This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain (COMFORT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05287373
Recruitment Status : Recruiting
First Posted : March 18, 2022
Last Update Posted : February 15, 2023
Sponsor:
Information provided by (Responsible Party):
Nalu Medical, Inc.

Brief 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 post-surgical origin. This is a prospective, minimal risk, multi-center, randomized control trial.

Condition or disease Intervention/treatment Phase
Peripheral Neuralgia Chronic Pain Device: Nalu Neurostimulation System for PNS Other: conventional medical management Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study Of a Micro-Implantable Pulse Generator For The Treatment of Peripheral Neuropathic Pain
Actual Study Start Date : January 31, 2022
Estimated Primary Completion Date : February 28, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PNS Therapy plus Conventional Medical Management
peripheral nerve stimulator plus conventional medical management
Device: Nalu Neurostimulation System for PNS
The Nalu Neurostimulation System for PNS is a peripheral nerve stimulator
Other Name: Nalu PNS

Other: conventional medical management
Conventional medical management

Conventional Medical Management
Control arm conventional medical management only
Other: conventional medical management
Conventional medical management




Primary Outcome Measures :
  1. 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).

  2. 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


Secondary Outcome Measures :
  1. 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).

  2. 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).

  3. 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

  4. Safety Assessment [ Time Frame: 6 and 12 months ]
    Rate of serious and non-serious events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject is between 18 to 80 years of age at the time of enrollment.
  2. Subject would have been prescribed PNS therapy regardless of participation in this study; the use of the Nalu device must be on-label.
  3. 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.
  4. 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.
  5. 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.
  6. Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.
  7. Subject reported stable pain (non-escalating) for 60 days prior to signing informed consent.
  8. Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.
  9. 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.
  10. 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:

  1. 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)
  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.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05287373


Contacts
Layout table for location contacts
Contact: Shilpa Kottalgi, BDS, MAS 760 827 6467 skottalgi@nalumed.com

Locations
Layout table for location information
United States, Arizona
Arizona Pain Specialists Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Clinical Research Coordinator         
United States, Colorado
Denver Back Pain Specialists Recruiting
Greenwood Village, Colorado, United States, 80111
Contact: Clinical Research Coordinator         
United States, District of Columbia
International Spine, Pain and Performance Center Recruiting
Washington, District of Columbia, United States, 20006
Contact: Clinical research coordinator         
United States, Texas
Institute of Precision Pain Medicine Recruiting
Corpus Christi, Texas, United States, 78414
Contact: Clinical Research Coordinator         
United States, Washington
Northwest Pain Care Recruiting
Spokane, Washington, United States, 99201
Contact: Clinical Research Coordinator         
Sponsors and Collaborators
Nalu Medical, Inc.
Investigators
Layout table for investigator information
Study Director: Patrick Martin Nalu Medical
Layout table for additonal information
Responsible Party: Nalu Medical, Inc.
ClinicalTrials.gov Identifier: NCT05287373    
Other Study ID Numbers: NAL-01-2021-US
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: February 15, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Nalu Medical, Inc.:
PNS
Peripheral nerve stimulation
mIPG
peripheral nerve stimulator
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuralgia
Chronic Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases