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

NCT03441256 | Completed DMC

• 1 other identifier: VCR-SBE-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Improvement/change in walking capacity

  Walking index for spinal cord injury, second revision (WISCI II)

  Baseline, 3 mo., 6 mo., 9 mo., 12 mo.

Secondary Outcomes (15)

• Change in lean body mass

  Baseline, 12 mo.

• Change in distal motor latency of motor nerve conduction studies

  Baseline, 12 mo.

• Change in peak-peak amplitude of motor nerve conduction studies

  Baseline, 12 mo.

• Change in muscle microarchitecture

  Baseline, 12 mo.

• Change in muscle motor unit number

  Baseline, 12 mo.

Study Arms (2)

Intervention

EXPERIMENTAL

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

Device: LION procedure

Control

ACTIVE COMPARATOR

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

Device: NMES

Interventions

LION procedure DEVICE

Laparoscopic implantation of an impulse generator and four leads for electrical stimulation of femoral and sciatic nerves.

Also known as: Neurostimulation

Intervention

NMES DEVICE

Conventional neuromuscular electrical stimulation via surface electrodes.

Also known as: Neuromuscular electrical stimulation

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Willing and able to give informed consent for participation in the clinical investigation, and to comply with all requirements of the clinical investigation
• 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

You may not qualify if:

• Female subject who is pregnant/planning pregnancy during the clinical investigation.
• Previous surgery/procedures interfering with the LION procedure incl. the presence of other implanted medical devices.
• 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

Sponsors & Collaborators

• Spinal Cord Injury Centre of Western Denmark: lead
• Aarhus University Hospital: collaborator
• Regionshospitalet Viborg, Skive: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Helge Kasch

Viborg, Central Jutland, 8800, Denmark

Location

Related Publications (1)

• Possover M, Abrao HM. Low-frequency antidromic pelvic neuromodulation as a potential enhancer of recovery after spinal cord injury: hypothetical promotion of spinal Renshaw cells and corticovagal plasticity. J Spinal Cord Med. 2025 Sep 15:1-7. doi: 10.1080/10790268.2024.2414146. Online ahead of print.

  PMID: 40952735 DERIVED

Related Links

• Effect of pelvic laparoscopic implantation of neuroprosthesis in spinal cord injured subjects: a 1-year prospective randomized controlled study
• Surgical Aspects of the Possover LION Procedure: An Emerging Procedure for Recovery of Visceral Functions and Locomotion in Paraplegics

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Helge Kasch, MD

  Spinal Cord Injury Centre of Western Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 22, 2018
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)