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RecruitingNCT06772142Updated Apr 13, 2026

Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device

An Early Phase 1 interventional study of Peripheral Nerve Stimulation in Peripheral Nerve Disorder, sponsored by Nervonik. Recruiting at 1 site in Panama. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-13.

Sponsored by Nervonik · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

A multicenter, 30 patient prospective single arm evaluation of the Nervonik system in symptomatic patients with chronic severe knee, elbow or shoulder pain.

COHORT 1: The initial cohort of patients will receive the Nervonik neurostimulator for up to 8 hours. The patient will remain local to the care facility for implant stimulator program changes until the patient is satisfied with the degree of pain relief. The implant will be removed from the patient at the end of the evaluation.

COHORT 2: The second cohort of patients will include those patients from cohort 1 who have determined the Nervonik implant provides suitable pain relief and agree to have a permanent implant placed. In addition, the second cohort includes non-cohort one patients meeting the trial requirements and agreeing to participate in the trial.

02

Conditions studied

  • Peripheral Nerve Disorder

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Keywords

  • peripheral
  • nerve
  • stimulation
03

In context

Neuritis

73 studies on the registry are indexed under Neuritis; 20 are open to participants now.

This study's planned enrollment of 30 is below the median of 48 across 51 interventional studies indexed under Neuritis.

Browse Neuritis studies →

Lead sponsor

This is the only study on the registry with Nervonik as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject is between 18 to 80 years of age at the time of enrollment.
  2. Subject has been diagnosed with knee, arm, or shoulder chronic pain (NRS of at least 5 out of 10).
  3. 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
  4. Subject is willing to cooperate with the study requirements including, compliance with the study procedures and completion of all study visits.
  5. Subject reported stable pain (non-escalating) for 60 days prior to signing .
  6. Subject is currently receiving CMM and has had stable pain medication use and dosage for 30 days prior to signing informed consent.
  7. Subject is psychologically qualified to receive a peripheral nerve stimulator as per the clinician's standard clinical practice and judgment and does not have psychological condition(s) that would interfere with their ability to accurately report outcomes or complete study procedures.
  8. Subject has demonstrated the ability to appropriately place the wearable 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 wearable in place.

Exclusion criteria

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). 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.
  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 Spanish or give .
  14. Subject has a of less than 1 year
  15. Subject has an active malignant neoplasm ( 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 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 , be surgically sterile or be at least 1 year ).
  19. Subject is nursing/breastfeeding.
  20. Subject is on ≥90 mg-morphine equivalents per 24 hours. Recommend 60.
  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
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    COHORT 1, Acute

    The initial cohort of patients will receive the Nervonik neurostimulator for up to 8 hours. The patient will remain local to the care facility for implant stimulator program changes until the patient is satisfied with the degree of pain relief. The implant will be removed from the patient at the end of the evaluation.

    Device: Peripheral Nerve Stimulation

  • Other
    COHORT 2, Chronic

    The second cohort of patients will include those patients from cohort 1 who have determined the Nervonik implant provides suitable pain relief and agree to have a permanent implant placed. In addition, the second cohort includes non-cohort one patients meeting the trial requirements and agreeing to participate in the trial.

    Device: Peripheral Nerve Stimulation

Interventions

  • DevicePeripheral Nerve Stimulation

    Peripheral Nerve Stimulation

06

What researchers measure

Primary outcomes

  1. Primary Endpoint 1

    Safety - reporting of adverse events

    Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]

  2. Primary Endpoint 2

    Device performance - successfully delivering current to the nerve

    Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]

Secondary outcomes

  1. Secondary Outcome 1

    Average pain intensity, Long Term durability of Average Pain Intensity (Numeric Rating Scale (NRS)

    Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]

  2. Secondary Outcome 2

    Patient Global Impression of Change (PGIC) - PGIC assesses the patient's impression of change in quality of life.

    Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]

  3. Secondary Outcome 3

    Patient Interview

    Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06772142
Lead sponsor
Nervonik
Responsible party
Sponsor
First posted
Jan 13, 2025
Start date
Nov 27, 2024
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 13, 2026

Study contacts

Depatment Chairman, Neurology
Contact
dr.ricardo.bermudez@gmail.com
5072048000

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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