Early Phase 1 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are between 18 and 80 years old at the time of joining.
• People who have been diagnosed with chronic pain in the knee, arm, or shoulder, rated at least 5 out of 10 on a pain scale.
• People whose pain is related to nerve damage or nerve problems, such as pain from a past injury or surgery, scarring from surgery, a trapped nerve, or other nerve pain conditions.
• People who are willing to follow all study requirements, attend all visits, and complete all study procedures.
• People whose pain level has been stable (not getting worse) for at least 60 days before signing the consent form.
• People who are currently on pain medication, and whose medication type and dose have stayed the same for at least 30 days before signing the consent form.
• People who a clinician has determined are psychologically suitable to receive a nerve stimulator device, with no psychological conditions that would affect their ability to report their pain accurately or complete the study.
• People who have shown they are able to correctly position the wearable device on the part of the body where the implant would likely be placed, or who are able to use a support belt or limb cuff to keep the device in place.

Who may not be able to join:

• People who already have an implanted medical device, such as a drug pump, spinal cord stimulator, nerve stimulator, deep brain stimulator, or heart pacemaker.
• People who have previously tried nerve stimulation therapy (peripheral nerve stimulation, spinal cord stimulation, or dorsal root ganglion stimulation) and it did not work for them.
• People whose pain is completely gone when they are at rest.
• People who have been diagnosed with complex regional pain syndrome (CRPS), nerve pain caused by a metabolic condition, shingles-related nerve pain, a genetically or metabolically caused nerve disease (such as Charcot-Marie-Tooth disease), or a nerve condition affecting both movement and sensation.
• People who have a medical condition that the study investigator or medical monitor believes would prevent safe participation.
• People who have had a successful pain treatment (such as a nerve block) within the past 3 months for the same pain condition being studied, where "successful" means it provided 50% or more pain relief.
• People with uncontrolled depression or uncontrolled psychiatric conditions.
• People who are currently taking part in another clinical trial that involves an active treatment.
• People who are allergic or sensitive to the materials in the device, including skin adhesives, or who cannot tolerate wearing the device on their body.
• People who have unresolved legal matters related to their chronic pain, such as an ongoing workers' compensation claim or similar issue.
• People who have a blood clotting disorder, a bleeding condition, or progressive blood vessel disease that has not been medically treated.
• People who have an active infection anywhere in the body.
• People who are unable to read or write in Spanish, or who are unable to give informed consent.
• People who have a life expectancy of less than one year.
• People who have an active cancer (either localised or spread to other parts of the body), or signs of a cancer-related nerve condition.
• People with uncontrolled diabetes who are showing signs of diabetic nerve damage, as confirmed by a neurological examination and a blood sugar test (HbA1c).
• People who have shown signs of alcohol or drug dependency within the 6 months before joining the trial.
• People who are pregnant. (Females who are sexually active must be using reliable contraception, have had a surgical procedure to prevent pregnancy, or be at least one year past menopause.)
• People who are currently breastfeeding.
• People who are taking high doses of opioid pain medication — specifically 90 mg or more of morphine equivalent per day.
• People who have had a procedure that permanently destroyed the target nerve or related nerve pathways being treated in the study (confirm with trial site for specific details about which procedures may or may not apply).

Important: Always verify eligibility with the trial site directly before applying.