Peripheral NeuralgiaCOMFORT 2NCT05870124
Clinical Study of a Micro-Implantable Pulse Generator for the Treatment of Peripheral Neuropathic Pain (COMFORT 2)
A study testing Nalu Neurostimulation System for PNS and Conventional Medical Management in people with Peripheral Neuralgia and Peripheral Neuropathy, run by Nalu Medical, Inc. at 17 sites in United States.
Trial summary
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 postsurgical origin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Neuralgia, Peripheral Neuropathy, Chronic Pain
- What is being tested?
- Nalu Neurostimulation System for PNS and Conventional Medical Management
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 17 sitesUnited States
- Study dates
- 27 Apr 2023to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
- 2. Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.
- 3. Pain is completely absent at rest. 4. 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.
- 5. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
- 6. 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.
- 7. Uncontrolled depression or uncontrolled psychiatric disorders 8. Subject is currently participating in another clinical investigation with an active treatment arm.
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- 9. 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.
- 10. 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.
- 11. Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, or progressive peripheral vascular disease that has not been medically corrected.
- 12. Subject has an active systemic infection. 13. Subject is unable to read and/or write in English or give informed consent. 14. Subject has a life expectancy of less than 1 year. 15. Subject has an active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome.
- 16. Subject with uncontrolled diabetes mellitus, showing signs of diabetic neuropathy, as evidenced by a neurological exam and a HbA1c test.
- 17. Subject has evidence of an alcohol or drug dependency within the last 6 months prior to enrollment.
- 18. 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).
- 19. Subject is nursing/breastfeeding. 20. Subject is on ≥90 mg-morphine equivalents per 24 hours. 21. 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Pain Specialists of America
Austin, Texas, 78745
Comprehensive Spine & Pain Physicians
Burbank, California, 91505
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414
DBPS Research LLC
Denver, Colorado, 80111
Pacific Sports and Spine
Eugene, Oregon, 97401
Insight Research Institute
Flint, Michigan, 48507
Advanced Orthopedics and Sports Medicine Institute
Freehold, New Jersey, 07728
Coastal Spine & Pain Center
Jacksonville, Florida, 23305
University of Kansas Health System, Bell Hospital Marc A. Asher Comprehensive Spine Center
Kansas City, Kansas, 66160
Columbia Pain Management
Milwaukie, Oregon, 97222
NeuroInterventional Pain Management
Monroe, Michigan, 48161
Michigan Neurology & Spine Center
Port Huron, Michigan, 48060
Anesis Spine and Pain Care
Spokane, Washington, 99216
Pain Management and Injury Relief
Thousand Oaks, California, 91320
The Pain Institute of Southern Arizona
Tucson, Arizona, 85710
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, 20037
The Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain (COMFORT 2)
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 postsurgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.
Read the detailed description
Multi-center, prospective, open-label, randomized controlled trial (RCT) comparing PNS plus CMM with CMM alone. Subjects will be randomized to receive:
Arm 1: Nalu Neurostimulation System for PNS plus CMM Arm 2: CMM alone Consented subjects will receive a baseline evaluation and then be randomized 2:1 into one of two arms: 1) PNS+CMM arm or 2) CMM arm. Subjects assigned to Arm 1 will undergo a trial implant period using best clinical practices. Those subjects who pass the trial implant will receive the permanent implant. At the 3-month end point, subjects in Arm 2 will be given the option to crossover into Arm 1 beginning with a trial implant. All Arm 1 patients receiving a permanent implant will be followed for a total of 36 months after permanent implantation.Arm 2 patients who do not crossover will be followed for a total of 36 months from randomization.
- Conditions
- Peripheral Neuralgia, Peripheral Neuropathy, Chronic Pain
- Being tested
- Nalu Neurostimulation System for PNS, Conventional Medical Management
- Keywords
- PNS, Peripheral nerve stimulation, micro-IPG, peripheral nerve stimulator, chronic pain
- Medical subject headings
- Peripheral Nervous System Diseases, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalu Neurostimulation System for PNSDevice
Also called Nalu PNS
The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator
Conventional Medical ManagementOther
Conventional Medical Management is the best standard of care treatment for the patient
| Study group | Role | What they receive |
|---|---|---|
| PNS Therapy plus Conventional Medical Management (CMM) | Active comparator | Subjects in this arm will receive a peripheral nerve stimulator and conventional medical management Receives: Device: Nalu Neurostimulation System for PNS; Other: Conventional Medical Management |
| Conventional Medical Management | Active comparator | Subjects will receive only CMM Receives: Other: Conventional Medical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Responder Rates between the 2 groups
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 Numeric Rating Scale (0-10; 0=no pain, 10=worst pain imaginable)
Measured: 3-months
Safety: Rate of serious and non-serious device effects
Rate of serious and non-serious adverse device events between groups
Measured: 3-months
Secondary outcomes (5)
Responder Rates
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,0-10 where, 0= no pain; 10=worst pain imaginable).
Measured: 6-months,12 months, 24 months and 36-months
Functional Outcomes: Change in Oswestry Disability Index (ODI) score from baseline to protocol defined timepoints
Change in patient reported ODI from baseline with comparisons between groups. The ODI is scored from 0-100% disability. A lower score, compared to baseline, indicates improvement in ODI.
Measured: 3 months, 6-months,12 months, 24 months and 36-months
Functional Outcomes: Change in Beck's Depression Inventory (BDI) score from baseline
Change in patient reported depression from baseline with comparison between groups. The BDI is scored from 0-63. A lower score at follow-up, compared to baseline, indicates an improvement in depression symptoms and mood.
Measured: 3 months, 6-months,12 months, 24 months and 36-months
Functional Outcomes: Patient Global Impression of Change (PGIC)
PGIC is reported by the patient post-implant, on a 7-point likert scale to indicate overall changes in mood, activity, emotional well-being and quality of life. Proportion of patients showing improvement, worsening or no change, will be collected and reported at protocol specified time points.
Measured: 3 months, 6-months,12 months, 24 months and 36-months
Safety Assessment
Rate of serious and non-serious device effects
Measured: 6-months,12 months, 24 months and 36-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start27 Apr 2023
- Primary completion15 Apr 2025
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuralgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nalu Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Martin, Study director, Nalu Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870124
- Sponsor's protocol ID
- NAL-01-2023-US
- Acronym
- COMFORT 2
- Status last verified
- Jul 2025
- First submitted
- 1 May 2023
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain (COMFORT 2)
- ClinicalTrials.gov ID
- NCT05870124
- Acronym / sponsor ID
- COMFORT 2 / NAL-01-2023-US
- Conditions
- Peripheral Neuralgia, Peripheral Neuropathy, Chronic Pain
- Keywords
- PNS, Peripheral nerve stimulation, micro-IPG, peripheral nerve stimulator, chronic pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Nalu Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 postsurgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.
Detailed description
Multi-center, prospective, open-label, randomized controlled trial (RCT) comparing PNS plus CMM with CMM alone. Subjects will be randomized to receive:
Arm 1: Nalu Neurostimulation System for PNS plus CMM Arm 2: CMM alone Consented subjects will receive a baseline evaluation and then be randomized 2:1 into one of two arms: 1) PNS+CMM arm or 2) CMM arm. Subjects assigned to Arm 1 will undergo a trial implant period using best clinical practices. Those subjects who pass the trial implant will receive the permanent implant. At the 3-month end point, subjects in Arm 2 will be given the option to crossover into Arm 1 beginning with a trial implant. All Arm 1 patients receiving a permanent implant will be followed for a total of 36 months after permanent implantation.Arm 2 patients who do not crossover will be followed for a total of 36 months from randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNS Therapy plus Conventional Medical Management (CMM) | Active comparator | Device: Nalu Neurostimulation System for PNS, Other: Conventional Medical ManagementSubjects in this arm will receive a peripheral nerve stimulator and conventional medical management |
| Conventional Medical Management | Active comparator | Other: Conventional Medical ManagementSubjects will receive only CMM |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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):
- 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.
Key exclusion criteria (14 listed)
- 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.
- 2. Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.
- 3. Pain is completely absent at rest. 4. 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.
- 5. Subject has a medical condition that would prevent them from participating in the current study per investigator's or medical monitor's judgment.
- 6. 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalu Neurostimulation System for PNSAlso: Nalu PNSThe Nalu Neurostimulation System for PNS is a peripheral nerve stimulator | Device | PNS Therapy plus Conventional Medical Management (CMM) |
| Conventional Medical ManagementConventional Medical Management is the best standard of care treatment for the patient | Other | Conventional Medical Management, PNS Therapy plus Conventional Medical Management (CMM) |
Primary outcome
Effectiveness: Responder Rates between the 2 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 Numeric Rating Scale (0-10; 0=no pain, 10=worst pain imaginable)
Safety: Rate of serious and non-serious device effects
Time frame: 3-months
Rate of serious and non-serious adverse device events between groups
5 secondary outcomes
Responder Rates
Time frame: 6-months,12 months, 24 months and 36-months
Functional Outcomes: Change in Oswestry Disability Index (ODI) score from baseline to protocol defined timepoints
Time frame: 3 months, 6-months,12 months, 24 months and 36-months
Functional Outcomes: Change in Beck's Depression Inventory (BDI) score from baseline
Time frame: 3 months, 6-months,12 months, 24 months and 36-months
Functional Outcomes: Patient Global Impression of Change (PGIC)
Time frame: 3 months, 6-months,12 months, 24 months and 36-months
Safety Assessment
Time frame: 6-months,12 months, 24 months and 36-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Martin study director
Nalu Medical, Inc.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nalu Neurostimulation System for PNS and Conventional Medical Management in people with Peripheral Neuralgia and Peripheral Neuropathy, run by Nalu Medical, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Responder Rates between the 2 groups (time frame: 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.