Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
NCT06559735 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2024-08-19
Summary
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
Conditions
Interventions
- DEVICE
-
CereVu Device
Observational, non-invasive measurements
Sponsors & Collaborators
-
CereVu Medical, Inc.
lead INDUSTRY
Principal Investigators
-
Jon Gasson · CereVu
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-13
- Primary Completion
- 2024-12-31
- Completion
- 2025-03-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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