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

NCT03441256 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-09-28

No results posted yet for this study

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

Interventions

DEVICE

LION procedure

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

DEVICE

NMES

Conventional neuromuscular electrical stimulation via surface electrodes.

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Regionshospitalet Viborg, Skive

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Spinal Cord Injury Centre of Western Denmark

    lead OTHER

Principal Investigators

  • Helge Kasch, MD · Spinal Cord Injury Centre of Western Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03441256 on ClinicalTrials.gov