Motor, Sensory, and Autonomic Function in Traumatic Spinal Cord Injury After the LION Procedure.
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

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.
    

Intervention name(s): LION procedure; NMES
Intervention type(s): Device; Device
Intervention description(s): Laparoscopic implantation of an impulse generator and four leads for electrical stimulation of femoral and sciatic nerves.; Conventional neuromuscular electrical stimulation via surface electrodes.
Other intervention name(s): Neurostimulation; Neuromuscular electrical stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment