Your session is about to expire
← Back to Search
Neurostimulation Device
Micro-Implantable Pulse Generator for Chronic Pain (COMFORT 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 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 should have a pain score of at least 6, in the target area of pain, as recorded on the BPI-Q5 (NRS) at screening.
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6 and 12 months
Awards & highlights
Summary
This trial is testing whether adding peripheral nerve stimulation to conventional medical management is more effective and safe than just using conventional medical management for chronic, intractable peripheral neuralgia that is of post-traumatic or post-surgical origin.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects may include discomfort at the implant site, skin irritation from adhesives used in the device components, and potential infection risks associated with any implanted device.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have nerve or joint pain in my back, shoulder, knee, or foot due to surgery, injury, or arthritis.
Select...
My pain level in the target area is at least 6 out of 10.
Select...
I am between 18 and 80 years old.
Select...
My pain level in the target area is at least 6 out of 10.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have tried and not benefited from nerve or spinal cord stimulation therapies.
Select...
I do not experience pain when I am resting.
Select...
I have a diagnosed nerve pain condition like CRPS or Charcot-Marie-Tooth Disease.
Select...
My depression or psychiatric condition is not under control.
Select...
I have a bleeding or clotting disorder, or severe vascular disease that hasn't been treated.
Select...
I currently have an infection that affects my whole body.
Select...
I have cancer that has spread or shows signs of affecting my body in unusual ways.
Select...
I have diabetes with uncontrolled blood sugar and nerve damage.
Select...
I take 90 mg or more of pain medication equivalent to morphine daily.
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
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 groups
Safety: Rate of serious and non-serious adverse events between groups
Secondary study objectives
Functional Outcomes: Change in ODI, BDI, EQ-5D, BPI from baseline
Responder Rates between groups at 12-months
Responder Rates between groups at 6-months
+1 moreTrial Design
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
Find a Location
Who is running the clinical trial?
Nalu Medical, Inc.Lead Sponsor
2 Previous Clinical Trials
210 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
100 Patients Enrolled for Peripheral Neuropathy
Patrick MartinStudy DirectorNalu Medical
2 Previous Clinical Trials
210 Total Patients Enrolled
1 Trials studying Peripheral Neuropathy
100 Patients Enrolled for Peripheral Neuropathy
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not experience pain when I am resting.I can correctly place the adhesive clip or use the relief belt/cuff for the therapy disc.I have a diagnosed nerve pain condition like CRPS or Charcot-Marie-Tooth Disease.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.I've had a specific nerve treatment but not on my spinal cord or the nerve in this study.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 have nerve or joint pain in my back, shoulder, knee, or foot due to surgery, injury, or arthritis.My depression or psychiatric condition is not under control.You are allergic to the materials used in the device or cannot tolerate wearing the device.I have a bleeding or clotting disorder, or severe vascular disease that hasn't been treated.My pain levels have been stable for the last 60 days.I am between 18 and 80 years old.My pain level in the target area is at least 6 out of 10.I currently have an infection that affects my whole body.I have had severe nerve pain in my body, excluding my face, for over 6 months.I take 90 mg or more of pain medication equivalent to morphine daily.I have had severe nerve pain in my body, excluding my face, for over 6 months.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've had a procedure in the last 3 months that reduced my pain by at least half.I have tried and not benefited from nerve or spinal cord stimulation therapies.You are mentally able to receive a peripheral nerve stimulator and don't have psychological conditions that would affect your ability to report your experiences or finish the study tasks.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional Medical Management
- Group 2: PNS Therapy plus Conventional Medical Management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Peripheral Neuropathy Patient Testimony for trial: Trial Name: NCT05287373 — N/A
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger