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

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

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 have nerve or joint pain in my back, shoulder, knee, or foot due to surgery, injury, or arthritis.

My pain level in the target area is at least 6 out of 10.

I am between 18 and 80 years old.

My pain level in the target area is at least 6 out of 10.

Exclusion Criteria

I have tried and not benefited from nerve or spinal cord stimulation therapies.

I do not experience pain when I am resting.

I have a diagnosed nerve pain condition like CRPS or Charcot-Marie-Tooth Disease.

My depression or psychiatric condition is not under control.

I have a bleeding or clotting disorder, or severe vascular disease that hasn't been treated.

I currently have an infection that affects my whole body.

I have cancer that has spread or shows signs of affecting my body in unusual ways.

I have diabetes with uncontrolled blood sugar and nerve damage.

I take 90 mg or more of pain medication equivalent to morphine daily.

Treatment Details

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