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

NCT05287373 | Active Not Recruiting FDA Device

• 1 other identifier: NAL-01-2021-US
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 13

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 post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

Conditions

Chronic Pain; Peripheral Neuralgia

Keywords

PNS; Peripheral nerve stimulation; mIPG; peripheral nerve stimulator

Outcome Measures

Primary Outcomes (2)

• Effectiveness: Responder rates between 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 BPI-Q5 (NRS).

  3-months

• Safety: Rate of serious and non-serious adverse events between groups

  Rate of serious and non-serious adverse events between groups

  3-months

Secondary Outcomes (6)

• Responder Rates between groups at 6-months

  6 months

• Responder Rates between groups at 12-months

  12-months

• Responder Rates between groups at 24-months

  24-months

• Responder Rates between groups at 36-months

  36-months

• Functional Outcomes: Change in ODI, BDI, EQ-5D, BPI from baseline

  3, 6, 9, 12, 18, 24, 30 and 36 months

Study Arms (2)

PNS Therapy plus Conventional Medical Management

ACTIVE COMPARATOR

peripheral nerve stimulator plus conventional medical management

Device: Nalu Neurostimulation System for PNS; Other: conventional medical management

Conventional Medical Management

OTHER

Control arm conventional medical management only

Other: conventional medical management

Interventions

conventional medical management OTHER

Conventional medical management

Conventional Medical Management; PNS Therapy plus Conventional Medical Management

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

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)
• Pain is completely absent at rest.
• 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
• 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.
• Subject is unable to read and/or write in English or give informed consent.
• Subject has a life expectancy of less than 1 year.
• Subject has an active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome.

Sponsors & Collaborators

• Nalu Medical, Inc.: lead

Study Sites (13)

Arizona Pain Specialists

Scottsdale, Arizona, 85258, United States

Location

University of Arkansas Interventional Spine and Pain Clinic

Little Rock, Arkansas, 72205, United States

Location

Comprehensive Spine & Pain Physicians

Burbank, California, 91505, United States

Location

Stanford University Pain Management Center

Redwood City, California, 94063, 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, 20006, 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

Related Publications (1)

• Hatheway J, Hersel A, Engle M, Gutierrez G, Khemlani V, Kapural L, Moore G, Ajakwe R, Trainor D, Hah J, Staats PS, Makous J, Heit G, Kottalgi S, Desai MJ; COMFORT Study Group. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial. Reg Anesth Pain Med. 2026 Mar 5;51(3):278-284. doi: 10.1136/rapm-2024-106099.

  PMID: 39572166 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrick Martin

  Nalu Medical

  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: February 8, 2022
• First Posted: March 18, 2022
• Study Start: February 23, 2022
• Primary Completion: December 11, 2023
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)