Motor, Sensory, and Autonomic Function in Traumatic Spinal Cord Injury After the LION Procedure. (SCI-LION)

Spinal Cord Injury Centre of Western Denmark

Status: Completed

Conditions: Spinal Cord Injuries

Treatments: Device: NMES; Device: LION procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03441256

VCR-SBE-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Intervention

Experimental group

Description:

All participant in the intervention group will undergo the LION procedure and subsequent neurostimulation.

Treatment:

Device: LION procedure

Control

Active Comparator group

Description:

All participants in the control group will be issued with a device for neuromuscular electrical stimulation.

Treatment:

Device: NMES