Chronic PainNCT06559735
Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
A study testing CereVu Device in people with Chronic Pain, run by CereVu Medical, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- CereVu Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2024to 31 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age or older at the time of enrolment
- Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months
- Subject has a minimum Visual Analog Scale (VAS) score of 50 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline or a 5 on a Numerical Rating Scale (NRS)
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- Be willing and capable of giving informed consent
- Be willing and able to comply with study-related requirements, procedures, and visits
Who cannot join
- Subject is pregnant or nursing
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes
- Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)
- Have prior experience with SCS
- Be concomitantly participating in another clinical study
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- Subject has secondary gain issues that could interfere with the study measures or outcomes
- Subject is contraindicated for use of non-invasive cerebral oxygenation measurements (e.g., at risk for sensor displacement such as facial cosmetic. Non-intact skin on the forehead, or ENT surgery)
- Subject is allergic to any adhesives, materials or fluids in or used in conjunction with the CereVu sensor
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boomerang Healthcare
Walnut Creek, California, 94598
Kat Abtahi, 925-478-5488, kabtahi@boomeranghc.com
About this study
Official title: A Prospective, Observational Study Examining Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
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
- Chronic Pain
- Being tested
- CereVu Device
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CereVu DeviceDevice
Observational, non-invasive measurements
| Study group | Role | What they receive |
|---|---|---|
| SCS Study Arm | Experimental | Within subject observational arm measuring non-invasive cerebral oxygenation/flow before, during and after SCS. Receives: Device: CereVu Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Cerebral Oxygenation/Blood Flow
Opital Spectophotometry measurement from the forehead
Measured: 1 week
Numerical Pain Rating Scale (NRS)
Subjective pain 11-point pain scale
Measured: 1 week
Secondary outcomes (1)
Stress/Anxiety
Hamilton Anxiety Rating Scale
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start13 Aug 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CereVu Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Gasson, Study director, CereVu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559735
- Sponsor's protocol ID
- CIP-5005
- Status last verified
- Aug 2024
- First submitted
- 12 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study Examining Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation
- ClinicalTrials.gov ID
- NCT06559735
- Acronym / sponsor ID
- CIP-5005
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- CereVu Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 19 Aug 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 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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCS Study Arm | Experimental | Device: CereVu DeviceWithin subject observational arm measuring non-invasive cerebral oxygenation/flow before, during and after SCS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be 18 years of age or older at the time of enrolment
- Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months
- Subject has a minimum Visual Analog Scale (VAS) score of 50 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline or a 5 on a Numerical Rating Scale (NRS)
- Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
- Be willing and capable of giving informed consent
Key exclusion criteria (9 listed)
- Subject is pregnant or nursing
- Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator
- Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes
- Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)
- Have prior experience with SCS
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 |
|---|---|---|
| CereVu DeviceObservational, non-invasive measurements | Device | SCS Study Arm |
Primary outcome
Regional Cerebral Oxygenation/Blood Flow
Time frame: 1 week
Opital Spectophotometry measurement from the forehead
Numerical Pain Rating Scale (NRS)
Time frame: 1 week
Subjective pain 11-point pain scale
1 secondary outcome
Stress/Anxiety
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Jon Gasson study director
CereVu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CereVu Device in people with Chronic Pain, run by CereVu Medical, Inc. 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 9 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: status not confirmed, as of the sponsor's last update on 19 Aug 2024. 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. 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?
Contact Jon Gasson (415-233-2119, jgasson@cerevu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional Cerebral Oxygenation/Blood Flow (time frame: 1 week). The study lists 2 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 19 Aug 2024; AzTrials last refreshed its copy on 6 Nov 2026.