Clinical Evidence

    Research & Evidence

    Advancing the science of neuromodulation for painful diabetic neuropathy through rigorous clinical research.

    Read the NS100 clinical research abstracts

    Active Clinical Studies

    We are committed to building the evidence base for NeuroDynamics Global therapy through well-designed clinical trials.

    Presented

    Double-Blind, Randomized, Placebo-Controlled Trial

    Presented at North American Neuromodulation Society (NAMS), S. Madhuchander, S. Gurunath (January 2019)

    Enrolled 89 subjects with peripheral neuropathy caused by type 2 diabetes. Patients receiving neurostimulation treatment (fixed and sweep frequency) demonstrated a statistically significant decrease in pain (VAS), with simultaneous improvement in nerve sensory function (VPT), patient function (ONLS), and anxiety/sleep scores (p<.001). Results suggest the effects are reproducible and directly attributable to the neurostimulation treatment.

    Key Outcome: 68.25% of subjects receiving stimulation showed significant pain reduction

    Published

    Observational Trial — Frontiers in Neuroscience (August 2025)

    Staats, P. S. et al.

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    Statistical analysis of 83 patients over an average of 227 days. Within 90 days, mean NRS pain scores decreased from 7.92 to 1.04 and mean glucose normalized from 209 to 121 mg/dL. Both endpoints were maintained for an average of 7.85 months. In a subset of 45 patients, 80% reported discontinuing all pain and diabetes medications.

    Key Outcome: Pain reduction maintained for 7.85 months; 80% stopped all pain & diabetes medications

    Staats, P. S., Staats, A., Mikhaiel, B., Chen, J., Azabou, E., & Rangon, C.-M. (2025). Frontiers in Neuroscience, vol. 19, article 1644961.

    NRS Pain Score Values — 87% Reduction in 90 Days
    Blood Glucose Level — 37% Reduction in 90 Days
    Recruiting

    Multi-Center, Prospective, Open-Label, Observational Study

    Cleveland Clinic (National Principal Investigator) and Partner Sites

    Cleveland Clinic

    An approximately 6-month study consisting of about 9 study visits evaluating the reduction of diabetic neuropathic pain for subjects with type I or II diabetes who undergo percutaneous implantation of the NS100 device with continuous glucose monitoring. Approximately 50 patients will be enrolled.

    The science of peripheral nerve stimulation

    Peripheral electrical nerve stimulation (PENS) has been studied for decades as an approach to managing chronic pain conditions. NeuroDynamics Global builds on this foundation with a protocol specifically designed for painful diabetic neuropathy.

    Neuromodulation works by delivering electrical stimulation to peripheral nerves, which may help modulate pain signaling pathways. The 20-day protocol is designed to provide therapeutic benefit that extends beyond the treatment period.

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    Mechanism of Action

    Targeted nerve stimulation to modulate pain signals

    Patient Selection

    Criteria for identifying appropriate candidates

    Clinical Protocol

    Standardized 20-day therapy protocol

    Interested in research collaboration?

    We partner with leading academic medical centers. Contact us to discuss research opportunities.

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