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:

• Adults between 18 and 80 years old (men and women)
• People who are willing and able to give consent and attend all required study visits
• People whose pain has lasted at least 6 months, is rated 5 or higher out of 10 on average, has been at a similar level for at least the past two months, and has made it impossible to work or carry out everyday tasks at home
• People whose pain has not improved enough despite trying at least 3 prescription medications at proper doses, including at least one opioid (either current or past)
• People whose pain has not improved with other treatments such as injections, spinal stimulation, medication infusions, or nerve surgery
• People whose pain is neuropathic (nerve-related), or mostly nerve-related if there are mixed types, and where the pain resulted from a specific injury such as trauma, reduced blood flow, bleeding, infection, a tumour, or a complication of a medical procedure affecting the nerves or brain or spinal cord
• People whose pain condition falls into one of these specific categories: post-stroke pain, thalamic pain, spinal cord injury, brachial plexus injury or limb avulsion, peripheral nerve injury or painful neuropathy, postherpetic neuralgia, Tolosa Hunt syndrome, cavernous sinus syndromes, or trigeminal neuropathic pain (not trigeminal neuralgia)
• People whose brain MRI clearly shows the insula region, so that electrodes can be accurately placed during the procedure
• People who are able to communicate and describe sensations during stimulation testing
• People whose prescription pain medication doses have remained stable for at least 30 days before joining and can remain stable throughout the study
• People whose eligibility has been reviewed and agreed upon by both the principal investigator and a pain psychologist, each of whom has interviewed and examined the person

Who may not be able to join:

• People whose pain falls into certain categories where no specific injury cause has been identified, including fibromyalgia, temporomandibular joint disorders, irritable bowel syndrome, chronic headaches, interstitial cystitis, chronic pelvic pain, or whiplash-associated disorders
• People considered unsuitable by the multidisciplinary team of pain specialists, including neurosurgeons, pain management doctors, and pain psychologists
• People where clinicians have significant concerns about the reliability of the information they report, such as those currently seeking disability status for nerve pain
• People showing behaviours consistent with alcohol or substance misuse within the past 12 months, as defined by recognised diagnostic criteria (confirm with trial site)
• People with suspected dementia or a score below 25 on a standard memory and thinking test
• People with active or significant psychiatric conditions, including schizophrenia, bipolar disorder, current thoughts of suicide, or a suicide attempt within the past two years
• People who have been hospitalised for a psychiatric condition within the past two years
• People who have received transcranial magnetic stimulation or electroconvulsive therapy for depression
• People with any history or current presence of psychosis
• People with unstable heart conditions, including unstable chest pain, a heart attack within the past six months, significant heart failure, or uncontrolled heart rhythm problems
• People with severely high blood pressure (diastolic reading above 100) even while on blood pressure medication
• People who cannot have an MRI scan, for example due to certain metal implants such as a pacemaker, or due to body size limitations
• People currently taking blood-thinning or anti-clotting medications, including certain antiplatelet drugs within the past 7 days, oral or injected anticoagulants within specified timeframes, or heparin-based medications within the past 48 hours (confirm specific timeframes with trial site)
• People who are unable or unwilling to stay in hospital for an extended period with continuous video brain-wave monitoring
• People who have taken part in another clinical trial for chronic pain within the past 30 days
• People with bleeding or clotting disorders, or abnormal results on blood clotting tests
• People with a brain tumour or any significant mass inside the skull
• People with a history of seizures
• People with any other illness that, in the investigator's opinion, would prevent safe participation
• People who are pregnant or breastfeeding
• People with a true allergy to opioid medications, which would prevent a specific type of brain scan (PET imaging) used in the study
• People who do not have the legal capacity to consent to participation
• People who already have a deep brain stimulation device implanted
• People who have had a bleeding stroke or similar blood vessel event in the brain within the past year that has not fully resolved

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