Safety and Efficacy of Autologous Human Schwann Cell (ahSC) Augmentation in Severe Peripheral Nerve...
Peripheral Nerve InjuryThe primary purpose of this research study is to evaluate the safety and possible harms of injecting one's own Schwann cells along with nerve auto-graft after a severe injury to a major nerve has occurred.
Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries
Peripheral Nerve InjuriesNTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years of age.
Long Term Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative...
PainPain Syndrome11 moreOver the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the long term efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to traumatic or post-operative peripheral neuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to traumatic or post-operative peripheral neuropathy.
A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections...
Moderate to Severe Chronic Peripheral Neuropathic Pain (PNP) Due to Postherpetic Neuralgia (PHN) or Peripheral Nerve InjuryIn this clinical trial, participants with nerve pain after shingles or nerve injury will receive injections with NT 201 or placebo. The purpose is to measure the decrease of nerve pain with NT 201 compared to placebo. Trial details include: Trial duration: 22-23 weeks; Treatment duration: 1 injection visit with a 20-week follow-up period; Visit frequency: 2 remote visits by phone/video call (1 week and 12 weeks after the injection); 2 on-site visits (6 weeks and 20 weeks after the injection).
Non-invasive Therapy to Drive Nerve Regeneration
Peripheral Nerve InjuriesPeripheral nerve injuries are common and often associated with poor outcomes including incomplete repair, debilitating pain states and compromised function. Although nerve regeneration can be enhanced by brief electrical nerve stimulation at the time of or before surgical repair in rodents and humans, this approach is invasive. Acute intermittent hypoxia, breathing alternate cycles of regular air and air with ~50% normal oxygen levels (11% O2) is an emerging, promising non-invasive therapy promoting respiratory and non-respiratory muscle function in spinal cord injured rats and humans. Because the entire body is exposed to this therapy, it has the potential to globally impact the nervous system beyond just controlling respiratory and leg function in spinal cord injured patients. Thus, the investigators hypothesized that an acute intermittent hypoxia paradigm similar to that used for spinal cord repair will improve peripheral nerve repair in a manner akin to electrical stimulation, including its impact on expression of regeneration-associated proteins - a predictor of nerve growth states. In recent studies the investigators found this to be the case and now propose to continue these promising studies by performing a pilot clinical trial evaluating this form of treatment on patients with compromised hand function due to severe carpal tunnel syndrome. The goal is to improve nerve repair outcomes in the least invasive and optimal manner.
Interhemispheric Connectivity and Compensation
Peripheral Nerve Injury Upper LimbHealthyThe goal of this study is to determine which parts of the brain make it possible for some people to move skillfully with their left non-dominant hand.
StimRouter Registry Clinical Protocol
Chronic PainPeripheral Neuropathy5 moreThis Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.
Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction...
Peripheral Nerve InjuriesThis study is a registry of general use of Avance Nerve Graft and is intended to evaluate the uses, response rates, and safety of Avance Nerve Graft in the real-life clinical setting. Optional addendums 1 and 2 included in the protocol are intended to establish comparative groups and focused subgroups within the registry.
Efficacy and Tolerability of AP707 in Patients With Chronic Pain Due to Traumatic or Post-operative...
PainPain Syndrome11 moreOver the last years a rising medical need for treatment of chronic pain was identified. Based on previous findings indicating the pain modulating effects of cannabinoids in chronic pain disorders, this clinical trial investigates the efficacy and tolerability of the THC-focused nano endocannabinoid system modulator AP707 in patients with chronic pain disorders due to traumatic or post-operative peripheral neuropathy. Patients receive AP707 or placebo over the course of 14 weeks as an add-on to the standard of care. Changes in pain intensity, quality of life and sleep and others measures are monitored through different scales to assess the efficacy of AP707 in patients with chronic pain due to traumatic or post-operative peripheral neuropathy.
Autologous Human Schwann Cells in Peripheral Nerve Repair
Peripheral Nerve InjuriesThe purpose of this study is to assess the safety of autologous human Schwann cell (ahSC) augmentation of nerve autograft repair in participants with severe peripheral nerve injury (PNI). For humans with acute severe PNI, the hypothesis is that augmentation of nerve autograft repair with ahSCs can potentially enhance axonal regeneration and myelin repair and thus improve functional recovery.