Spinal Cord InjuriesSCI-LIONNCT03441256
Motor, Sensory, and Autonomic Function in Traumatic Spinal Cord Injury After the LION Procedure.
A study testing LION procedure and NMES in people with Spinal Cord Injuries, run by Spinal Cord Injury Centre of Western Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- LION procedure and NMES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Motor, Sensory, and Autonomic Function After Laparoscopic Implantation of Neuroprosthesis - a Randomized Controlled Trial of the LION Procedure in Traumatic Spinal Cord Injury
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.
Read the detailed 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- LION procedure, NMES
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LION procedureDevice
Also called Neurostimulation
Laparoscopic implantation of an impulse generator and four leads for electrical stimulation of femoral and sciatic nerves.
NMESDevice
Also called Neuromuscular electrical stimulation
Conventional neuromuscular electrical stimulation via surface electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participant in the intervention group will undergo the LION procedure and subsequent neurostimulation. Receives: Device: LION procedure |
| Control | Active comparator | All participants in the control group will be issued with a device for neuromuscular electrical stimulation. Receives: Device: NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement/change in walking capacity
Walking index for spinal cord injury, second revision (WISCI II)
Measured: Baseline, 3 mo., 6 mo., 9 mo., 12 mo.
Secondary outcomes (15)
Change in lean body mass
Changes in lean body mass on dual-energy x-ray absorptiometry
Measured: Baseline, 12 mo.
Change in distal motor latency of motor nerve conduction studies
Preoperative to postoperative change in distal motor latency of the compound muscle action potential.
Measured: Baseline, 12 mo.
Change in peak-peak amplitude of motor nerve conduction studies
Preoperative to postoperative change in change in peak to peak amplitude of the compound muscle action potential.
Measured: Baseline, 12 mo.
Change in muscle microarchitecture
Preoperative to postoperative changes in fiber-type composition on histochemical analysis of soles muscle biopsies.
Measured: Baseline, 12 mo.
Change in muscle motor unit number
Preoperative to postoperative changes in motor unit number estimation.
Measured: Baseline, 12 mo.
Change in compound muscle action potential scans.
Preoperative to postoperative changes in compound muscle action potential scan slope.
Measured: Baseline, 12 mo.
Change in sensory nerve action potential latency of sensory nerve conduction studies
Preoperative to postoperative change in sensory nerve action potential latency.
Measured: Baseline, 12 mo.
Change in peak-peak amplitude of the sensory nerve action potential of sensory nerve conduction studies
Preoperative to postoperative change in peak-peak amplitude of the sensory nerve action potential.
Measured: Baseline, 12 mo.
Change in sensory discrimination
Change in parameters of quantitative sensory testing applying method of limits.
Measured: Baseline, 12 mo.
Change in bowel function
Changes in scores on the international spinal cord injury data set - bowel function
Measured: Baseline, 12 mo.
Change in bladder function
Changes in scores on the international spinal cord injury data set - lower urinary tract function
Measured: Baseline, 12 mo.
Change in health-related quality of life
Changes in scores of the international spinal cord injury data set - quality of life
Measured: Baseline, 12 mo.
Change in quality of life
Changes in the scores of the Short Form 36 questionnaire; the questionnaire has eight subscales (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health). Each sub scale scores 0-100, 0 indicating maximal disability.
Measured: Baseline, 12 mo.
Change in pain
Changes in the brief pain inventory questionnaire; questionnaire consists of 17-items addressing pain severity, pain location, pain chronicity, and amount of pain relief. Each item scores are 0-10, 10 indicating either maximum pain severity, maximum interference or maximum relief, respectively.
Measured: Baseline, 3 mo., 6 mo., 9 mo., 12 mo.
Change in spasticity
Changes in scores of the modified Tardieu Scale for spasticity; scores 0-4, 4 being maximum level of spasticity.
Measured: Baseline, 12 mo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spinal Cord Injury Centre of Western Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Viborg, Skive, University of Southern Denmark
- Responsible party
- Sponsor
- Investigators
- Helge Kasch, MD, Study director, Spinal Cord Injury Centre of Western Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441256
- Sponsor's protocol ID
- VCR-SBE-01
- Acronym
- SCI-LION
- Status last verified
- Mar 2021
- First submitted
- 24 Jan 2018
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data may be requested by other researchers. Approvals from the Danish Data Protection Agency and individual participants will be required before data may be shared.
Publications
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. 2026 Mar;49(2):388-394. doi: 10.1080/10790268.2024.2414146. Epub 2025 Sep 15.
PubMed 40952735
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor, Sensory, and Autonomic Function After Laparoscopic Implantation of Neuroprosthesis - a Randomized Controlled Trial of the LION Procedure in Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03441256
- Acronym / sponsor ID
- SCI-LION / VCR-SBE-01
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Spinal Cord Injury Centre of Western DenmarkUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Regionshospitalet Viborg, Skive, University of Southern Denmark
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: LION procedureAll participant in the intervention group will undergo the LION procedure and subsequent neurostimulation. |
| Control | Active comparator | Device: NMESAll participants in the control group will be issued with a device for neuromuscular electrical stimulation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LION procedureAlso: NeurostimulationLaparoscopic implantation of an impulse generator and four leads for electrical stimulation of femoral and sciatic nerves. | Device | Intervention |
| NMESAlso: Neuromuscular electrical stimulationConventional neuromuscular electrical stimulation via surface electrodes. | Device | Control |
Primary outcome
Improvement/change in walking capacity
Time frame: Baseline, 3 mo., 6 mo., 9 mo., 12 mo.
Walking index for spinal cord injury, second revision (WISCI II)
15 secondary outcomes
Change in lean body mass
Time frame: Baseline, 12 mo.
Change in distal motor latency of motor nerve conduction studies
Time frame: Baseline, 12 mo.
Change in peak-peak amplitude of motor nerve conduction studies
Time frame: Baseline, 12 mo.
Change in muscle microarchitecture
Time frame: Baseline, 12 mo.
Change in muscle motor unit number
Time frame: Baseline, 12 mo.
Change in compound muscle action potential scans.
Time frame: Baseline, 12 mo.
Change in sensory nerve action potential latency of sensory nerve conduction studies
Time frame: Baseline, 12 mo.
Change in peak-peak amplitude of the sensory nerve action potential of sensory nerve conduction studies
Time frame: Baseline, 12 mo.
Change in sensory discrimination
Time frame: Baseline, 12 mo.
Change in bowel function
Time frame: Baseline, 12 mo.
Change in bladder function
Time frame: Baseline, 12 mo.
Change in health-related quality of life
Time frame: Baseline, 12 mo.
Change in quality of life
Time frame: Baseline, 12 mo.
Change in pain
Time frame: Baseline, 3 mo., 6 mo., 9 mo., 12 mo.
Change in spasticity
Time frame: Baseline, 12 mo.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 40952735Possover 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. 2026 Mar;49(2):388-394. doi: 10.1080/10790268.2024.2414146. Epub 2025 Sep 15.
- Effect of pelvic laparoscopic implantation of neuroprosthesis in spinal cord injured subjects: a 1-year prospective randomized controlled studyLink provided by the sponsor.
- Surgical Aspects of the Possover LION Procedure: An Emerging Procedure for Recovery of Visceral Functions and Locomotion in ParaplegicsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data may be requested by other researchers. Approvals from the Danish Data Protection Agency and individual participants will be required before data may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helge Kasch, MD study director
Spinal Cord Injury Centre of Western Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LION procedure and NMES in people with Spinal Cord Injuries, run by Spinal Cord Injury Centre of Western Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement/change in walking capacity (time frame: Baseline, 3 mo., 6 mo., 9 mo., 12 mo.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03441256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.