Tiny implant zaps away chronic joint pain in early trial
NCT ID NCT06772142
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests a small device that sends gentle electrical pulses to nerves to relieve severe, long-lasting knee, elbow, or shoulder pain. About 30 adults with chronic pain will first try a temporary implant for up to 8 hours. If it works well, they can get a permanent version. The main goals are safety and whether the device successfully delivers stimulation to the nerve.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 informed consent. 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 clinically relevant 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: 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 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. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Punta Pacifica
RECRUITINGPanama City, Provincia de Panamá, 0831-01593, Panama
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