- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05287373
Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain (COMFORT)
February 13, 2023 updated by: Nalu Medical, Inc.
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85258
- Recruiting
- Arizona Pain Specialists
-
-
Colorado
-
Greenwood Village, Colorado, United States, 80111
- Recruiting
- Denver Back Pain Specialists
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20006
- Recruiting
- International Spine, Pain and Performance Center
-
-
Texas
-
Corpus Christi, Texas, United States, 78414
- Recruiting
- Institute of Precision Pain Medicine
-
-
Washington
-
Spokane, Washington, United States, 99201
- Recruiting
- Northwest Pain Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject is between 18 to 80 years of age at the time of enrollment.
- Subject would have been prescribed PNS therapy regardless of participation in this study; the use of the Nalu device must be on-label.
- 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 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.
- 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 is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.
- Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.
- Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.
- 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.
- 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:
- 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.
- 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.
- 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.
- Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
- 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.
- Uncontrolled depression or uncontrolled psychiatric disorders
- Subject is currently participating in another clinical investigation with an active treatment arm.
- 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.
- 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.
- Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease that has not been medically corrected.
- Subject has an active systemic infection.
- Subject is unable to read and/or write in English or give informed consent.
- Subject has a life expectancy of less than 1 year.
- Subject has an active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome.
- Subject with uncontrolled diabetes mellitus, showing signs of diabetic neuropathy, as evidenced by a neurological exam and a HbA1c test.
- Subject has evidence of an alcohol or drug dependency within the last 6 months prior to enrollment.
- 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).
- Subject is nursing/breastfeeding.
- Subject is on ≥90 mg-morphine equivalents per 24 hours.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: PNS Therapy plus Conventional Medical Management
peripheral nerve stimulator plus conventional medical management
|
The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator
Other Names:
Conventional medical management
|
Other: Conventional Medical Management
Control arm conventional medical management only
|
Conventional medical management
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
3-months
|
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
|
3-months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
6 months
|
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).
|
12-months
|
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
|
3, 6 and 12 months
|
Safety Assessment
Time Frame: 6 and 12 months
|
Rate of serious and non-serious events
|
6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 31, 2022
Primary Completion (Anticipated)
February 28, 2024
Study Completion (Anticipated)
September 30, 2024
Study Registration Dates
First Submitted
February 8, 2022
First Submitted That Met QC Criteria
March 10, 2022
First Posted (Actual)
March 18, 2022
Study Record Updates
Last Update Posted (Actual)
February 15, 2023
Last Update Submitted That Met QC Criteria
February 13, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAL-01-2021-US
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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