Spinal Cord Stimulation for Chronic Pain

Overseen By Jon Gasson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: CereVu Medical, Inc.

Disqualifiers: Pregnancy, Psychiatric disorders, Active implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 week

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how spinal cord stimulation (SCS) affects blood flow in the brain and its relation to pain relief. Participants will wear the CereVu Device, which measures brain blood flow before, during, and after SCS use. The goal is to determine if a link exists between these measurements and the participant's pain levels. Individuals with chronic, hard-to-treat pain in their body or limbs for over six months may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new pain relief methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that the CereVu Device is safe for use in spinal cord stimulation studies?

Research shows that spinal cord stimulation (SCS) safely manages chronic pain. Although long-term data is limited, studies indicate that SCS can be effective for over two years in some individuals without major safety issues. This study uses the CereVu device, a small, wearable patch that monitors brain activity related to pain.

Available data on SCS suggests it is generally well-tolerated. However, some individuals might experience side effects, such as discomfort at the implantation site or changes in stimulation sensation. Overall, the FDA has approved SCS for other pain conditions, suggesting its safety based on existing evidence. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CereVu Device for chronic pain because it offers a unique approach to spinal cord stimulation (SCS). Unlike traditional treatments that primarily focus on masking pain signals, the CereVu Device is designed to monitor cerebral oxygenation and blood flow in real-time. This feature could provide more precise adjustments in therapy, potentially leading to better pain management outcomes. Additionally, by focusing on non-invasive monitoring, it aims to enhance patient safety and comfort, distinguishing it from other more invasive options.

What evidence suggests that the CereVu Device is effective for chronic pain?

Research has shown that spinal cord stimulation (SCS) can help manage chronic pain. Studies have found that SCS reduces pain by altering how the brain processes pain signals. One study revealed that people with chronic back and leg pain experienced significant relief after receiving SCS treatment. In this trial, the CereVu device is used alongside SCS to monitor brain blood flow and oxygen levels, aiming to better understand and track these changes. This device seeks to enhance SCS effectiveness by allowing real-time monitoring and adjustment of treatment. Overall, SCS has shown promise in effectively helping people manage chronic pain. ^{6 7 8 9 10}

Who Is on the Research Team?

Jon Gasson

Principal Investigator

CereVu

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Subject has a minimum Visual Analog Scale (VAS) score of 50 mm or higher at baseline or a 5 on a Numerical Rating Scale (NRS)

Be willing and able to comply with study-related requirements, procedures, and visits

My doctor agrees I am fit for the surgery needed in this study.

Exclusion Criteria

Subject is allergic to any adhesives, materials or fluids in or used in conjunction with the CereVu sensor

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Measurement

Objective measurements of cerebral nociceptive hemodynamic responses are obtained before spinal cord stimulation

1 week

1 visit (in-person)

Treatment

Participants undergo spinal cord stimulation while cerebral oxygenation/flow is measured

1 week

1 visit (in-person)

Follow-up

Participants are monitored for changes in cerebral nociceptive hemodynamic response and subjective pain levels after spinal cord stimulation

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CereVu Device

Trial Overview 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.

How Is the Trial Designed?

Group I: SCS Study Arm Experimental Treatment 1 Intervention

Within subject observational arm measuring non-invasive cerebral oxygenation/flow before, during and after SCS.

CereVu Device is already approved in United States for the following indications:

Approved in United States as CereVu Medical System for:

• Investigational use only, not approved for any indications

Who Is Running the Clinical Trial?

CereVu Medical, Inc.

Lead Sponsor

Trials

2

Recruited

130+

Published Research Related to This Trial

In a study of 77 patients with chronic low back and radicular pain, spinal cord stimulation showed good long-term efficacy in 63.6% of cases, indicating it can be an effective treatment for those with failed back surgery syndrome.

However, careful patient selection is crucial for success, as treatment failure occurred in 7.9% of cases, often due to complications or inappropriate selection, highlighting the importance of strict criteria for candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of chronic lumbago and radicular pain by spinal cord stimulation. Long-term results]. Hieu, PD., Person, H., Houidi, K., et al.[2006]

In a study of 254 patients undergoing spinal cord stimulation for chronic pain, 217 experienced satisfactory results, leading to permanent implantation of the device, indicating its efficacy in managing pain that doesn't respond to conventional treatments.

After an average follow-up of nearly 4 years, 68% of patients rated their pain relief as excellent to good, and 31% were able to return to work, highlighting the positive impact of spinal cord stimulation on quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of spinal cord stimulation: 10 years of experience in a pain centre in Belgium. Van Buyten, JP., Van Zundert, J., Vueghs, P., et al.[2015]

In a study of 174 patients undergoing spinal cord stimulation trials, patient-reported percentage improvement in pain was found to be higher (59%) than the calculated percentage improvement (54%), indicating a discrepancy between subjective and objective measures of pain relief.

Despite a strong correlation (0.76) between patient-reported and calculated improvements, the significant lack of agreement suggests that these two methods should not be used interchangeably for assessing outcomes in spinal cord stimulation trials, highlighting the need for better metrics in evaluating patient responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in calculated percentage improvement versus patient-reported percentage improvement in pain scores: a review of spinal cord stimulation trials. Hagedorn, JM., Deer, TR., Canzanello, NC., et al.[2021]

In a study of 320 patients treated with spinal cord stimulation devices over a follow-up period averaging 7.1 years, 52% of those with permanent implants reported at least 50% pain relief, along with improvements in daily activities and reduced use of pain medications.

The evolution from single-channel to programmable multichannel spinal cord stimulators has led to significantly lower rates of clinical and technical failures, indicating enhanced reliability and effectiveness of the newer devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic, intractable pain: experience over two decades. North, RB., Kidd, DH., Zahurak, M., et al.[2022]

A study of patients with chronic neuropathic pain who experienced loss of efficacy from spinal cord stimulation (SCS) showed significant improvements in pain intensity and quality of life after using new stimulation waveforms through implanted pulse generator adapters.

After 12 months, 81.3% of patients preferred the tonic stimulation option, indicating that these adapters could be an effective salvage solution for managing patients with decreased SCS effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Challenge of Converting "Failed Spinal Cord Stimulation Syndrome" Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study. Rigoard, P., Ounajim, A., Goudman, L., et al.[2022]

Spinal cord stimulation (SCS) is an effective surgical treatment for chronic neuropathic pain, with success rates ranging from 50-75% when performed by experienced practitioners, and is indicated for conditions like complex regional pain syndrome and diabetic neuropathy.

The procedure involves implanting leads in the spinal canal to deliver electrical currents, but it carries risks such as lead migration and infection, and its exact mechanisms of action remain only partially understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: Background and clinical application. Meier, K.[2022]

Spinal cord stimulation (SCS) has become a leading treatment for chronic neuropathic and mixed pain, with new devices and algorithms enhancing its effectiveness, particularly with high frequency and burst waveforms that do not rely on paresthesia.

A comprehensive review of studies from 2010 to 2018 shows significant advancements in SCS techniques, including burst stimulation and dorsal root ganglion stimulation, indicating improved patient outcomes and the potential for ongoing refinement in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced methods of spinal stimulation in the treatment of chronic pain: pulse trains, waveforms, frequencies, targets, and feedback loops. Maheshwari, A., Pope, JE., Deer, TR., et al.[2019]

Spinal Cord Stimulation (SCS) is highly effective for treating chronic leg pain, particularly in patients with neuropathic pain, achieving an 80% success rate in this group.

SCS is less effective for axial pain (lower back pain), indicating that its benefits are primarily seen in limb pain that cannot be treated surgically.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of chronic limb pain with spinal cord stimulation. Fogel, GR., Esses, SI., Calvillo, O.[2006]

Spinal Cord Stimulation (SCS) is increasingly used to manage severe neuropathic pain, including in rare cases like a pregnant patient with a painful thoracic arteriovenous malformation (AVM).

Using lumbar ultrasound to locate a safe site for spinal anesthesia in a patient with an SCS implant demonstrates a novel approach that can help avoid damaging the SCS electrodes during procedures like cesarean sections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Please mind the gap": successful use of ultrasound-assisted spinal anesthesia for urgent cesarean section in a patient with implanted spinal cord stimulation system for giant chest wall arteriovenous malformation - a case report. Zanfini, BA., De Martino, S., Frassanito, L., et al.[2021]

Spinal cord stimulation has become a well-established treatment for neuropathic and vasculopathic pain syndromes, particularly after other treatments have failed, with about 1700 systems implanted annually in Germany.

The therapy's introduction in Germany in the early 1970s was significantly influenced by pioneers like Jörg-Ulrich Krainick, Uwe Thoden, and Wolfhard Winkelmüller, marking a critical development in pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Development of epidural spinal cord stimulation. Fortieth anniversary of the first implantation in Germany]. Tronnier, V., Richter, HP., Winkelmüller, W.[2021]

Spinal cord stimulation (SCS) is effective in improving pain relief, sleep quality, and functional activities in patients with chronic pain, as shown by a survey of 30 patients who reported positive outcomes after receiving different SCS devices.

While there were no significant differences in pain relief and sleep improvement among the three SCS device manufacturers (Medtronic, Advanced Bionics, and ANS), the Advanced Bionics group showed less functional improvement compared to the other two groups, suggesting that device technology may influence certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. Haddadan, K., Krames, ES.[2022]

The novel closed-loop spinal cord stimulation (SCS) system effectively reduced pain intensity in patients with chronic pain, showing significant decreases from a baseline score of 8.4 to 2.0 after 12 months, with 85% patient satisfaction reported.

This real-world study involving 22 patients supports the efficacy of the ECAP-controlled SCS system, maintaining pain relief comparable to results from previous clinical trials, indicating its potential as a reliable treatment option for persistent spinal pain syndrome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Report on Real-World Outcomes with Evoked Compound Action Potential (ECAP)-Controlled Closed-Loop Spinal Cord Stimulation for Treatment of Chronic Pain. Nijhuis, HJA., Hofsté, WJ., Krabbenbos, IP., et al.[2023]

The Aarhus Neuromodulation Database has been developed to systematically collect and analyze data on spinal cord stimulation (SCS) treatments, including key parameters like pain intensity and quality of life, which can enhance the understanding and effectiveness of SCS for chronic pain.

This database is freely accessible and designed to be adaptable for various neuromodulation treatments, making it a valuable resource for both clinicians and researchers to improve patient outcomes and advance the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Aarhus Neuromodulation Database. Meier, K., Nikolajsen, L., Flink, M., et al.[2022]

In a global study involving 1881 participants, spinal cord stimulation (SCS) demonstrated a high level of safety, with a low annualized device explant rate of 3.5% and only 1.1% due to inadequate pain relief.

The most common serious adverse event was implant site infection, occurring in less than 1% of cases, indicating that SCS is generally safe for chronic pain management over a follow-up period of up to 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Rauck, RL., Loudermilk, E., Thomson, SJ., et al.[2023]

As of 2020, there are nine commonly used spinal cord stimulator (SCS) platforms from four manufacturers, highlighting the variety of options available for chronic pain management.

Understanding the unique features and specifications of each SCS device is crucial for healthcare providers to select the most appropriate hardware for optimal patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of Spinal Cord Stimulation Hardware Currently Available for the Treatment of Chronic Pain in the United States. Clingan, JA., Patel, A., Maher, DP.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06559735?draw=2&rank=1

Local Cerebral Oxygenation in Chronic Pain Patients ... Within subject observational arm measuring non-invasive cerebral oxygenation/flow before, during and after SCS. Intervention/Treatment, Device : CereVu Device.

2. withpower.com withpower.com/trial/phase-chronic-pain-7-2024-894a7

Spinal Cord Stimulation for Chronic Pain Trial Overview The study aims to observe changes in brain blood flow and oxygen levels using the CereVu sensor during different phases of spinal cord ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715925006919

Technical and Clinical Overview: Spinal Cord Stimulation These data are used to automatically adjust the stimulation intensity in real time to compensate for fluctuations in the distance between the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4121441/

Spinal Stimulation for Pain: Future Applications - PMC It evaluates the safety and effectiveness of the dedicated DRG stimulation system for the treatment of chronic lower limb pain in persons diagnosed with complex ...

5. mdpi.com mdpi.com/2077-0383/10/18/4085

Real-World Outcomes Using a Spinal Cord Stimulation ... This multicenter, observational case-series evaluated 188 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or ...

6. cerevu.com cerevu.com/technology

Technology The CereVu Medical System consists of a small, wearable, single-use patch that adheres to a patient's forehead and communicates with a reusable monitoring ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36691862/

Long-term safety of spinal cord stimulation systems in a ... Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P010032S191B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Abbott Medical spinal cord stimulation (SCS) systems are indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1526590018306813

Therapy Habituation at 12 Months: Spinal Cord Stimulation ... DRG stimulation resulted in more stable pain relief through 12-months, while tonic SCS demonstrated therapy habituation at 9- and 12-months.

10. medtronic.com medtronic.com/en-us/l/isw/spinal-cord-stimulation-indications-safety-warnings.html

Spinal Cord Stimulation - Indications, Safety, and Warnings Spinal cord stimulation (SCS) is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral ...