Actively Recruiting
Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait
Led by University of Zurich · Updated on 2024-08-28
5
Participants Needed
1
Research Sites
506 weeks
Total Duration
On this page
Sponsors
U
University of Zurich
Lead Sponsor
B
Balgrist University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Deep Brain Stimulation in Patients With Incomplete Spinal Cord Injury for Improvement of Gait
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent given
- Participation in two assessment sessions before enrollment (screening and baseline)
- Willingness and ability to follow the study protocol and attend all required visits and training
- Male or female subjects
- Age between 18 and 75 years
- Motor incomplete spinal cord injury
- Level of lesion at T10 or above with preserved sacral function
- Spinal cord disorder caused by trauma or non-progressive conditions like hemorrhage or benign tumor
- At least 3 months and no more than 2 years since spinal cord injury
- Completed in-patient rehabilitation program
- WISCI II level greater than 2; able to walk at least 10 meters with assistance
- Stable medical and physical condition
- Adequate caregiver support and access to medical care at home
You will not qualify if you...
- Investigator or their family, employees, or dependents enrolled
- Standing or walking limitations due to other central nervous system disorders
- Cardiovascular or peripheral nerve disorders restricting physical training
- Presence of implanted technical devices like pacemaker or defibrillator
- History of significant autonomic dysreflexia
- Cognitive disorders or brain damage
- Drug-resistant epilepsy
- Severe joint contractures limiting lower limb movement
- Blood disorders increasing surgical bleeding risk
- Participation in another investigational drug study within 30 days before or during this study
- Congenital or acquired lower limb abnormalities affecting joints or bones
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Lack of safe contraception
- Inability to follow study procedures due to language, psychological, or cognitive problems
- Known or suspected non-compliance, drug or alcohol abuse
- Current or prior cancer
AI-Screening
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Trial Site Locations
Total: 1 location
1
Balgrist University Hospital
Zurich, Switzerland, 8008
Actively Recruiting
Research Team
L
Lennart H Stieglitz, MD
CONTACT
I
Iris Krüsi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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