Peripheral Nerve DisorderEarly Phase 1NCT06772142
Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device
A Early Phase 1 study testing Peripheral Nerve Stimulation in people with Peripheral Nerve Disorder, run by Nervonik at 1 site in Panama.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Nerve Disorder
- What is being tested?
- Peripheral Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePanama
- Study dates
- 27 Nov 2024to 31 Dec 2028
- Phase
- Early Phase 1
- 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 has been diagnosed with knee, arm, or shoulder chronic pain (NRS of at least 5 out of 10).
- 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
- 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 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.
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.
- Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.
- 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.
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- 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 Spanish 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. Recommend 60.
- 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Panama1 site, 1 recruiting
- Recruiting
Hospital Punta Pacifica
Panama City, Provincia de Panamá, 0831-01593
Depatment Chairman, Neurology, 5072048000, dr.ricardo.bermudez@gmail.com
About this study
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.
- Conditions
- Peripheral Nerve Disorder
- Being tested
- Peripheral Nerve Stimulation
- Keywords
- peripheral, nerve, stimulation
- Medical subject headings
- Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Nerve StimulationDevice
Peripheral Nerve Stimulation
| Study group | Role | What they receive |
|---|---|---|
| COHORT 1, Acute | Other | 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. Receives: Device: Peripheral Nerve Stimulation |
| COHORT 2, Chronic | Other | 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. Receives: Device: Peripheral Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint 1
Safety - reporting of adverse events
Measured: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
Primary Endpoint 2
Device performance - successfully delivering current to the nerve
Measured: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
Secondary outcomes (3)
Secondary Outcome 1
Average pain intensity, Long Term durability of Average Pain Intensity (Numeric Rating Scale (NRS)
Measured: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
Secondary Outcome 2
Patient Global Impression of Change (PGIC) - PGIC assesses the patient's impression of change in quality of life.
Measured: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
Secondary Outcome 3
Patient Interview
Measured: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start27 Nov 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve DisorderStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nervonik
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772142
- Sponsor's protocol ID
- CIP 001
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device
- ClinicalTrials.gov ID
- NCT06772142
- Acronym / sponsor ID
- CIP 001
- Conditions
- Peripheral Nerve Disorder
- Keywords
- peripheral, nerve, stimulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- NervonikIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Jan 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COHORT 1, Acute | Other | Device: Peripheral Nerve StimulationThe 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, Chronic | Other | Device: Peripheral Nerve StimulationThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject is between 18 to 80 years of age at the time of enrollment.
- Subject has been diagnosed with knee, arm, or shoulder chronic pain (NRS of at least 5 out of 10).
- 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
- 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.
Key exclusion criteria (21 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.
- Subject has previously failed PNS or Spinal Cord Stimulation (SCS) or Dorsal Root Ganglion (DRG) therapy (trial or permanent implant). See note below.
- 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.
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 |
|---|---|---|
| Peripheral Nerve StimulationPeripheral Nerve Stimulation | Device | COHORT 1, Acute, COHORT 2, Chronic |
Primary outcome
Primary Endpoint 1
Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
Safety - reporting of adverse events
Primary Endpoint 2
Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
Device performance - successfully delivering current to the nerve
3 secondary outcomes
Secondary Outcome 1
Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
Secondary Outcome 2
Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
Secondary Outcome 3
Time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]
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 13 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Peripheral Nerve Stimulation in people with Peripheral Nerve Disorder, run by Nervonik at 1 site in Panama.
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 8 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Depatment Chairman, Neurology (5072048000, dr.ricardo.bermudez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint 1 (time frame: Through study completion, average of 1 day [Cohort 1] and average of 1 year [Cohort 2]). 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 13 Apr 2026.