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

Bidragets oversatte titel: Effekt af implantation af neuroprosthesis (LION) hos personer med rygmarvsskade. Et 1-årigt prospektivt randomiseret kontrolleret studie.

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Abstract

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.

Bidragets oversatte titelEffekt af implantation af neuroprosthesis (LION) hos personer med rygmarvsskade. Et 1-årigt prospektivt randomiseret kontrolleret studie.
OriginalsprogEngelsk
TidsskriftSpinal Cord
Vol/bind60
Nummer3
Sider (fra-til)251-255
Antal sider5
ISSN1362-4393
DOI
StatusUdgivet - mar. 2022

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