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Behavioural Intervention

Spinal Cord Stimulation for Chronic Pain

N/A
Recruiting
Research Sponsored by CereVu Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 18 years of age or older at the time of enrolment
Be willing and capable of giving informed consent
Must not have
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
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week
Awards & highlights

Summary

This trial aims to understand how spinal cord stimulation affects brain responses to pain. Researchers will use a sensor and system to measure these responses and compare them to how patients report their pain levels. Special algorithms will

Who is the study for?
This trial is for chronic pain patients interested in how spinal cord stimulation (SCS) affects brain blood flow and oxygen related to pain. Participants should be eligible for SCS therapy, able to give informed consent, and willing to undergo measurements with the CereVu device.
What is being tested?
The study aims to observe changes in brain blood flow and oxygen levels using the CereVu sensor during different phases of spinal cord stimulation therapy. It will compare these objective data with patients' reports of their pain levels.
What are the potential side effects?
Since this trial focuses on monitoring rather than treatment, side effects are minimal but may include discomfort at the sensor attachment site or anxiety from being part of a clinical study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am willing and able to give my consent for treatment.
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I have had severe, ongoing pain in my body for over 6 months that hasn’t improved with treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have a mental health condition that affects my perception of pain or treatment.
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I cannot use non-invasive brain oxygen level monitors due to risks like recent facial surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Numerical Pain Rating Scale (NRS)
Regional Cerebral Oxygenation/Blood Flow
Secondary study objectives
Stress/Anxiety

Trial Design

1Treatment groups
Experimental Treatment
Group I: SCS Study ArmExperimental Treatment1 Intervention
Within subject observational arm measuring non-invasive cerebral oxygenation/flow before, during and after SCS.

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Who is running the clinical trial?

CereVu Medical, Inc.Lead Sponsor
1 Previous Clinical Trials
100 Total Patients Enrolled
Jon GassonStudy DirectorCereVu
~17 spots leftby Dec 2024
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