Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)

NCT05870124 | Active Not Recruiting FDA Device

• 1 other identifier: NAL-01-2023-US
• Study Type: interventional
• Target: 185
• Locations: 1 country
• Sites: 17

Brief 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 postsurgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

Conditions

Peripheral Neuropathy; Chronic Pain; Peripheral Neuralgia

Keywords

PNS; Peripheral nerve stimulation; micro-IPG; peripheral nerve stimulator; chronic pain

Outcome Measures

Primary Outcomes (2)

• Effectiveness: Responder Rates between the 2 groups

  Difference in responder rates between groups. Responder rate is defined as the percent of subjects with 50% or greater pain relief from baseline, based on the Numeric Rating Scale (0-10; 0=no pain, 10=worst pain imaginable)

  3-months

• Safety: Rate of serious and non-serious device effects

  Rate of serious and non-serious adverse device events between groups

  3-months

Secondary Outcomes (5)

• Responder Rates

  6-months,12 months, 24 months and 36-months

• Functional Outcomes: Change in Oswestry Disability Index (ODI) score from baseline to protocol defined timepoints

  3 months, 6-months,12 months, 24 months and 36-months

• Functional Outcomes: Change in Beck's Depression Inventory (BDI) score from baseline

  3 months, 6-months,12 months, 24 months and 36-months

• Functional Outcomes: Patient Global Impression of Change (PGIC)

  3 months, 6-months,12 months, 24 months and 36-months

• Safety Assessment

  6-months,12 months, 24 months and 36-months

Study Arms (2)

PNS Therapy plus Conventional Medical Management (CMM)

ACTIVE COMPARATOR

Subjects in this arm will receive a peripheral nerve stimulator and conventional medical management

Device: Nalu Neurostimulation System for PNS; Other: Conventional Medical Management

Conventional Medical Management

ACTIVE COMPARATOR

Subjects will receive only CMM

Other: Conventional Medical Management

Interventions

Nalu Neurostimulation System for PNS DEVICE

The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator

Also known as: Nalu PNS

PNS Therapy plus Conventional Medical Management (CMM)

Conventional Medical Management OTHER

Conventional Medical Management is the best standard of care treatment for the patient

Conventional Medical Management; PNS Therapy plus Conventional Medical Management (CMM)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 18 to 80 years of age at the time of enrollment.
• Subject would have been prescribed PNS therapy regardless of participation in this study; the use of the Nalu device must be on-label.
• 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
• 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.
• 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.
• Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.
• Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.
• Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.
• 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.
• 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.

You may not qualify if:

• 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.
• \. Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.
• \. 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.
• \. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
• \. 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.
• \. Uncontrolled depression or uncontrolled psychiatric disorders 8. Subject is currently participating in another clinical investigation with an active treatment arm.
• \. 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.
• \. 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.
• \. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease that has not been medically corrected.
• \. Subject has an active systemic infection. 13. Subject is unable to read and/or write in English or give informed consent. 14. Subject has a life expectancy of less than 1 year. 15. Subject has an active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome.
• \. Subject with uncontrolled diabetes mellitus, showing signs of diabetic neuropathy, as evidenced by a neurological exam and a HbA1c test.
• \. Subject has evidence of an alcohol or drug dependency within the last 6 months prior to enrollment.
• \. Subject is pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 1 year post-menopausal).
• \. Subject is nursing/breastfeeding. 20. Subject is on ≥90 mg-morphine equivalents per 24 hours. 21. Subject has undergone an ablative treatment of the target peripheral nerve, or proximal nerve trunk giving rise to the target nerve, or dorsal roots (and DRGs) that ultimately make up the target nerve. No ablative procedures directed at the spinal cord, dorsal roots, or peripheral nerve(s) being treated in the study. To note, subjects who have undergone RF ablation of the dorsal rami, cool pulsed RF of the facet innervation may be considered for enrollment.

Sponsors & Collaborators

• Nalu Medical, Inc.: lead

Study Sites (17)

The Pain Institute of Southern Arizona

Tucson, Arizona, 85710, United States

Location

Comprehensive Spine & Pain Physicians

Burbank, California, 91505, United States

Location

Pain Management and Injury Relief

Thousand Oaks, California, 91320, United States

Location

DBPS Research LLC

Denver, Colorado, 80111, United States

Location

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, 20037, United States

Location

Coastal Spine & Pain Center

Jacksonville, Florida, 23305, United States

Location

University of Kansas Health System, Bell Hospital Marc A. Asher Comprehensive Spine Center

Kansas City, Kansas, 66160, United States

Location

Insight Research Institute

Flint, Michigan, 48507, United States

Location

NeuroInterventional Pain Management

Monroe, Michigan, 48161, United States

Location

Michigan Neurology & Spine Center

Port Huron, Michigan, 48060, United States

Location

Advanced Orthopedics and Sports Medicine Institute

Freehold, New Jersey, 07728, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Pacific Sports and Spine

Eugene, Oregon, 97401, United States

Location

Columbia Pain Management

Milwaukie, Oregon, 97222, United States

Location

Pain Specialists of America

Austin, Texas, 78745, United States

Location

Institute of Precision Pain Medicine

Corpus Christi, Texas, 78414, United States

Location

Anesis Spine and Pain Care

Spokane, Washington, 99216, United States

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Chronic Pain

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Martin

  Nalu Medical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 23, 2023
• Study Start: April 27, 2023
• Primary Completion: April 15, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 4, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)