Spinal cord injuries are anatomically mostly incomplete, showing tissue bridges of the spinal cord at the injury site. Of the 60% functionally incomplete patients, about half face a life in the wheelchair. Besides conventional rehabilitation, no prominsing further treatment options exist. One of the most plastic systems involved in locomotion is the pontomedullary reticulospinal tract, which is the oldest locomotor command system existing in most vertebrates, including primates. Muscle activation patterns for limb movements are programmed in the spinal cord and have to be activated and coordinated through commands from the so called mesencephalic locomotor region (MLR). The MLR consists of nerve cells in the lower mesencephalic tegmentum sending uni- and bilateral signals through the medullary reticulospinal tracts. Classical physiological studies showed that electrical stimulation of the MLR induce locomotion. For the first time this approach was transferred and recently published in a model of induced incomplete spinal cord injury by the Schwab group. Rats severly impaired in motor hindlimb control with only 10-20% spared white matter, recovered with fully functional weight bearing locomotion under MLR deep brain stimulation (DBS). Even rats with only 2-10% spared white matter regained weight supporting stepping. DBS is a clinical standard treatment option in patients with movement disorders but does not relieve all symptoms. Therefore, small studies of MLR stimulations have been safely used in Parkinsonian patients showing freezing of gait and frequent falls with variable results. In a translational approach, we aim at performing a multidisciplinary phase one clinical trial with 5 patients and incomplete spinal cord injury. With the means of our established universitary setup for DBS treatments the operations will be performed unilaterally under local anaesthesia in the Division of Neurosurgery, USZ, with perioperative electrophysiological recordings, clinical assessments and gait analysis under test stimulation in the Spinal Cord Injury Center Balgrist.
Informed Consent
Participation in two assessment sessions before enrollment (Screening and baseline)
Willingness and ability to comply with the protocol and to attend required study training and visits
Male or female subjects
Enrollment of the investigator, his/her family members, employees and other dependent persons
Limitation of standing and walking function based on accompanying (CNS) disorders
Cardiovascular disorders restricting physical training or peripheral nerve disorders
Implanted technical devices (pacemaker, defibrillator)
Single group
Deep brain stimulation in mesencephalic locomotor region
Procedure/SurgeryImplantation of Electrodes in the Mesencephalic Locomotor Region for improvement of Locomotion and Gait
Implantation of a Deep brain stimulation system
DeviceImplantation of a Medtronic Percept PC Impulse Generator for chronic Stimulation of the selected target.
Change in 6 Minute Walk Test at baseline and 6 months post intervention
Standardized test. Patient is asked to walk for 6 minutes. Result is the distance covered
Change in 10 Meter Walking Test towards baseline
Standardized test. Patient is asked to walk 10 meters as quickly as possible. Result is the speed (m/s)
Change in Timed Up and Go test (TUG) towards baseline
Standardized test. Patient is asked to stand up from a sitting into Standing Position and walk 3 m and return to seated position. Result ist time.
Kinematic assessment during overground and treadmill walking
Individuals are secured using the FLOAT.
Change in Spinal cord Independence measure (SCIM III) towards baseline
Standardized tool measuring the degree of independence of the subject. Result is score.
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University of Zurich
Lead sponsor
Balgrist University Hospital
Collaborator
ETH Zurich
Collaborator
Wings for Life
Collaborator
