Effect of pelvic laparoscopic implantation of neuroprosthesis in spinal cord injured subjects: a 1-year prospective randomized controlled study

Effect of pelvic laparoscopic implantation of neuroprosthesis in spinal cord injured subjects: a 1-year prospective randomized controlled study

Study design 1-year prospective RCT. Objective Examine the effect of implantable pulse generator and low-frequency stimulation of the pelvic nerves using laparoscopic implantation of neuroprosthesis (LION) compared with neuromuscular electrical stimulation (NMES) in SCI. Methods Inclusion criteria:...

Full description

Saved in:
Bibliographic Details
Published in:Spinal cord Vol. 60; no. 3; pp. 251 - 255
Main Authors: Kasch, Helge, Løve, Uffe Schou, Jønsson, Anette Bach, Severinsen, Kaare Eg, Possover, Marc, Elmgreen, Søren Bruno, Forman, Axel
Format: Journal Article
Language:English
Published: London Nature Publishing Group UK 01-03-2022
Nature Publishing Group
Subjects:
692/308/2779/777
692/617/375/1824
Adolescent
Adult
Age
Anatomy
Biomedical and Life Sciences
Biomedicine
Datasets
Electrical stimuli
Human Physiology
Humans
Implantation
Laparoscopy
Male
Males
Middle Aged
Nerves
Neural prostheses
Neurochemistry
Neuromuscular electrical stimulation
Neuropsychology
Neurosciences
Pain
Prospective Studies
Prosthetics
Pulse generators
Quality of Life
Spasticity
Spinal cord injuries
Spinal Cord Injuries - complications
Stimulation
Young Adult
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Study design 1-year prospective RCT. Objective Examine the effect of implantable pulse generator and low-frequency stimulation of the pelvic nerves using laparoscopic implantation of neuroprosthesis (LION) compared with neuromuscular electrical stimulation (NMES) in SCI. Methods Inclusion criteria: traumatic spinal cord injury (SCI), age 18–55 years, neurological level-of-injury Th4–L1, time-since-injury >1 year, and AIS-grades A–B. Participants were randomized to (A) LION procedure or (B) control group receiving NMES. Primary outcome measure: Walking Index for Spinal Cord Injury (WISCI-II), which is a SCI specific outcome measure assessing ability to ambulate. Secondary outcome measures: Spinal Cord Independence Measure III (SCIM III), Patient Global Impression of Change (PGIC), Penn Spasm Frequency Scale (PSFS), severity of spasticity measured by Numeric Rating Scale (NRS-11); International Spinal Cord Injury data sets-Quality of Life Basic Data Set (QoLBDS), and Brief Pain Inventory (BPI). Results Seventeen SCI individuals, AIS grade A, neurological level ranging from Th4–L1, were randomized to the study. One individual was excluded prior to intervention. Eight participants (7 males) with a mean age (SD) of 35.5 (12.4) years were allocated to the LION procedure, 8 participants (7 males) with age of 38.8 (15.1) years were allocated to NMES. Significantly, 5 LION group participants gained 1 point on the WISCI II scale, ( p  < 0.013; Fisher´s exact test). WISCI II scale score did not change in controls. No significant changes were observed in the secondary outcome measures. Conclusion The LION procedure is a promising new treatment for individuals with SCI with significant one-year improvement in walking ability.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ObjectType-Undefined-3
ISSN:1362-4393
1476-5624
DOI:10.1038/s41393-021-00693-7