Spinal Cord Stimulation for Chronic Pain

Recruiting in Walnut Creek (>99 mi)

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

Trial Summary

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 data supports the effectiveness of the treatment CereVu Device, CereVu Medical System, CereVu Sensor, ROPA System for chronic pain?

Research on spinal cord stimulation, a similar treatment, shows it can be effective for chronic pain relief. In one study, 68% of patients reported good to excellent results, and another study found 52% of patients experienced at least 50% pain relief over seven years. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for treating chronic pain?

Research shows that spinal cord stimulation is generally safe for treating chronic pain, with a low rate of device removal and serious side effects. In a study of over 1,200 patients, less than 1% experienced serious issues like implant site infection. ^{6 7 8 9 10}

How is the CereVu Device treatment for chronic pain different from other treatments?

The CereVu Device, used for spinal cord stimulation, is unique because it involves implanting leads in the spinal canal to deliver electrical currents, which can be adjusted with advanced programming for personalized pain relief. This method is distinct from traditional pain treatments as it directly targets the spinal cord to manage chronic pain, offering a customizable approach that can be more effective for certain types of pain. ^{11 12 13 14 15}

What is the purpose of this trial?

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

Research Team

Jon Gasson

Principal Investigator

CereVu

Eligibility Criteria

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

Be concomitantly participating in another clinical study

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Treatment of chronic lumbago and radicular pain by spinal cord stimulation. Long-term results]. [2006]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of spinal cord stimulation: 10 years of experience in a pain centre in Belgium. [2015]

3. England 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic, intractable pain: experience over two decades. [2022]

5. Switzerland 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. [2022]

6. United States 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. [2022]

7. New Zealand 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The Aarhus Neuromodulation Database. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Survey of Spinal Cord Stimulation Hardware Currently Available for the Treatment of Chronic Pain in the United States. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Advanced methods of spinal stimulation in the treatment of chronic pain: pulse trains, waveforms, frequencies, targets, and feedback loops. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Management of chronic limb pain with spinal cord stimulation. [2006]

14. England 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. [2021]

15. Germany pubmed.ncbi.nlm.nih.gov

[Development of epidural spinal cord stimulation. Fortieth anniversary of the first implantation in Germany]. [2021]