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Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGNA

Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain

NCT05287373•Nalu Medical, Inc.

View on ClinicalTrials.gov

Summary

This post market study is being conducted to document the comparative effectiveness and safety of peripheral nerve stimulation plus conventional medical management versus conventional medical management alone in the treatment of chronic, intractable peripheral neuralgia of post-traumatic or post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is between 18 to 80 years of age at the time of enrollment.
•2. Subject would have been prescribed PNS therapy regardless of participation in this study; the use of the Nalu device must be on-label.
•3. Subject has been diagnosed with one or more of the conditions listed below in the low back, shoulder, knee, or foot (including ankle):Post-surgical/post-traumatic peripheral neuralgia including but not limited to pain due to peripheral nerve injury, post-surgical scar formation, nerve entrapment; Mononeuropathy, specified or unspecified or in diseases classified elsewhere; Other neuralgia or neuropathic pain; Osteoarthritic pain.
•4. Subject has chronic (defined as at least 6 months duration), intractable peripheral neuropathic pain, exclusive of the craniofacial region; any nociceptive pain must be less prominent than the neuropathic pain. Pain should have a predominant neuropathic component as per the investigator's clinical assessment.
•5. Subject should have a pain score of at least 6, in the target area of pain, as recorded on the BPI-Q5 (NRS) at screening.
•6. Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.
•7. Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.
•8. Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.
•9. Subject is psychologically qualified to receive a peripheral nerve stimulator as per the clinician's standard clinical practice and judgment and does not have clinically relevant psychological condition(s) that would interfere with their ability to accurately report outcomes or complete study procedures.
•10. Subject has demonstrated the ability to appropriately place the adhesive clip in the location where the IPG is most likely to be implanted. Alternatively, subject is able to appropriately use the relief belt and/or limb cuff to keep the Therapy Disc in place.

Exclusion Criteria

•1. Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker.
•2. Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant)
•3. Pain is completely absent at rest.
•4. Patient has clinical evidence of complex regional pain syndrome (CRPS), peripheral neuralgia of metabolic origin, post-herpetic neuralgia, biochemical evidence of a metabolic or genetic neuropathy (e.g., Charcot'- Marie- Tooth Disease) or mixed motor/sensory polyneuropathy.
•5. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
•6. Subject has had a successful (≥ 50% pain relief) interventional procedure within the past 3 months to treat the same pain condition(s) being examined in this study including, nerve blocks.
•7. Uncontrolled depression or uncontrolled psychiatric disorders
•8. Subject is currently participating in another clinical investigation with an active treatment arm.
•9. Subject is allergic or sensitive to materials used in the device components including, skin adhesives or does not tolerate the wearable aspect of the device.
•10. Subject has pending or ongoing legal issues (including unresolved worker's compensation claims or equivalent) or other conflicting secondary gain issues related to their chronic pain condition.
+11 more criteria

Locations (11)

Arizona Pain Specialists

Scottsdale, Arizona, United States

Comprehensive Spine & Pain Physicians

Burbank, California, United States

Pain Management and Injury Relief

Thousand Oaks, California, United States

DBPS Research LLC

Denver, Colorado, United States

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, United States

The Center for Clinical Research

Winston-Salem, North Carolina, United States

Pacific Sports and Spine

Eugene, Oregon, United States

Columbia Pain Management

Milwaukie, Oregon, United States

Pain Specialists of America

Austin, Texas, United States

Institute of Precision Pain Medicine

Corpus Christi, Texas, United States

Key Dates

Start Date

February 23, 2022

Primary Completion Date

December 11, 2023

Completion Date

September 30, 2026

Last Updated

March 4, 2026

Enrollment

ACTUAL participants

Conditions

Peripheral NeuralgiaChronic Pain

Interventions

Nalu Neurostimulation System for PNS

DEVICE

conventional medical management

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain

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