Micro-Implantable Pulse Generator for Chronic Pain
(COMFORT Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Nalu Medical, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

Adults aged 18-80 with chronic, intractable peripheral neuropathic pain for at least 6 months, not including the face. Pain must be mainly neuropathic from conditions like nerve injury or osteoarthritis. Participants need a pain score of at least 6 and stable medication use for 30 days. They can't have other active implants, recent successful pain treatments, uncontrolled mental health issues, allergies to device materials, certain medical conditions or be pregnant.

Inclusion Criteria

I can correctly place the adhesive clip or use the relief belt/cuff for the therapy disc.

I would be prescribed PNS therapy even if I wasn't part of this study, and using the Nalu device is appropriate for my condition.

I have been on a stable pain medication plan for the last 30 days.

+10 more

Exclusion Criteria

I do not experience pain when I am resting.

Subject is currently participating in another clinical investigation with an active treatment arm.

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.

+18 more

Participant Groups

The trial is testing the Nalu Neurostimulation System plus usual medical care against medical care alone for treating long-term peripheral neuralgia after trauma or surgery. It's a prospective study where participants are randomly assigned to either receive the new treatment or stick with standard care.

2Treatment groups

Experimental Treatment

Active Control

Group I: Conventional Medical ManagementExperimental Treatment1 Intervention

Control arm conventional medical management only

Group II: PNS Therapy plus Conventional Medical ManagementActive Control2 Interventions

peripheral nerve stimulator plus conventional medical management