Nerve Injury

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 quality of 3D hand modelization using the EOS imaging system compared to the standard computed tomography CT scans. The study focuses on patients who require CT imaging of the hand or wrist to assess the accuracy and potential benefits of the EOS imaging device. Participants will undergo EOS hand imaging, and these images will be compared directly with their standard CT images. The primary goal is to collect and analyze data from both imaging methods at 60 days to determine how well the EOS system performs in creating 3D models of the hand. During the study, participants will have imaging procedures and data collection focused on the hand or wrist area. Researchers will monitor and compare the imaging outcomes from both EOS and CT methods. The total participation duration includes data evaluation at day 60, with no additional treatment or long-term follow-up specified.

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.

This research aims to evaluate interventions to support family members who act as surrogate decision makers for critically ill patients in Intensive Care Units ICUs. These surrogates often face intense grief and stress that can affect their mental health and the quality of decisions made for their loved ones near end-of-life. The study focuses on reducing symptoms of prolonged grief disorder PGD, post-traumatic stress disorder PTSD, and related emotional challenges through a psychological intervention called EMPOWER. The study compares two approaches the EMPOWER intervention, which is a brief, cognitive-behavioral and acceptance-based treatment delivered by trained mental health professionals, and a Supportive Conversation SC that provides empathetic support without specific skill-building. EMPOWER includes six 15-minute modules and two booster phone sessions, totaling about 90 minutes plus follow-ups, while the Supportive Conversation matches this time with supportive interaction and follow-up calls. Participants are assessed up to four times before and after the intervention within three months. Participants, who are surrogate decision makers of ICU patients near end-of-life, will complete assessments on grief, PTSD, depression, regret, anxiety, and distress before the intervention, immediately after, and at 3 and 12 months follow-up. The study also includes interviews with some participants to better understand the interventions effects and contextual factors during the COVID-19 pandemic. The primary outcomes focus on changes in grief and PTSD symptoms over twelve months, with safety and mental health monitored throughout the study period.

This trial evaluates treatments for peripheral nerve injuries with gaps between 0.5 and 3.0 cm in adults aged 18 to 80. Researchers compare the efficacy of the NeuroSpan Bridge device against the NeuraGen Nerve Guide and Nerve Autograft in repairing nerve discontinuities. The study is conducted as a multicenter, prospective, randomized, double-blinded clinical trial to assess treatment outcomes and safety. Participants receive one of three nerve repair treatments based on the size of their nerve injury. Those with injuries 0.5 to 1.0 cm receive the NeuraGen Nerve Guide, a resorbable implant that supports nerve repair. Injuries 1.1 to 3.0 cm are repaired using a nerve autograft, transplanting the patients own sensory nerve tissue. The NeuroSpan Bridge, a novel scaffold device designed to mimic natural nerve architecture and support axonal growth across nerve gaps, is also being studied as a treatment option. Throughout the 12-month study period, participants are assessed for nerve function and safety outcomes. Measurements include static two-point discrimination, motor and sensory function grading, moving two-point discrimination, and scores from the Disabilities of the Arm Shoulder and Hand DASH questionnaire. Safety monitoring covers complications such as infections, inflammation, tissue rejection, neuroma formation, chronic pain, and device malfunctions. The trial aims to gather comprehensive data on the effectiveness and safety of these nerve repair methods.

Researchers are evaluating the effectiveness of a smart upper limb rehabilitation system combined with exoskeleton robot devices and an Internet of Things IoT application for home-based training in patients recovering from stroke and those with spinal cord injuries. The study aims to improve motor function, daily living activities, and quality of life by remotely monitoring rehabilitation progress and assisting patient movements. Participants are adults aged 20 to 79 years with specific cognitive and physical criteria depending on their condition. Participants are randomly assigned to one of two groups the TIGER group, which uses a tenodesis-induced-grip exoskeleton robot system, or the TOT group, which receives task-oriented training. Each group follows a home-based training program for 4 weeks. For stroke patients, training is 30 minutes twice daily, 5 days a week for spinal cord injury patients, training is 40 minutes once daily, 5 days a week. The TIGER system offers passive range of motion warm-up and functional training, while the TOT group practices sensorimotor techniques and functional tasks. Participants will undergo assessments before and after the intervention, including motor function tests like the Fugl-Meyer Assessment and Box and Block Test, range of motion measurements, and quality of life evaluations. Researchers will monitor progress in motor activity, independence, and satisfaction with assistive technology. The total study duration spans from baseline through 4 weeks of training, with outcome measures collected at baseline and after the intervention period.

Researchers are studying brain activation patterns in stroke patients during mirror movement to understand upper limb function. This observational study focuses on patients who have had their first stroke, either cerebral infarction or cerebral hemorrhage, with specific muscle strength and muscle tone conditions. The study takes place in a hospital rehabilitation ward where patients receive detailed information and provide informed consent before participation. The study involves two types of hand movements mirror image and healthy hand movement. In the mirror image intervention, patients place their affected hand in a mirror box and observe the reflection of the healthy hand moving, imagining the affected hand performing the same actions. In the healthy hand movement intervention, patients quickly open and grasp their healthy hand while focusing on the affected hand. The primary outcome is brain activation measured by functional near-infrared spectroscopy fNIRS after one week of hand function rehabilitation training. Participants will be closely monitored throughout the trial with full communication and support from the research team. The study involves observing brain activation and hand movement activity with attention to patients questions and responses. The total participation period includes the initial week of rehabilitation training followed by assessments to measure the brains response to the interventions.

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 mNIS7 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 conducting a multicenter, randomized study to compare two nerve repair methods for people needing reconstruction of mixed or motor nerves in the upper arm or hand. The study focuses on evaluating the recovery of motor and sensory functions after nerve injury using either the Avance Nerve Graft or the patients own sural nerve autograft. This study aims to determine whether the Avance Nerve Graft is not less effective than the autograft method. Participants will be randomly assigned to receive either the Avance Nerve Graft, a sterile nerve scaffold made from human nerve tissue, or a sural nerve autograft, which uses nerve tissue harvested from the patients lower leg during surgery. The study includes a screening visit, an operative visit for the nerve repair, and nine follow-up visits spread over two years at Week 4, and Months 3, 6, 9, 12, 15, 18, 21, and 24 to monitor recovery. Throughout the study, participants will undergo assessments of motor and sensory function using the MRCC score at each follow-up visit. Additional measures include recovery milestones, treatment response, and functional disability scores for the upper and lower extremities. Participants are expected to comply with the study schedule for 24 months, during which safety and recovery outcomes will be closely monitored by the research team.