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Neurostimulation Device

Nerve Stimulation for Chronic Pain (COMFORT 2 Trial)

N/A

Recruiting

Research Sponsored by Nalu Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 has chronic, intractable peripheral neuropathic pain, exclusive of the craniofacial region; any nociceptive pain must be less prominent than the neuropathic pain.

Must not have

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.

Uncontrolled depression or uncontrolled psychiatric disorders.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6 and 12 months

Awards & highlights

Summary

This trial is studying if nerve stimulation plus medical care is better than medical care alone to treat chronic nerve pain due to trauma or surgery.

Who is the study for?

Adults aged 18-80 with chronic, intractable peripheral neuropathic pain not including the face, who have a pain score of at least 6 and stable pain for 60 days. They must be on consistent pain medication for 30 days and cannot have an active implantable device or certain medical conditions that would interfere with the study.

What is being tested?

The trial is testing the Nalu Neurostimulation System plus conventional medical management against conventional medical management alone to treat chronic peripheral neuralgia from post-traumatic or postsurgical origins. It's a controlled trial where participants are randomly assigned to one of these two groups.

What are the potential side effects?

Potential side effects may include discomfort at the site of stimulation, skin irritation from adhesives or device wearables, and typical risks associated with any surgical procedure if applicable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have long-lasting nerve pain in my body, not including my face, that is worse than any other pain.

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

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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a procedure to treat a nerve or its roots for pain relief.

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I do not have uncontrolled depression or psychiatric disorders.

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I have a diagnosed nerve pain condition like CRPS or neuropathy.

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I have diabetes that is not well-managed and I am experiencing nerve pain.

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I currently have an infection that affects my whole body.

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I do not experience pain when I am resting.

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I have a bleeding or clotting disorder, or a worsening blood vessel disease that hasn't been treated.

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

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

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I've had a procedure in the last 3 months that reduced my pain by at least half.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6 and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3, 6 and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6 and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effectiveness: Responder Rates between the 2 groups

Safety: Rate of serious and non-serious device effects

Secondary study objectives

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

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

Functional Outcomes: Patient Global Impression of Change (PGIC)

+2 more

Trial Design

2Treatment groups

Active Control

Group I: PNS Therapy plus Conventional Medical Management (CMM)Active Control2 Interventions

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

Group II: Conventional Medical ManagementActive Control1 Intervention

Subjects will receive only CMM

0 / 15Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nalu Medical, Inc.Lead Sponsor

2 Previous Clinical Trials

260 Total Patients Enrolled

Patrick MartinStudy DirectorNalu Medical, Inc.

2 Previous Clinical Trials

260 Total Patients Enrolled

Media Library

Nalu Neurostimulation System for PNS (Neurostimulation Device) Clinical Trial Eligibility Overview. Trial Name: NCT05870124 — N/A

Peripheral Neuropathy Research Study Groups: PNS Therapy plus Conventional Medical Management (CMM), Conventional Medical Management

Peripheral Neuropathy Clinical Trial 2023: Nalu Neurostimulation System for PNS Highlights & Side Effects. Trial Name: NCT05870124 — N/A

Nalu Neurostimulation System for PNS (Neurostimulation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05870124 — N/A

~6 spots leftby Oct 2024

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