Spinal Cord InjuriesSKYNCT02833428
Spinal Cord and Artificial Intelligence
A study testing Biomedical equipment (Eclipse Nim, Medtronic®) in people with Spinal Cord Injuries, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial summary
The aim of this study was to analyze using an artificial intelligence engine (IA) the influence of the pathophysiological environment (set parametric monitoring data, imaging, biology etc.) of acute spinal cord trauma on spinal pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Biomedical equipment (Eclipse Nim, Medtronic®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2018to 20 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with acute spinal cord injury between the cord opposite the vertebra C2 and marrow compared to the T12 vertebra.
- neurological lesion classified A, B, C or D according to Frankel classification at the initial examination (Annex 1).
- Patient able to give informed consent
Who cannot join
- There are no exclusion criteria. All patients meeting the inclusion criteria are includable. However, it differs remarkable different situations:
- The clinical neurological assessment of patients may be difficult depending on the context: intubated patients admitted - ventilated multiple trauma.
- Neurological assessment via evoked potentials may be difficult depending on the environment for patient care: need for multiple investigations, resuscitation. Evoked potentials will be installed only after agreement of the healthcare team once the patient is stabilized.
- The patient can refuse to submit to one additional exam is not part of the standard care (i.e. PES / PEM); it will be offered to participate in the study without the completion of this review. It will be in this case a simple use of clinical and laboratory data collected retrospectively anonymized so for scientific purposes.
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Paris Saint Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Acquisition and Analysis of Medullary Trauma Patients Signs, With an Expert Model
The aim of this study was to analyze using an artificial intelligence engine (IA) the influence of the pathophysiological environment (set parametric monitoring data, imaging, biology etc.) of acute spinal cord trauma on spinal pain. This project seeks to establish the principles of a new approach for studying spinal cord injury patients. It does not meet the usual criteria of clinical trials in so far as it does not test on patients the effect of a therapeutic
Read the detailed description
Objectives
The objectives are multiple:
- Analyze clinical situation in the pathophysiology of spinal pain.
- somatosensory evoked potentials analysis (PES) and motors (PEM) on injuries of the spinal cord in the acute phase.
- Increasing the mass of data integrated from current standards (volume). The reason is not only an imperative of statistical power as in a conventional test but the probability of specific events characterize this type of pathology and the consequences of their management (monitoring and therapeutic).
- Identify new predictive parameters and monitoring of spinal pain.
- Design the tools of computer collection, successful storage formats, adaptations of collection tools: This is validation of the technical solution (i.e. IA).
Expected results
This system will allow to record and analyze a large amount of parameters, largely beyond the human resources. Analysis of these data should allow better understanding of the pathophysiology of acute trauma of the spinal cord which is an essential prerequisite to research new therapies. The realization evoked potentials, ever conducted on this patient in the acute phase should also allow the investigators to better understand the mechanisms of evolution of the SCI (Spinal Cord Injury).
Moreover, this model expert system must allow, through the creation of routines, discovering new predictive parameters and monitoring, improving the management of these patients.
This is a completely open system that can be enriched with new parameters as and above all enriching also as and when the inclusion of new cases. It therefore offers a theoretical field of infinite discovery extremely promising.
- Conditions
- Spinal Cord Injuries
- Being tested
- Biomedical equipment (Eclipse Nim, Medtronic®)
- 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.
Biomedical equipment (Eclipse Nim, Medtronic®)Device
It is the principal investigator (coordinator investigator moving on the website of the Pitié-Salpêtrière) that will install bedside biomedical equipment for the project (Eclipse Nim, Medtronic®) The term of monitoring will depend of length of stay in the PACU (the post anesthesia care unit) Gaston Cordier and will not exceed 72 hours.
- Patients will be reviewed at 6 and 12 months for conventional control with establishing a ASIA score (American Spinal Cord Injury Association). Of SEP (Somatosensory evoked potentials) and MEP(Motor Engine Potentials) will be performed in the laboratory at 6 and 12 months (electrophysiology laboratory Pitié-Salpêtrière). They are part of the traditional support in the context of spinal cord trauma.
| Study group | Role | What they receive |
|---|---|---|
| patients with acute spinal cord injury | Experimental | The study will be performed on patients with acute spinal cord injury between the cord next to the C2 vertebra and marrow next to the T12 vertebra. This is usually hospitalized patients in an emergency situation, brought by EMS (emergency medical services) and taken care of immediately in the recovery room by intensivists. Patients who accepted to participate to this study will got the installation bedside biomedical equipment for the project (Eclipse Nim, Medtronic®). The aim of this work is to analyze using an artificial intelligence engine (IA, Biomedical equipment (Eclipse Nim, Medtronic®)) the influence of the physiopathological environment (set of parametric data monitoring, imaging, biology etc.) of the traumatized spinal cord on spinal pain. Receives: Device: Biomedical equipment (Eclipse Nim, Medtronic®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of change of ASIA impairment scale (American Spinal Cord Injury Association)
ASIA impairment scale allows to classify the spinal cord injury according to its level of neurological damage. It is conventionally represented by the most caudal segment having a normal function.
It allows to appreciate the completeness or incompleteness of the attack. It allows a classification highlighting the severity of the attack by using a five-letter ASIA anomaly scale from A to E.
Measured: Day1, 6 months and 1 year
Secondary outcomes (2)
Assessment of change of Somatosensory Evoked Potentials (SEPs)
The principal investigator proceeds to the installation of the patient's biomedical material for the project (Nim Eclipse, Medtronic®). The duration of the monitoring will be function the duration of hospitalization in SSPI Gaston Cordier and will not exceed 72 hours. Each night during this period, a non-stimulation range of 6 hours will be provided to allow the included volunteers to sleep.
Measured: Day1, 6 months
Assessment of change of Motor Evoked Potentials (PEM)
The principal investigator proceeds to the installation of the patient's biomedical material for the project (Nim Eclipse, Medtronic®). The duration of the monitoring will be function the duration of hospitalization in SSPI Gaston Cordier and will not exceed 72 hours. Each night during this period, a non-stimulation range of 6 hours will be provided to allow the included volunteers to sleep.
Measured: Day1, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study start20 Jan 2018
- Primary completion20 Jan 2022
- Study completion20 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RIOUALLON Guillaume, MD, Principal investigator, Groupe Hospitalier Paris Saint-Joseph (FRANCE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02833428
- Sponsor's protocol ID
- SKY
- Acronym
- SKY
- Status last verified
- Mar 2023
- First submitted
- 12 Jul 2016
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition and Analysis of Medullary Trauma Patients Signs, With an Expert Model
- ClinicalTrials.gov ID
- NCT02833428
- Acronym / sponsor ID
- SKY / SKY
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 14 Jul 2016 (estimated)
- 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.
The aim of this study was to analyze using an artificial intelligence engine (IA) the influence of the pathophysiological environment (set parametric monitoring data, imaging, biology etc.) of acute spinal cord trauma on spinal pain. This project seeks to establish the principles of a new approach for studying spinal cord injury patients. It does not meet the usual criteria of clinical trials in so far as it does not test on patients the effect of a therapeutic
Detailed description
Objectives
The objectives are multiple:
- Analyze clinical situation in the pathophysiology of spinal pain.
- somatosensory evoked potentials analysis (PES) and motors (PEM) on injuries of the spinal cord in the acute phase.
- Increasing the mass of data integrated from current standards (volume). The reason is not only an imperative of statistical power as in a conventional test but the probability of specific events characterize this type of pathology and the consequences of their management (monitoring and therapeutic).
- Identify new predictive parameters and monitoring of spinal pain.
- Design the tools of computer collection, successful storage formats, adaptations of collection tools: This is validation of the technical solution (i.e. IA).
Expected results
This system will allow to record and analyze a large amount of parameters, largely beyond the human resources. Analysis of these data should allow better understanding of the pathophysiology of acute trauma of the spinal cord which is an essential prerequisite to research new therapies. The realization evoked potentials, ever conducted on this patient in the acute phase should also allow the investigators to better understand the mechanisms of evolution of the SCI (Spinal Cord Injury).
Moreover, this model expert system must allow, through the creation of routines, discovering new predictive parameters and monitoring, improving the management of these patients.
This is a completely open system that can be enriched with new parameters as and above all enriching also as and when the inclusion of new cases. It therefore offers a theoretical field of infinite discovery extremely promising.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute spinal cord injury | Experimental | Device: Biomedical equipment (Eclipse Nim, Medtronic®)The study will be performed on patients with acute spinal cord injury between the cord next to the C2 vertebra and marrow next to the T12 vertebra. This is usually hospitalized patients in an emergency situation, brought by EMS (emergency medical services) and taken care of immediately in the recovery room by intensivists. Patients who accepted to participate to this study will got the installation bedside biomedical equipment for the project (Eclipse Nim, Medtronic®). The aim of this work is to analyze using an artificial intelligence engine (IA, Biomedical equipment (Eclipse Nim, Medtronic®)) the influence of the physiopathological environment (set of parametric data monitoring, imaging, biology etc.) of the traumatized spinal cord on spinal pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with acute spinal cord injury between the cord opposite the vertebra C2 and marrow compared to the T12 vertebra.
- neurological lesion classified A, B, C or D according to Frankel classification at the initial examination (Annex 1).
- Patient able to give informed consent
Key exclusion criteria (4 listed)
- There are no exclusion criteria. All patients meeting the inclusion criteria are includable. However, it differs remarkable different situations:
- The clinical neurological assessment of patients may be difficult depending on the context: intubated patients admitted - ventilated multiple trauma.
- Neurological assessment via evoked potentials may be difficult depending on the environment for patient care: need for multiple investigations, resuscitation. Evoked potentials will be installed only after agreement of the healthcare team once the patient is stabilized.
- The patient can refuse to submit to one additional exam is not part of the standard care (i.e. PES / PEM); it will be offered to participate in the study without the completion of this review. It will be in this case a simple use of clinical and laboratory data collected retrospectively anonymized so for scientific purposes.
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 |
|---|---|---|
| Biomedical equipment (Eclipse Nim, Medtronic®)It is the principal investigator (coordinator investigator moving on the website of the Pitié-Salpêtrière) that will install bedside biomedical equipment for the project (Eclipse Nim, Medtronic®) The term of monitoring will depend of length of stay in the PACU (the post anesthesia care unit) Gaston Cordier and will not exceed 72 hours. • Patients will be reviewed at 6 and 12 months for conventional control with establishing a ASIA score (American Spinal Cord Injury Association). Of SEP (Somatosensory evoked potentials) and MEP(Motor Engine Potentials) will be performed in the laboratory at 6 and 12 months (electrophysiology laboratory Pitié-Salpêtrière). They are part of the traditional support in the context of spinal cord trauma. | Device | patients with acute spinal cord injury |
Primary outcome
Assessment of change of ASIA impairment scale (American Spinal Cord Injury Association)
Time frame: Day1, 6 months and 1 year
ASIA impairment scale allows to classify the spinal cord injury according to its level of neurological damage. It is conventionally represented by the most caudal segment having a normal function. It allows to appreciate the completeness or incompleteness of the attack. It allows a classification highlighting the severity of the attack by using a five-letter ASIA anomaly scale from A to E.
2 secondary outcomes
Assessment of change of Somatosensory Evoked Potentials (SEPs)
Time frame: Day1, 6 months
Assessment of change of Motor Evoked Potentials (PEM)
Time frame: Day1, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
RIOUALLON Guillaume, MD principal investigator
Groupe Hospitalier Paris Saint-Joseph (FRANCE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biomedical equipment (Eclipse Nim, Medtronic®) in people with Spinal Cord Injuries, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Mar 2023. 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 France. 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?
Results are not available in the source record.
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?
Assessment of change of ASIA impairment scale (American Spinal Cord Injury Association) (time frame: Day1, 6 months and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2023.