Trials / Recruiting
RecruitingNCT06559735
Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
A Prospective, Observational Study Examining Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- CereVu Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | CereVu Device | Observational, non-invasive measurements |
Timeline
- Start date
- 2024-08-13
- Primary completion
- 2024-12-31
- Completion
- 2025-03-31
- First posted
- 2024-08-19
- Last updated
- 2024-08-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06559735. Inclusion in this directory is not an endorsement.