elucidate mechanisms of other cerebrovascular conditions.
- Being tested
- Vectris trial leads and stimulation, Sham
- Keywords
- aSAH, CVS, Sympathetic Modulation, Ruptured brain aneurysm
- 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.
Vectris trial leads and stimulationDevice
The electrode is placed into the epidural space using standard epidural placement techniques with paramedian approach. The initial electrode settings have been adopted from prior studies. Should any significant discomfort be elicited from the stimulation, first the amplitude will be decreased to an acceptable level. If an acceptable level of stimulation is unable to be found, the stimulation will be discontinued.
ShamDevice
No electrode is placed.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Participants randomized to receive temporary electrode inserted through the skin into the epidural space of participants upper back/lower neck. Receives: Device: Vectris trial leads and stimulation |
| Sham Comparator | Sham comparator | Participants randomized to not receive temporary electrode. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-Cerebrovascular response - Velocity
Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Measured: Day 1 - Day 14
Pre-Cerebrovascular response - Resistance
Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Measured: Day 1 - Day 14
Pre-Cerebrovascular response - Lindegaard ratio
Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Measured: Day 1 - Day 14
Post-Cerebrovascular response - Velocity
Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Measured: Day 1 - Day 14
Post-Cerebrovascular response - Resistance
Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Measured: Day 1 - Day 14
Post-Cerebrovascular response - Lindegaard ratio
Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Measured: Day 1 - Day 14
Transcranial Doppler (TCD) velocities of cerebral arteries
Daily transcranial Doppler studies will be performed to obtain quantitative data on cerebrovascular response during the critical 14-day vasospasm window.
Measured: Day 1 - Day 14
Secondary outcomes (1)
Overall Survival
Overall survival is defined for all patients and measured from time of treatment to death or end of a study. The analyses for overall survival will be like that of the primary endpoint. It will also utilize Kaplan Meier methods and Cox proportional hazards modeling to compare the overall survival to the treatment-dependent prognosis index.
Measured: Through study completion, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start31 Jul 2028 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2031 (estimated)
Why it stopped: Pending IDE
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasospasm, CerebralStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse G. A. Jones, MD, University of Alabama at Birmingham
- Investigators
- Jesse Jones, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443177
- Sponsor's protocol ID
- IRB-300012920
- Other IDs
- UAB
- Status last verified
- Sep 2026
- First submitted
- 6 May 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT06443177
- Acronym / sponsor ID
- IRB-300012920
- Keywords
- aSAH, CVS, Sympathetic Modulation, Ruptured brain aneurysm
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Pending IDE
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 31 Jul 2028 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 5 Jun 2024 (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.
The purpose of the study is to see that in addition to existing therapy, how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture.
Detailed description
The Investigators' overarching hypothesis is that sympathetic innervation plays a substantial role in conferring cerebral vasospasm (CVS) risk to aneurysmal subarachnoid hemorrhage (aSAH) patients and is associated with severity of clinical features and outcomes. Specifically, the Investigators surmise that central (hypothalamic) and local (arterial adventitia) sympathetic inputs are upregulated following SAH and integrate at the level of the neuromuscular junction to abnormally increase cerebrovascular tone. The long-term goal of this program is to use orthogonal approaches to undertake a comprehensive electrophysiological, functional genomics, and advanced imaging analysis of CVS. The Investigators hope is these data inform therapeutic pathways to modulate implicated pathogenic mechanisms and reduce CVS incidence and severity, thereby improving overall clinical outcomes in aSAH. In the short-term, the Investigators will focus on elucidating the modulatory role of cervical spinal cord stimulator (SCS) on sympathetic innervation to the cerebral vasculature.
This is a Phase 2 prospective, randomized single center study assessing the safety and efficacy of SCS for reducing vasospasm. aSAH patients who meet inclusion criteria and provide informed consent will be randomly assigned to SCS or a sham procedure. Subjects will be blinded until the end of the study, with no allowance for crossover. Temporary leads will stimulate, utilizing a paradigm established from prior human studies and the effect measured with daily transcranial doppler (TCD). Leveraging prior experience in vascular and functional neurosurgery, the Investigators' group is poised to make a substantial impact. Below the Investigators outline a feasible framework to modulate sympathetic drivers of CVS.
Aim 1: Perform feasibility analysis of SCS placement and operation in the aSAH setting. It is presently unknown how temporary SCS will impact the workflow and care of patients with acutely ruptured cerebral aneurysms. Given the rate of new aSAH cases at the Investigators' center (~50 per year), initiation of prospective data collection and longitudinal study are required. The Investigators will comprehensively assess operative time for electrode implantation, lead function and data transmission efficiency in the ICU, site infection/pressure injury and untoward systemic effects (hypotension, arrhythmia) for all patients enrolled at the Investigators' center.
Aim 2: Quantify the sympathetic modulating effect of SCS on cerebral blood flow during CVS. Further characterization of the sympathetic contribution to CVS will establish a rationale for functional/neuromodulatory therapies such as SCS. The Investigators will perform cervical epidural stimulation through temporary leads and monitor effects on cerebral blood flow by daily TCD. Experiments will continue throughout the 14-day CVS window to capture longitudinal changes in sympathetic tone and vascular response. Quantitative TCD metrics (velocity, resistance, Lindegaard ratio) will be compared between on- and off-stimulation epochs. The Investigators' study will not only fundamentally advance the Investigators' understanding of vasospasm, but also provide a framework to elucidate mechanisms of other cerebrovascular conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Device: Vectris trial leads and stimulationParticipants randomized to receive temporary electrode inserted through the skin into the epidural space of participants upper back/lower neck. |
| Sham Comparator | Sham comparator | Device: ShamParticipants randomized to not receive temporary electrode. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage (1)
- Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage
- For females of reproductive potential: Negative pregnancy test at time of treatment
Key exclusion criteria (4 listed)
- Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5)
- Does not provide consent for the procedure.
- Posterior circulation aneurysmal subarachnoid hemorrhage.
- Initial aneurysm treatment after post bleed day 1
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 |
|---|---|---|
| Vectris trial leads and stimulationThe electrode is placed into the epidural space using standard epidural placement techniques with paramedian approach. The initial electrode settings have been adopted from prior studies. Should any significant discomfort be elicited from the stimulation, first the amplitude will be decreased to an acceptable level. If an acceptable level of stimulation is unable to be found, the stimulation will be discontinued. | Device | Spinal Cord Stimulation |
| ShamNo electrode is placed. | Device | Sham Comparator |
Primary outcome
Pre-Cerebrovascular response - Velocity
Time frame: Day 1 - Day 14
Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Pre-Cerebrovascular response - Resistance
Time frame: Day 1 - Day 14
Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Pre-Cerebrovascular response - Lindegaard ratio
Time frame: Day 1 - Day 14
Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Post-Cerebrovascular response - Velocity
Time frame: Day 1 - Day 14
Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Post-Cerebrovascular response - Resistance
Time frame: Day 1 - Day 14
Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Post-Cerebrovascular response - Lindegaard ratio
Time frame: Day 1 - Day 14
Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.
Transcranial Doppler (TCD) velocities of cerebral arteries
Time frame: Day 1 - Day 14
Daily transcranial Doppler studies will be performed to obtain quantitative data on cerebrovascular response during the critical 14-day vasospasm window.
1 secondary outcome
Overall Survival
Time frame: Through study completion, approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
Jesse Jones, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vectris trial leads and stimulation in people with Vasospasm, Cerebral and Aneurysmal Subarachnoid Hemorrhage, run by University of Alabama at Birmingham 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 6 inclusion and 4 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: paused, as of the sponsor's last update on 24 Sep 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 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. Some participants in this study may receive a placebo. 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?
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?
Pre-Cerebrovascular response - Velocity (time frame: Day 1 - Day 14). The study lists 7 primary outcomes in all. 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 24 Sep 2026.