The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06443177
Status
Not Yet Recruiting

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Conditions

  • Aneurysmal Subarachnoid Hemorrhage
  • Vasospasm, Cerebral

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Vectris trial leads and stimulation — DEVICE
    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.
  • Sham — DEVICE
    No electrode is placed.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jul 2025
Primary completion
Mar 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Spinal Cord Stimulation
    Participants randomized to receive temporary electrode inserted through the skin into the epidural space of participants upper back/lower neck.
  • Sham Comparator: Sham Comparator
    Participants randomized to not receive temporary electrode.

Primary Outcome Measure

Pre-Cerebrovascular response - Velocity [ Time Frame: Day 1 - Day 14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-

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By research site
University of Alabama at Birmingham· Birmingham, AL

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