Clinical trial NCT03441256: Motor, Sensory, and Autonomic Function in Traumatic Spinal Cord Injury After the LION Procedure.
Official title: Motor, Sensory, and Autonomic Function After Laparoscopic Implantation of Neuroprosthesis - a Randomized Controlled Trial of the LION Procedure in Traumatic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: Spinal Cord Injury Centre of Western Denmark
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
name: Regionshospitalet Viborg, Skive
name: University of Southern Denmark
First posted: 2018-02-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Possover pioneered a minimally invasive and fully reversible laparoscopic technique, laparoscopic implantation of neuroprosthesis (LION), for precise placement of an implantable pulse generator and one to four leads for stimulating nerves of the lumbosacral plexus.

Unexpectedly, Possover in 2014 made the clinical observation that four patients with complete and incomplete chronic traumatic spinal cord injury regained significant motor and sensory function following the LION procedure for bladder and bowel dysfunction.

The primary objective of this randomized clinical trial is to investigate whether the LION procedure and the subsequent neurostimulation in individuals with chronic traumatic thoracolumbar spinal cord injury with spastic paraplegia is associated with increased walking capacity.

Detailed description: Sustaining a spinal cord injury impacts the mental and physical wellbeing of the injured individuals profoundly; quality of life suffers and subsequently the risk of suicide is greatly increased as compared to the general population. While spinal cord injury compromises an individual's mobility, dependency does not necessarily ensue; most individuals will require a wheelchair, braces or other assistive devices for maintaining activities of daily living and participating in society i.e. work, sport etc.

Furthermore, individuals with spinal cord injury face numerous medical complications and reduced life expectancy as a direct result of their disability.Detrusor over-activity and sphincter dyssynergia are seen in up to 85% of cases and improved control of micturition and defaecation closely follows restoration of ambulation as primary rehabilitation goals of patients with spinal cord injury.

Recovery after initial inpatient rehabilitation is at best modest and conversion rate of the American Spinal Injury Association Impairment Scale grade remain poor for grades A and B. Likewise, the rate of motor improvement stagnates over time leaving many patients with permanent motor, sensory and autonomic deficits. 9-12 months after their initial injury, most patients have essentially exhausted their possibility of further restorative treatments.

Possover pioneered a minimally invasive and fully reversible laparoscopic technique, laparoscopic implantation of neuroprosthesis (LION), for precise placement of an implantable pulse generator and one to four leads for stimulating nerves of the lumbosacral plexus; a significant number cases suggest this technique is safe and efficacious in treating overactive and atonic bladder disturbances, neurogenic bowel dysfunction, and abdominopelvic neuropathic pain.

Unexpectedly, Possover in 2014 made the clinical observation that four patients with complete and incomplete chronic traumatic spinal cord injury regained significant motor and sensory function following the LION procedure for bladder and bowel dysfunction. Expanding further on the topic, Possover have recently published an updated case series of 18 patients om whom 16 are now capable of weight bearing standing and 12 are furthermore capable of voluntary stepping.

The primary objective of this randomized clinical trial is therefore to investigate whether the LION procedure and the subsequent neurostimulation in individuals with chronic traumatic thoracolumbar spinal cord injury with spastic paraplegia is associated with increased walking capacity.

Eligibility criteria: Inclusion Criteria:

1. Willing and able to give informed consent for participation in the clinical investigation, and to comply with all requirements of the clinical investigation
2. Traumatic SCI with:

   * neurological level below T5 and above L2
   * American Spinal Injury Association Impairment Grade A or B
   * spasticity in one or both lower extremities
   * Injury prior at least 12 months prior to enrollment

Exclusion Criteria:

1. Female subject who is pregnant/planning pregnancy during the clinical investigation.
2. Previous surgery/procedures interfering with the LION procedure incl. the presence of other implanted medical devices.
3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the clinical investigation, or may influence the result of the clinical investigation, or the subject's ability to participate in the clinical investigation

Primary outcomes:
measure: Improvement/change in walking capacity
timeFrame: Baseline, 3 mo., 6 mo., 9 mo., 12 mo.
Secondary outcomes:
measure: Change in lean body mass
timeFrame: Baseline, 12 mo.
measure: Change in distal motor latency of motor nerve conduction studies
timeFrame: Baseline, 12 mo.
measure: Change in peak-peak amplitude of motor nerve conduction studies
timeFrame: Baseline, 12 mo.
measure: Change in muscle microarchitecture
timeFrame: Baseline, 12 mo.
measure: Change in muscle motor unit number
timeFrame: Baseline, 12 mo.
measure: Change in compound muscle action potential scans.
timeFrame: Baseline, 12 mo.
measure: Change in sensory nerve action potential latency of sensory nerve conduction studies
timeFrame: Baseline, 12 mo.
measure: Change in peak-peak amplitude of the sensory nerve action potential of sensory nerve conduction studies
timeFrame: Baseline, 12 mo.
measure: Change in sensory discrimination
timeFrame: Baseline, 12 mo.
measure: Change in bowel function
timeFrame: Baseline, 12 mo.
measure: Change in bladder function
timeFrame: Baseline, 12 mo.
measure: Change in health-related quality of life
timeFrame: Baseline, 12 mo.
measure: Change in quality of life
timeFrame: Baseline, 12 mo.
measure: Change in pain
timeFrame: Baseline, 3 mo., 6 mo., 9 mo., 12 mo.
measure: Change in spasticity
timeFrame: Baseline, 12 mo.
Other outcomes:
Locations:
city: Viborg
country: Denmark
facility: Helge Kasch
state: Midtjylland
Study officials:
affiliation: Spinal Cord Injury Centre of Western Denmark
name: Helge Kasch, MD
role: STUDY_DIRECTOR
References: