Neuropathy

This research aims to evaluate the outcomes of surgically treated acute traumatic peripheral nerve injuries in the upper extremity, focusing on their long-term effects on sensory and motor functions, overall functional status, and quality of life. The study observes patients with nerve damage resulting from trauma to the nervous system, particularly injuries involving the median, ulnar, radial nerves, or combinations of these. Participants will undergo standard clinical and functional assessments to monitor the status of their nerve injuries. These assessments include evaluating motor and sensory functions and overall hand functionality without being assigned to a specific treatment. The study observes different nerve injury types such as ulnar nerve, median nerve, or combined injuries. During the study, participants will be evaluated at six months after injury using tools like the Michigan Hand Outcomes Questionnaire to assess hand function, grip strength measured by a dynamometer, Semmes-Weinstein monofilament test for sensation, and static two-point discrimination test. The study period involves regular clinical and functional evaluations to track recovery and impact on quality of life over time.

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 studying the potential effects of 4-aminopyridine (4-AP) on recovery after peripheral nerve injuries caused by traction or crush. The study focuses on men with prostate cancer undergoing robot-assisted radical prostatectomy, as nerve injury during this surgery may lead to erectile dysfunction and urinary continence issues. This research aims to test whether 4-AP can speed up the often slow and unpredictable recovery process after such nerve injuries. Participants will receive either FDA-approved 10 mg 4-aminopyridine tablets or placebo tablets after surgery. The medication is taken orally, with a maximum of two tablets per 24 hours, and must be swallowed whole without breaking or crushing. The treatment period lasts for 60 days following surgery. The placebo is designed to look like the active drug, and participants will be reminded not to take other aminopyridine medications during the study. Throughout the study, participants will be monitored for changes in urinary incontinence and erectile function using standardized questionnaires every seven days for six months. They will also keep a daily drug diary for 90 days and complete sexual activity questionnaires regularly. The study includes follow-up for up to one year to assess recovery progress and safety. The total participation time involves regular assessments and monitoring after the surgery.

Researchers are evaluating the role of a single dose of 4-aminopyridine (4-AP) to help diagnose whether nerve injuries from peripheral nerve traction or crush are complete or incomplete. The study aims to speed up the identification of nerve continuity compared to standard electrodiagnostic and clinical assessments. This is a phase 2, randomized, double-blind crossover trial conducted at a single center. Participants will be randomized to receive either a 10 mg dose of 4-aminopyridine followed by a placebo, or placebo followed by the drug, with the order determined randomly. Each participant undergoes baseline sensory and motor testing, blood sampling, and then hourly testing for three hours after each dose to assess sensory and motor function, electrodiagnostic results, and serum 4-AP levels. After completing both treatment arms, testing concludes. Following initial testing, participants will be monitored for 20 weeks with follow-up visits at 2, 6, 12, 18, and 20 weeks, including physical exams and phone interviews at 9 and 15 weeks to assess subjective motor and sensory function. The main outcome measured is the subjective return of sensation during dosing and at various post-injury time points. Each visit or call lasts about 30 minutes.

Researchers are evaluating the use of 64Cu-DOTATATE PET/CT/MRI imaging to improve diagnosis and monitoring of Lyme neuroborreliosis (LNB), a tick-borne infection affecting the nervous system. This study aims to compare patients clinically suspected and cerebrospinal fluid (CSF) verified with LNB against those suspected without CSF verification. The goal is to see if this imaging technique can provide more precise diagnosis, prognostic information, and risk assessment for lingering symptoms after treatment. The study involves 50 patients divided into two groups: 25 with possible or confirmed neuroborreliosis and 25 investigated but with normal CSF results. Participants will undergo 64Cu-DOTATATE PET/CT/MRI scans, which target activated macrophages involved in infection. This non-invasive imaging method is being assessed for its diagnostic value and ability to support follow-up six months after treatment, alongside blood biomarker testing including sCD163, NfL, and Tau. During the study, participants will have PET/CT/MRI scans to measure tracer uptake in the central nervous system and reference organs. Clinical symptoms, laboratory markers, and imaging results will be tracked to evaluate disease activity and prognosis. The primary outcomes focus on diagnostic performance over 2.5 years, with secondary measures also assessed. The study monitors patients without interventions beyond imaging and biomarker collection, lasting from initial evaluation through follow-up visits.

Researchers are investigating the relationship between amylin, a hormone increased in people with Type-2 diabetes, and peripheral neuropathy symptoms in patients with this condition. The study explores whether the amount of amylin in the upper limbs correlates with the severity of nerve damage symptoms. This observational study aims to better understand how diabetes-related vascular damage affects nerve function and may identify biomarkers for disease severity. Participants will provide blood samples and skin biopsies from the forearm to measure amylin deposition in blood vessels and red blood cells. The study also includes nerve conduction velocity tests and sensory assessments of pain and temperature response in the upper extremities. These tests occur at the time of sample collection and follow-up sensory testing one week later. Throughout the study, participants undergo clinical sensory exams, nerve conduction velocity testing, and pain threshold evaluations using pressure, cold, and heat stimuli. Researchers will compare amylin levels to symptom severity and nerve function. The study collects data at single time points and includes follow-up sensory testing to provide preliminary insights for larger trials. Total participation involves initial testing and follow-up assessments one week later.

Researchers are evaluating Claseprubart (DNTH103) in adults with multifocal motor neuropathy (MMN) to assess its safety, tolerability, pharmacometrics, and effectiveness. This Phase 2 randomized, double-blinded, placebo-controlled study aims to better understand how this drug works for people with MMN and to monitor any treatment-related side effects. The sponsor of this trial is Dianthus Therapeutics. Participants receive either Claseprubart or a placebo. On the first day, they get an intravenous loading dose, followed by subcutaneous doses every two weeks from Week 1 to Week 15. The study includes multiple groups receiving either 300 mg or 600 mg doses of Claseprubart, or placebo, to compare outcomes. This design helps researchers evaluate different doses and their effects. During the study, participants will be closely monitored from baseline up to Week 17 for side effects and treatment response, including grip strength, muscle function scores, disability scales, and quality of life measures. Some assessments continue up to Week 52 in an open-label extension period. Blood samples will be collected to analyze drug concentration and immune responses. Safety and effectiveness data are gathered through various clinical tests and questionnaires, ensuring comprehensive participant evaluation throughout the study.

Researchers are evaluating a fruit and vegetable prescription (F&V Rx) program designed to improve diabetes management among low-income Hispanic adults with type 2 diabetes. The study aims to test how F&V prescriptions affect participation in diabetes self-management education and support (DSME/S), fruit and vegetable intake, diet quality, blood sugar control measured by hemoglobin A1c, and the program's acceptability and sustainability. This pilot randomized controlled trial addresses gaps in understanding the role of F&V prescriptions combined with DSME/S attendance in diabetes care. The study includes three groups: one receiving usual care, one receiving usual care plus four monthly F&V Rx vouchers regardless of DSME/S attendance, and one receiving usual care plus F&V Rx vouchers contingent on monthly DSME/S group attendance over 16 weeks. Participants in the intervention groups receive vouchers to purchase fruits and vegetables at local stores. The trial tests the impact of these approaches on education uptake and retention as well as health and dietary outcomes. Participants will attend study visits at the beginning and end of the 16-week period for assessments including blood samples for A1c and plasma carotenoids, dietary intake surveys, and diabetes self-management questionnaires. Researchers will monitor voucher use, DSME/S attendance, and collect feedback from both participants and care providers to evaluate program implementation. The study is conducted with cultural adaptations and community involvement to support relevance for Hispanic adults with type 2 diabetes.

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 investigating the effects of a multidomain lifestyle intervention to slow cognitive decline and dementia risk in elderly residents aged 60 to 80 in Zhejiang Province, China. The study builds on findings from Finland, where a similar approach combining physical activity, nutrition, cognitive training, social activities, and vascular risk management showed promise in healthy older adults at risk of cognitive decline. This trial aims to explore how such an intervention may change brain structure and function as well as cognitive abilities in an Asian population. Participants are randomly assigned to either a structured multidomain intervention group or a self-guided control group. The intervention group receives tailored nutritional guidance, cognitive training, physical exercises, and vascular risk monitoring, all adapted to Chinese cultural norms. The control group receives regular health education campaigns and basic health monitoring every 6 to 12 months. This trial runs for two years with ongoing assessments to evaluate the impact of these lifestyle changes. During the study, participants undergo various evaluations including cognitive tests measuring global and domain-specific cognition, neuroimaging scans like MRI and fMRI, laboratory blood tests, and physical performance measures such as grip strength and gait speed. Questionnaires assess quality of life, depression, sleep quality, and daily activities. Researchers also monitor cardiovascular health, dementia onset, and falls. This comprehensive monitoring will help determine the intervention's effects on brain health and daily functioning over the 24-month period.