Deep brain stimulation to help walking after incomplete spinal cord injury

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a motor incomplete spinal cord injury who can walk at least 10 meters with help. It tests deep brain stimulation in the mesencephalic locomotor region on one side of the brain to improve walking.

Age

18 to 75 years

Sex

Male or female

Disease stage

Motor incomplete spinal cord injury at level T10 or above (AIS level), with sacral function preserved. The cause is trauma, or a non-progressive condition such as bleeding or a benign tumor. At least 3 months of recovery since the injury. WISCI II level above 2: walks at least 10 meters with help from one or more persons. Stable medical and physical condition.

Earlier treatment

Must have completed an in-patient rehabilitation program. Cannot join after taking an investigational drug in another study in the 30 days before the trial.

Main reasons for not taking part

• Other nervous system disorders, heart problems or nerve disorders that limit standing, walking or training
• Implanted devices such as a pacemaker or defibrillator
• Cognitive disorders, brain damage, epilepsy not controlled by drugs, or significant autonomic dysreflexia
• Blood disorders that raise bleeding risk in surgery, or current or past cancer
• Pregnancy, breastfeeding, planning a pregnancy, or no safe contraception

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 75 years old?YesNo

What the trial wants to find out

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.

The group in the trial

• Intervention groupTreatment being tested

  Single-armed study. All patients will receive treatment.

  Treatment: Deep brain stimulation in mesencephalic locomotor region and Implantation of a Deep brain stimulation system