Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait
A Phase I/II Open-label Multicenter Trial to Evaluate Safety and Preliminary Efficacy of Unilateral Deep Brain Stimulation of the Mesencephalic Locomotor Region in Patients With Incomplete Spinal Cord Injury
University of Zurich
5 participants
Mar 15, 2018
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria13
- 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
- Age 18-75
- Motor incomplete SCI
- Level of lesion: T10 and above, based on AIS level, preservation of sacral function
- Focal spinal cord disorder caused by either trauma or non-traumatic and non-progressive condition (like hemorrhage, benign tumor)
- Minimum 3 months of recovery after SCI
- Completed in-patient rehabilitation program
- WISCI II, level >2 (0-20 items): assistance of one or more persons. Ability to walk at least 10 meters
- Stable medical and physical condition.
- Adequate care-giver support and access to appropriate medical care in patient's home community
Exclusion Criteria16
- 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)
- History of significant autonomic dysreflexia
- Cognitive disorders/brain damage
- Drug refractory epilepsy
- Severe joint contractures disabling or restricting lower limb movements
- Haematological disorders with increased risk of bleeding during surgical interventions
- Participation in another study with investigational drug within the 30 days preceding and during the present study
- Congenital or acquired lower limb abnormalities (affection of joints and bone)
- Women who are pregnant or breast feeding or planning a pregnancy during the course of the study
- Lack of safe contraception
- Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological problems, dementia etc.
- Known or suspected non-compliance, drug or alcohol abuse
- Current or prior malignancy
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Interventions
Implantation of Electrodes in the Mesencephalic Locomotor Region for improvement of Locomotion and Gait
Implantation of a Medtronic Percept PC Impulse Generator for chronic Stimulation of the selected target.
Locations(1)
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NCT03053791