20 Participants Needed

Neuromodulation for Chronic Pain

FG
Overseen ByFady Girgis, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Alberta Health Services, Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment for chronic pain?

Research shows that electrical stimulation, a key part of neuromodulation, can help manage chronic pain by activating the body's pain modulation network. While it may not provide significant relief for all patients, it has been effective in some cases, and combining it with other therapies might improve outcomes.12345

Is neuromodulation for chronic pain generally safe for humans?

Research indicates that a wide range of stimulation parameters used in neuromodulation are considered safe, and studies have shown that these treatments can be safely incorporated into standard practice. However, it is important for devices to be properly calibrated and for practitioners to be trained to ensure safe use.678910

How is the treatment of chronic pain with neuromodulation different from other treatments?

Neuromodulation for chronic pain is unique because it uses electrical stimulation to modulate the nervous system, offering a non-destructive and reversible approach that can be adjusted over time. Unlike traditional methods that may involve surgery or medication, this treatment can be tailored to the patient's evolving condition, providing a more resilient and adaptable solution.2451112

What is the purpose of this trial?

The objective of this study is to determine the efficacy of neuromodulation using various stimulation paradigms in the treatment of several disorders including chronic pain.

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Industry standard stimulationActive Control1 Intervention
Industry standard stimulation settings
Group II: Experimental stimulationPlacebo Group1 Intervention
Experimental stimulation settings

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

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Approved in United States as Electrical Stimulation Therapy for:
  • Chronic Pain Management
  • Muscle Rehabilitation
  • Neurological Disorders
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Approved in European Union as Neuromodulation Therapy for:
  • Chronic Pain Relief
  • Muscle Stimulation
  • Neurological Rehabilitation
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Approved in Canada as Stimulation Therapy for:
  • Pain Management
  • Muscle Recovery
  • Neurological Conditions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alberta Health Services, Calgary

Lead Sponsor

Trials
15
Recruited
2,600+

Findings from Research

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.
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]
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.
Anodal vs cathodal stimulation of motor cortex: a modeling study.Manola, L., Holsheimer, J., Veltink, P., et al.[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.
The viability of external electrical stimulation as a therapeutic modality.Shealy, CN.[2011]

References

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. [2019]
Anodal vs cathodal stimulation of motor cortex: a modeling study. [2023]
The viability of external electrical stimulation as a therapeutic modality. [2011]
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. [2023]
Neuromodulation techniques for medically refractory chronic pain. [2022]
Spinal stimulation: statistical superiority of monophasic stimulation of narrowly separated, longitudinal bipoles having rostral cathodes. [2019]
Measures of Dosage for Spinal-Cord Electrical Stimulation: Review and Proposal. [2023]
Electrostimulators for acupuncture: safety issues. [2004]
Long-Term Efficacy of a Novel Spinal Cord Stimulation Clinical Workflow Using Kilohertz Stimulation: Twelve-Month Results From the Vectors Study. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
Public Regulatory Databases as a Source of Insight for Neuromodulation Devices Stimulation Parameters. [2022]
Treatment of chronic pain with neurostimulation. [2019]
12.United Statespubmed.ncbi.nlm.nih.gov
Electrical neurostimulation for chronic pain: On selective relay of sensory neural activities in myelinated nerve fibers. [2020]
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