Neuralgia

Researchers are evaluating the effects of a single infusion of (2R,6R)-hydroxynorketamine (HNK) compared to ketamine and saline in adults with chronic neuropathic pain of the extremities lasting more than 3 months. This randomized, double-blind, three-way crossover trial aims to study the pain relief effectiveness and duration of these treatments, as well as their impact on pain qualities, physical function, pain interference, sleep disturbance, and quality of life. Participants will receive three different treatments—ketamine 0.5mg/kg, (2R,6R)-HNK 0.5mg/kg, and saline—each as a 45-minute infusion given in random order with a 5-week interval between infusions over a 15-week period. Five subjects will be assigned to each possible treatment sequence. The study includes a pretreatment evaluation and follow-up assessments at 7, 14, 21, and 35 days after each infusion. During the study, participants will undergo detailed sensory and pain evaluations and complete questionnaires to report their pain and related symptoms. Safety assessments include vital signs, medical history, blood tests, liver function tests, and electrocardiograms before and after each treatment. Participants will continue their usual pain medications and record any additional medication use. The main outcome measured is pain intensity over 35 days, with secondary outcomes including pain qualities and analgesic consumption.

Researchers are evaluating the safety, tolerability, and how the body processes the drug iN1011-N17 after oral administration in healthy volunteers and patients with post-herpetic neuralgia (PHN). This phase 1b study also compares the bioavailability of two salt forms of iN1011-N17 (Mesylate versus Hydrochloride) in healthy volunteers. The study is designed as a randomized, double-blind, placebo-controlled trial with multiple ascending doses to better understand the drug's effects and behavior. The study consists of three parts. In Part 1, participants receive either iN1011-N17 or placebo twice daily for 7 days using different formulations (suspension or capsules). Part 2 involves a crossover design where healthy volunteers receive single doses of each salt form in two separate periods with a washout time of at least 5 days. Part 3 includes two cohorts of healthy volunteers and PHN patients randomized to receive iN1011-N17 or placebo twice daily for 14 days. Throughout, dosing occurs approximately 12 hours apart with the final dose on the morning of the last day. Participants undergo various assessments including monitoring for adverse events, physical exams, vital signs, ECGs, cardiac telemetry, and laboratory tests from baseline through follow-up periods averaging 14 to 22 days depending on the part. Additional tests evaluate drug concentration levels, metabolism, and elimination. The study also tracks pharmacokinetic and pharmacodynamic properties to assess how the drug is absorbed, distributed, metabolized, and cleared. Participants are expected to attend all visits and comply with study requirements during the treatment and monitoring phases.

Researchers are studying how muscle and brain interactions relate to neurodegenerative diseases (NDGs) such as Amyotrophic Lateral Sclerosis, Alzheimer's Disease, and Parkinson's Disease, as well as aging. The study explores whether changes at the neuromuscular junction, where muscle and nerve communicate, contribute to these conditions. It aims to identify factors that influence brain-muscle connections and how these may predict disease progression or aging outcomes. This observational case-control study includes two groups: a "Good Aging" group of adults aged 60 or older without muscle or neurological impairments, and a "Bad Aging" group with patients diagnosed with NDGs or severe acquired brain injury, some with sarcopenia or cognitive issues. Researchers will collect clinical and biological data, including biomarkers, microRNA, and extracellular vesicle analyses, to better understand the muscle-brain relationship and movement issues. Participants will undergo assessments including the Edmonton Frail Scale at the start and after six months to measure frailty changes. The study will gather neurological and muscular phenotyping data to track participants' health trajectories. The study spans from baseline to a 6-month follow-up, monitoring physical and cognitive function to inform future clinical strategies for minimizing risks linked to aging and neurological disorders.

Researchers are studying the safety and effectiveness of a single dose of nexiguran ziclumeran (NTLA-2001) compared to a placebo in people with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This phase 3, multinational, randomized, double-blind, placebo-controlled trial involves about 60 participants with this nerve disease and genetic condition affecting the peripheral nervous system. Participants will be randomly assigned to receive a single intravenous infusion of either nexiguran ziclumeran 55 mg or a placebo of normal saline. To give everyone a chance to receive the study drug, participants may switch to the other treatment group at either 12 or 18 months, depending on specific study criteria. The study is designed to compare the effects of the drug and placebo over time. During the study, participants will be monitored for nerve function using the Modified Neuropathy Impairment Score +7 (mNIS+7) over 18 months and blood levels of serum transthyretin at 29 days and 18 months. Quality of life, body mass index, and other health measures will also be evaluated. The study includes careful safety monitoring and will last up to 18 months with ongoing assessments to track participants' nerve health and overall well-being.

Researchers are evaluating three different doses of perineural dexmedetomidine—0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg—as added medicines to local anesthetics for ultrasound-guided infraclavicular brachial plexus blocks in patients undergoing upper extremity surgery at or below the elbow. The study aims to see if higher doses provide longer motor block durations, which is the main measure of the drug's effect, since pain medication and surgical trauma can influence other durations like sensory and analgesic effects. In this study, 69 patients will receive ultrasound-guided infraclavicular brachial plexus blocks with a standard local anesthetic mix including lidocaine, bupivacaine, epinephrine, and dexamethasone. They will be randomly assigned to one of three groups, each receiving a different dose of perineural dexmedetomidine added to the anesthetic solution: 0.67 mcg/kg, 1 mcg/kg, or 1.33 mcg/kg. The procedure is done before surgery with careful monitoring, and the study is blinded so patients and assessors do not know which dose is given. Participants will record the time when their motor function returns after the nerve block, and data will be collected either in person or by phone on the first day after surgery. The researchers will also assess various secondary outcomes such as sensory block duration, pain intensity, block onset, and possible side effects like respiratory depression or nerve issues. The study follows patients for up to 7 days after surgery to monitor safety and effectiveness of the different doses.

This research aims to evaluate a freezing technique called cryoneurolysis to see if it helps reduce pain in adults with trigeminal neuralgia, a condition causing severe facial pain. The study is a randomized, triple-blinded trial comparing the freezing treatment with a sham procedure to determine its safety and effectiveness. Researchers want to find out how many participants experience at least a 75% reduction in pain and will also collect other important information about pain relief and side effects. Participants will be randomly assigned to either receive the cryoneurolysis treatment or a sham stimulation device. Before treatment, all participants will keep a daily headache diary for two weeks. After treatment, they will continue recording pain for four weeks. Following this initial period, there is an extension phase lasting up to two years where all participants can receive treatment as needed. The study involves careful monitoring of pain levels and any treatment-related adverse events during weeks 1 to 4 post-intervention. During the study, participants will have their pain recorded daily using pain scales and diaries. Researchers will evaluate average daily pain intensity, responder rates based on various pain and impression scales, and safety outcomes. The study includes baseline and follow-up assessments to compare pain levels before and after treatment. Participants' ability to maintain their usual medication regime is required, and safety monitoring will continue throughout the study period. Total participation time can last up to two years with long-term follow-up opportunities.

Researchers are evaluating the effectiveness of Acceptance and Commitment Therapy (ACT)-based group therapy for improving mental health in people with mixed neurological disorders, including those with post-COVID conditions. These disorders often involve cognitive difficulties that can affect psychotherapy outcomes. This study focuses on whether the therapy improves mental health symptoms and how executive functions, especially abstract thinking, relate to social participation and mental health after therapy. The study involves an ACT-based group therapy program adapted from a manual for neurological conditions. Participants join groups of three to six people and attend eight weekly 100-minute sessions led by licensed psychotherapists. Before the therapy, participants spend eight weeks on a waiting list. The therapy uses metaphors and imagery and aims to improve psychological flexibility. Participants will be assessed before and after the waiting list period and therapy using various psychological tests and questionnaires measuring depression, anxiety, stress, and cognitive functions. Researchers will monitor therapy motivation, cognition, and language ability. The total participation includes the waiting period and therapy sessions, with outcomes measured approximately eight weeks apart to evaluate changes in mental health and executive function.

This research aims to evaluate the added effect of Amantadine or Duloxetine when combined with Pregabalin on the development of post mastectomy pain syndrome (PMPS), a common chronic pain condition occurring after breast surgery. PMPS affects 20% to 50% of patients and is a type of chronic post-surgical pain. The study investigates how these medications might influence pain pathways and nerve excitability in patients undergoing modified radical mastectomy for breast cancer. Participants are assigned randomly to one of three groups. Two hours before surgery, one group receives Pregabalin 75 mg with a placebo tablet; another group receives Pregabalin 75 mg plus Amantadine 100 mg; and the third group receives Pregabalin 75 mg plus Duloxetine 30 mg. All treatments are continued twice daily for seven days after surgery. This double-blind study compares the effect of these treatments on pain development following mastectomy. During the study, researchers will monitor the occurrence of post mastectomy pain syndrome 12 weeks after surgery as the primary outcome. Secondary outcomes include patient quality of life, activity level, pain severity at 12 weeks, and opioid use during and after surgery. Side effects related to each medication are tracked for 48 hours post-procedure. Participants are evaluated through clinical assessments and medication monitoring over the course of the treatment and follow-up period.

Researchers are evaluating the effects of combining an adductor canal block with an IPACK infiltration versus using an adductor canal block alone on post-operative pain and opioid use in patients undergoing high tibial osteotomy (HTO), distal femoral osteotomy (DFO), or tibial tubercle osteotomy (TTO). This randomized, single-blind, single-center study focuses on improving pain management after these orthopedic surgeries. Participants are randomly assigned to receive either an adductor canal block (ACB) combined with an IPACK block or an adductor canal block alone. The ACB involves injecting 15 mL of 0.25% Bupivacaine under ultrasound guidance to block the saphenous nerve, while the IPACK block administers 20 mL of 0.25% Bupivacaine into the space between the popliteal artery and the knee capsule. These treatments are given around the time of surgery to assess their impact on post-operative pain and opioid consumption. During the study, researchers will measure opioid use during the first 24 hours after surgery as the primary outcome. Secondary outcomes include pain scores reported by patients at various time points up to six months after surgery, length of stay in the post-anesthesia care unit, and physical function scores related to knee injury and osteoarthritis. Participants will be monitored for safety, pain control, and recovery progress throughout the post-operative period and follow-up visits up to six months after surgery.

This research aims to understand neuropathic pain in children and adolescents who had limb amputations during childhood. It focuses on two types of neuropathic pain: phantom limb pain and residual limb pain. The study also looks at quality of life and functional independence in these young patients, exploring links between pain, autonomy, quality of life, and age when the amputation occurred. This observational study uses both past medical records and questionnaires to gather information without changing patient care. Participants are children and teens aged 5 to 18 years who had limb amputations before age 15 for girls and 16 for boys. The study collects data from medical records and standardized questionnaires during routine follow-up visits at a specialized pediatric limb anomaly center. There is no treatment or intervention; data collection happens at a single time point to assess neuropathic pain and its effects. During the study, participants provide information through questionnaires about neuropathic pain, quality of life, and functional abilities. Researchers also review medical records for relevant history. The main measure is the presence of neuropathic pain after amputation. Other outcomes include types of pain, health-related quality of life, locomotor and upper limb function, and correlations between pain scores and age at amputation. Participation involves only one visit during routine care, with no extra procedures or treatments.