Neuromodulation for Chronic Pain

Overseen By Fady Girgis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alberta Health Services, Calgary

Disqualifiers: Non-English speaking

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of different types of neuromodulation, which uses electrical signals to alter nerve activity, in treating chronic pain. Participants will receive either standard stimulation or an experimental type. It is ideal for individuals approved for a neuromodulation device implant to manage chronic pain. Those who meet the criteria might consider this trial to explore new pain management strategies. As an unphased trial, it offers a unique opportunity to contribute to innovative research in pain management.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these stimulation paradigms are safe for treating chronic pain?

Research shows that treatments using neuromodulation for chronic pain are usually well-tolerated. Studies on similar devices using electrical stimulation, like those in this trial, indicate they are generally safe. For instance, researchers have tested the Abbott implantable neurostimulation system for safety and effectiveness, providing a good example of these treatments.

While the specific settings tested in this trial aren't detailed, past research suggests that neuromodulation can accurately target pain areas. This precision might lead to fewer side effects compared to less precise treatments. However, every medical procedure carries risks, so discussing these with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the neuromodulation techniques being tested for chronic pain because they offer a fresh approach to pain management. Unlike traditional treatments, which often rely on medications like opioids or NSAIDs, these techniques use electrical stimulation to modulate nerve activity. The experimental stimulation settings are designed to fine-tune this electrical modulation in ways that could provide pain relief without the side effects associated with drugs. This innovative approach could lead to more personalized and effective pain management strategies, reducing the dependency on medication.

What evidence suggests that these stimulation paradigms could be effective for chronic pain?

Research shows that using electrical stimulation to manage pain, known as neuromodulation, may help relieve chronic pain. This trial will compare different stimulation settings. Participants in one arm will receive industry-standard stimulation, while those in another arm will receive experimental stimulation settings. Studies have found that accurately targeting painful areas can improve pain control and reduce side effects. For example, one study found that using transcutaneous electrical nerve stimulation (TENS) had positive effects on pain after a spinal cord injury. Another study showed that targeting specific nerves with peripheral nerve stimulation significantly reduced pain. While results can vary, these findings suggest that neuromodulation might offer relief for those dealing with chronic pain. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals who experience chronic pain and are candidates for a neuromodulation device implant, which they have agreed to receive. Participants must be able to communicate in English.

Inclusion Criteria

You are planning to have a neuromodulation device implanted and have already agreed to it.

Exclusion Criteria

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neuromodulation treatment using various stimulation paradigms in a blinded fashion

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Stimulation parameters

Trial Overview The study aims to test the effectiveness of different stimulation settings on a neuromodulation device that's implanted in patients with chronic pain conditions.

How Is the Trial Designed?

Group I: Industry standard stimulation Active Control 1 Intervention

Industry standard stimulation settings

Group II: Experimental stimulation Placebo Group 1 Intervention

Experimental stimulation settings

Stimulation parameters is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Electrical Stimulation Therapy for:

• Chronic Pain Management
• Muscle Rehabilitation
• Neurological Disorders

Approved in European Union as Neuromodulation Therapy for:

• Chronic Pain Relief
• Muscle Stimulation
• Neurological Rehabilitation

Approved in Canada as Stimulation Therapy for:

• Pain Management
• Muscle Recovery
• Neurological Conditions

Who Is Running the Clinical Trial?

Alberta Health Services, Calgary

Lead Sponsor

Trials

15

Recruited

2,600+

Published Research Related to This Trial

The study identified 13 product codes for 8 types of neuromodulation devices, revealing a wealth of preclinical safety data from various animal models, which is crucial for understanding the effects of electrical neurostimulation.

Analysis of the data suggests that existing feline cortical models may not be suitable for evaluating tissue damage in peripheral nerve and spinal cord stimulation, highlighting the need for more relevant animal models in safety assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public Regulatory Databases as a Source of Insight for Neuromodulation Devices Stimulation Parameters. Kumsa, D., Steinke, GK., Molnar, GF., et al.[2022]

Neurostimulation techniques, such as spinal cord stimulation and deep brain stimulation, offer a non-destructive and adjustable method for treating chronic pain, contrasting with older ablative techniques that often provided only temporary relief.

These modern neurostimulation approaches allow for tailored electrical current delivery, which can adapt to the dynamic nature of chronic pain conditions, potentially leading to more effective and long-lasting outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of chronic pain with neurostimulation. Birknes, JK., Sharan, A., Rezai, AR.[2019]

The Vectors study demonstrated that a standardized approach to spinal cord stimulation (SCS) using 1 kHz stimulation significantly reduced overall pain by an average of 45.4 mm on the visual analogue scale (VAS) at three months, with sustained results through 12 months.

At the 12-month mark, 79% of participants experienced at least a 50% improvement in pain, and 85% reported satisfaction with the therapy, indicating that this method not only alleviates pain but also enhances quality of life and functional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study. Hatheway, JA., Mangal, V., Fishman, MA., et al.[2023]

Chronic pain affects around 100 million adults in the US, and current neuropharmacology and neurostimulation therapies often have limited effectiveness and unclear mechanisms of action.

The study developed a simulation model that reveals how electrical neurostimulation interacts with sensory nerve activity, showing that higher stimulation frequencies can reduce the reliability of sensory signals, which may help improve our understanding of pain modulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical neurostimulation for chronic pain: On selective relay of sensory neural activities in myelinated nerve fibers. Sacré, P., Sarma, SV., Guan, Y., et al.[2020]

In a pilot study involving 31 participants with chronic intractable pain, a novel neurostimulation waveform (anatomical pulsed stimulation, aPSP) significantly reduced pain more effectively than traditional spinal cord stimulation (T-SCS), with a 60% reduction in back pain and 63% in leg pain compared to 46% and 43% respectively for T-SCS.

The aPSP approach not only showed higher responder rates (61% for back pain and 78% for leg pain) but also suggests a multimechanistic action by targeting specific neural pathways, indicating its potential as an effective treatment for chronic pain, although further studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Pulsed Stimulation Pattern in Spinal Cord Stimulation: Clinical Results and Postulated Mechanisms of Action in the Treatment of Chronic Low Back and Leg Pain. Desai, MJ., Salmon, J., Verrills, P., et al.[2023]

Recent advancements in understanding how pain is transmitted and modulated have led to new surgical options for managing chronic pain, particularly for cases that do not respond to traditional treatments.

Neurostimulation techniques, such as spinal cord stimulation and deep brain stimulation, can effectively activate the body's pain modulation network, offering a promising approach for treating chronic pain that is difficult to control with medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromodulation techniques for medically refractory chronic pain. Landau, B., Levy, RM.[2022]

A large prospective study on spinal stimulating electrodes revealed that the technical grade of a stimulator is directly related to its range of stimulation for pain treatment.

The study statistically compared various stimulus parameters, including phase, polarity, and orientation of bipolar electrodes, indicating that these factors significantly influence the effectiveness of pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal stimulation: statistical superiority of monophasic stimulation of narrowly separated, longitudinal bipoles having rostral cathodes. Law, JD.[2019]

The evaluation of three electrostimulators revealed that at least two measured parameters for each device were not within 25% of the manufacturer's claimed values, indicating a need for calibration to ensure accurate output.

While some pulse voltages exceeded safety standards for long-term use, short-term clinical use may still be safe; however, practitioners must be trained to use these devices properly to avoid potential tissue damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrostimulators for acupuncture: safety issues. Lytle, CD., Thomas, BM., Gordon, EA., et al.[2004]

Electrical stimulation of the motor cortex using different electrode polarities (anode, cathode, or bipole) significantly affects how neural elements respond, with anodal stimulation favoring perpendicular excitation and cathodal stimulation favoring parallel excitation.

The study's modeling approach reveals that the position and polarity of electrodes can optimize chronic pain management therapies by influencing the excitation thresholds of cortical neurons, potentially leading to more effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anodal vs cathodal stimulation of motor cortex: a modeling study. Manola, L., Holsheimer, J., Veltink, P., et al.[2023]

This manuscript introduces a new electrical definition of therapeutic dose for spinal cord stimulation (SCS) aimed at treating chronic pain, which is essential for establishing reliable dose-response relationships in neuromodulation therapies.

The proposed definition enhances the understanding of SCS's mechanism of action and suggests methods for personalizing and standardizing treatment doses, potentially improving the acceptance of SCS compared to traditional pharmacological treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures of Dosage for Spinal-Cord Electrical Stimulation: Review and Proposal. Single, PS., Scott, JB., Mugan, D.[2023]

External electrical stimulation effectively controls acute pain in approximately 80% of patients, making it a promising option for immediate pain relief.

For chronic pain, however, only about 25% of patients experience significant relief from this method, suggesting the need for a more comprehensive treatment approach that includes therapies like operant conditioning and physical exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The viability of external electrical stimulation as a therapeutic modality. Shealy, CN.[2011]

The study evaluated the effects of different electrical stimulation techniques on pain relief using the nociceptive RIII reflex in 24 healthy volunteers, revealing that non-noxious TENS provided temporary relief, while noxious TENS produced both immediate facilitation and significant inhibitory after-effects.

The piezo-electric current (PECs1) demonstrated powerful and long-lasting pain relief effects, particularly when applied to areas away from the pain site, suggesting its potential as a clinically effective treatment for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Depressive effects of segmental and heterotopic application of transcutaneous electrical nerve stimulation and piezo-electric current on lower limb nociceptive flexion reflex in human subjects. Danziger, N., Rozenberg, S., Bourgeois, P., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10616008/

Do Electrical Stimulation Devices Reduce Pain and ... Meta-analyses reported that TENS negligibly improved symptoms of chronic back pain relative to control treatments, but was less effective than ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666379124005342

The evolving landscape of neuromodulation for pain care Here, we present five different insights on the use of neuromodulation strategies for effective pain management in clinical practice.

3. aetna.com aetna.com/cpb/medical/data/1_99/0011.html

Electrical Stimulation for Pain - Medical Clinical Policy ... Trial of percutaneous stimulation was successful (resulting in at least a 50 % reduction in pain for a minimum of 3 days). Note: If a peripheral nerve ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11705683

Neuromodulation in chronic pain management It allows for more precise targeting of pain areas, leading to potentially greater pain relief, fewer side effects, and lower variability in ...

5. nature.com nature.com/articles/s41393-022-00776-z

Efficacy of transcutaneous electrical nerve stimulation in ... Transcutaneous electrical nerve stimulation has some clinical therapeutic effects on persons with pain after spinal cord injury.

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

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The safety and effectiveness of the Abbott implantable neurostimulation system to treat. NSBP is based on the Abbott sponsored prospective, multicenter, ...