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

• ClinicalTrials.gov Identifier: NCT05287373
• Recruitment Status: Recruiting
• First Posted: March 18, 2022
• Last Update Posted: February 15, 2023
• Sponsor: Nalu Medical, Inc.
• Information provided by (Responsible Party): Nalu Medical, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Peripheral Neuralgia; Chronic Pain	Device: Nalu Neurostimulation System for PNS; Other: conventional medical management	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain
• Actual Study Start Date: January 31, 2022
• Estimated Primary Completion Date: February 28, 2024
• Estimated Study Completion Date: September 30, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PNS Therapy plus Conventional Medical Management; peripheral nerve stimulator plus conventional medical management	Device: Nalu Neurostimulation System for PNS; The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator; Other Name: Nalu PNS; Other: conventional medical management; Conventional medical management
Conventional Medical Management; Control arm conventional medical management only	Other: conventional medical management; Conventional medical management

Outcome Measures

Primary Outcome Measures :

1. Effectiveness: Responder rates between groups [ Time Frame: 3-months ]
   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).
2. Safety: Rate of serious and non-serious adverse events between groups [ Time Frame: 3-months ]
   Rate of serious and non-serious adverse events between groups

Secondary Outcome Measures :

1. Responder Rates between groups at 6-months [ Time Frame: 6 months ]
   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).
2. Responder Rates between groups at 12-months [ Time Frame: 12-months ]
   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. Functional Outcomes: Change in ODI, BDI, EQ-5D, BPI from baseline [ Time Frame: 3, 6 and 12 months ]
   Change in patient reported outcomes from baseline between groups
4. Safety Assessment [ Time Frame: 6 and 12 months ]
   Rate of serious and non-serious events

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease that has not been medically corrected.
12. 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.
16. Subject with uncontrolled diabetes mellitus, showing signs of diabetic neuropathy, as evidenced by a neurological exam and a HbA1c test.
17. Subject has evidence of an alcohol or drug dependency within the last 6 months prior to enrollment.
18. 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).
19. 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.

Contacts and Locations

Contacts

Contact: Shilpa Kottalgi, BDS, MAS; 760 827 6467; skottalgi@nalumed.com

Locations

United States, Arizona

Arizona Pain Specialists; Recruiting

Scottsdale, Arizona, United States, 85258

Contact: Clinical Research Coordinator

United States, Colorado

Denver Back Pain Specialists; Recruiting

Greenwood Village, Colorado, United States, 80111

Contact: Clinical Research Coordinator

United States, District of Columbia

International Spine, Pain and Performance Center; Recruiting

Washington, District of Columbia, United States, 20006

Contact: Clinical research coordinator

United States, Texas

Institute of Precision Pain Medicine; Recruiting

Corpus Christi, Texas, United States, 78414

Contact: Clinical Research Coordinator

United States, Washington

Northwest Pain Care; Recruiting

Spokane, Washington, United States, 99201

Contact: Clinical Research Coordinator

Sponsors and Collaborators

Nalu Medical, Inc.

Investigators

• Study Director: Patrick Martin; Nalu Medical

More Information

• Responsible Party: Nalu Medical, Inc.
• ClinicalTrials.gov Identifier: NCT05287373
• Other Study ID Numbers: NAL-01-2021-US
• First Posted: March 18, 2022
• Last Update Posted: February 15, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nalu Medical, Inc.:

PNS; Peripheral nerve stimulation; mIPG; peripheral nerve stimulator

Additional relevant MeSH terms:

Neuralgia; Chronic Pain; Pain; Neurologic Manifestations; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases