Study nurse involved in translational clinical trials for patients suffering from spinal cord injuries.
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The study nurse position awarded by the Balgrist Foundation has over the last two years managed the application and approval of three major translational clinical trials in human spinal cord injuries. The studies are all phase 1/phase 2 studies and require an enormous amount of effort and a wide set of skills to initiate, to approve and to plan the clinical trials. The hired study nurse has been very skillful and sensitive in managing these projects together with the clinical PI. The following paragraphs give a brief overview of the clinical trails the nurse is involved in:
1. NISCI (Nogo-A Inhibition in acute Spinal Cord Injury)
NISCI (Nogo-A Inhibition in acute Spinal Cord Injury) is a multicenter (6 sites in EU and 1 CH), multinational, placebo controlled phase-II study for the safety and efficacy of intrathecal anti-Nogo-A [NG101] in patients with acute cervical spinal cord injury. The purpose of the NISCI trial is to test if an antibody therapy can improve motor function and quality of life of tetraplegic patients. Recent preclinical research in animal models succeeded in greatly enhancing axonal sprouting, fiber regeneration and neuroplasticity following injuries of the brain and spinal cord. These results now warrant translation to patients suffering from acute spinal cord injuries. A previous phase I clinical study using an intrathecal application of a nerve fiber growth promoting an antibody against the growth inhibitory protein Nogo-A, has shown in patients with complete spinal cord injury that this treatment is safe and well tolerated. The present study will enroll patients (male or female age 18-70) with various degrees of complete to incomplete acute spinal cord injury for a double-blind, placebo-controlled trial to test the efficacy of this antibody therapy to improve motor outcome and quality of life. Within 30 days patients will receive 6 intrathecal injections of either the trial drug or a placebo. Several assessments and rehabilitations will take place at the specialist Center for Spinal Cord Injury. The study will last about 6 months for each individual participant.
STIMO is a First-in-Man (FIM) study with the objective to confirm the safety and feasibility of a closed-loop Epidural Electrical Stimulation (EES) in combination with overground robot assisted rehabilitation training for patients with chronic incomplete spinal cord injury (SCI), as it has previously been demonstrated successfully in animals. The study will last about 9-11 months for each individual participant, from signing informed consent to the final test in the study. Rehabilitation training and final evaluation takes place in Lausanne and 1 day in Zurich. During this phase, the patients receive intensive overground rehabilitation training using a body weight support device in combination with EES, with the aim of improving the walking capabilities of the patient significantly. At the end of the protocol, the study aims to make the patients walk better and faster, as is quantified through the pre-defined measures which are assessed prior to implant and at the end of the study. As this is the first study of its kind, success is not guaranteed, but the potential benefits outweigh any of the potential risks.
3. Deep Brain Stimulation
Deep brain stimulation in patients with incomplete spinal cord injury (DBS-SCI). This phase I/II open-label trial will be performed to evaluate safety and preliminary efficacy of unilateral deep brain stimulation of the mesencephalic locomotor region in patients with incomplete spinal cord injury. Male or female subjects (18-75 year-old) with completed in-patient rehabilitation will be enrolled for screening evaluations at a minimum of 5 months post-injury. DBS operation will be performed not earlier than 6 months post-injury. Primary endpoints will be improvement of posture or locomotion as determined by functional tests validated in spinal cord injury trials, such as the 6 Minute Walk Test, Timed Up and Go Test, Spinal cord independence Measure (SCIM III) and the Walking Index for Spinal Cord Injury (WISCI II).
Embedment in Balgrist research
In the Spinal Cord Injury Center, University Hospital Balgrist, research is a central part in the development of new clinical treatments. As of yet there are no available treatments for a damaged spinal cord and there is an unmet need for discovering new treatment options for patients with spinal cord injuries. One of the options is the treatment with antibodies against inhibitory factors that are built into the adult human central nervous system. A phase 1 clinical study has shown the safety and feasibility of the application of an antibody into the cervical spinal fluid. The next study will be a phase 2 study in patients with complete and incomplete cervical spinal cord injuries. This will be the first inman study of this kind worldwide. To the same extent we are looking at spinal cord repair and neuroplasticity modern technics coming out of engineering that are focussing an electrical stimulations of the central nervous system to improve motor outputs. In this context we are running and aim to run two clinical studies, one of which is applying epidural spinal stimulation at the spinal cord level (together with EPF Lausanne). The second one is a deep brain stimulation in conjunction with the Department of Neurosurgery, University Hospital Balgrist. Both studies will apply a very specific electrical current to the central nervous system. The principal technical procedures are in alignment with other clinical treatment procedures such as spinal cord stimulation against pain and deep brain stimulation in patients suffering from Parkinson, however so far this has not yet been applied in humans. These trials are phase 1 clinical trials to approve the feasibility and safety of these procedures in patients with spinal cord injuries.
The above mentioned clinical studies are highly innovative, they have phase 1/phase 2 characters. They are the first inman applications and they are studies that are almost unique to Zurich, Switzerland and they are world leading for its kind.
Both of the clinical trials to improve neuroplasticity in patients with SCI as well as the electrical stimulation procedures aim to improve the functional outcome of patients with spinal cord injuries. These functions are targeted in both the upper and the lower limb functions:
• The lower limbs to stand and walk
• The upper limbs to enable the use of hands for self care and other activities of daily life