Actively Recruiting
Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device
Led by Nervonik · Updated on 2026-04-13
30
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Early Feasibility of the Nervonik Peripheral Nerve Stimulation Device
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 with a numeric rating scale (NRS) of at least 5 out of 10.
- Subject has post-surgical or post-traumatic peripheral neuralgia including pain due to peripheral nerve injury, scar formation, nerve entrapment, mononeuropathy, other neuralgia, or neuropathic pain.
- Subject is willing to comply with study procedures and complete all study visits.
- Subject has had stable, non-escalating pain for 60 days before signing informed consent.
- Subject has been on stable pain medication use and dosage for 30 days before signing informed consent.
- Subject is psychologically qualified to receive the peripheral nerve stimulator and can accurately report outcomes and complete study procedures.
- Subject can properly place the wearable device or use the relief belt or limb cuff to keep the wearable in place.
You will not qualify if you...
- Subject has an active implantable medical device such as a drug pump, spinal cord stimulator, peripheral nerve stimulator, sacral nerve stimulator, deep brain stimulator, or cardiac pacemaker.
- Subject has previously failed peripheral nerve stimulation, spinal cord stimulation, or dorsal root ganglion therapy.
- Subject has no pain at rest.
- Subject has complex regional pain syndrome, metabolic peripheral neuralgia, post-herpetic neuralgia, metabolic or genetic neuropathy, or mixed motor/sensory polyneuropathy.
- Subject has any medical condition preventing study participation as judged by investigators.
- Subject had a successful interventional procedure with at least 50% pain relief for the same pain in the past 3 months.
- Subject has uncontrolled depression or psychiatric disorders.
- Subject is participating in another clinical trial with an active treatment arm.
- Subject is allergic or sensitive to device materials or cannot tolerate the wearable device.
- Subject has unresolved legal issues related to their pain condition.
- Subject has coagulation disorders, bleeding problems, or progressive peripheral vascular disease not corrected medically.
- Subject has an active systemic infection.
- Subject cannot read or write in Spanish or give informed consent.
- Subject has life expectancy less than 1 year.
- Subject has active malignant cancer or paraneoplastic syndrome.
- Subject has uncontrolled diabetes with signs of diabetic neuropathy.
- Subject has alcohol or drug dependency within the last 6 months.
- Subject is pregnant without reliable birth control, nursing, or breastfeeding.
- Subject uses morphine equivalent doses of 90 mg or more per 24 hours.
- Subject underwent ablative treatment of the target peripheral nerve or related nerves, except certain allowed procedures.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Punta Pacifica
Panama City, Provincia de Panamá, Panama, 0831-01593
Actively Recruiting
Research Team
D
Depatment Chairman, Neurology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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