Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

Part of paid clinical trials in Walnut Creek, California.

Sponsor
CereVu Medical, Inc.
Study ID
NCT06559735
Status
Recruiting
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Conditions

  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CereVu Device — DEVICE
    Observational, non-invasive measurements

Study Details

The primary objective of the study is to determine changes in cerebral nociceptive hemodynamic response (blood oxygenation/flow) before, during and following spinal cord stimulation (SCS). Objective measurements of cerebral nociceptive hemodynamic responses will be obtained with the CereVu sensor and ROPA system and will be analyzed offline and compared against subjective measures of pain. Proprietary analysis algorithms will be incorporated and developed to understand how the objective measurements correlate with subject reported pain levels

Key Dates

Start date
Aug 13, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2024
Completion
Mar 31, 2025

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: SCS Study Arm
    Within subject observational arm measuring non-invasive cerebral oxygenation/flow before, during and after SCS.

Primary Outcome Measure

Regional Cerebral Oxygenation/Blood Flow [ Time Frame: 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boomerang HealthcareWalnut CreekCalifornia94598
Kat Abtahi
[email protected]
925-478-5488

Find similar trials in Walnut Creek, CA

By research site
Boomerang Healthcare· Walnut Creek, CA

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