Electrical Epidural Stimulation to Restore Hemodynamic Stability and Trunk Control in Individuals with Spinal Cord Injury
Résumé de l'étude
This study aims to demonstrate the efficacy and safety of a new therapy called "ARC-IM Therapy", which aims to electrically stimulate the spinal cord circuits directly responsible for regulating blood pressure, trunk stability, and spasticity in patients with spinal cord injury. This therapy aims to improve these functions in patients with a subacute or chronic injury located between C3 and T6 (inclusive) who suffer from orthostatic hypotension. It is also expected that this therapy will have a positive impact on the respiratory function of these patients or on their overall quality of life. The safety and efficacy of the experimental system (composed of electrodes and an implantable stimulator as well as applications to control the stimulation), associated procedures, and thus the therapy will be evaluated through this study to envision their integration into standard clinical rehabilitation programs.
(BASEC)
Intervention étudiée
Implantation of an electrical stimulation system of the spinal cord composed of an epidural electrode at the thoracic level and a stimulator at the right or left lateral abdomen.
(BASEC)
Maladie en cours d'investigation
Spinal Cord Injury
(BASEC)
• Spinal cord injury between C3 and T6 (inclusive) • Spinal cord injury ≥ 1 month • Confirmed orthostatic hypotension (BASEC)
Critères d'exclusion
• Spinal cord injury related to a neurodegenerative disease • Non-vesicular and vesicular injections of botulinum toxin performed in the last 3 months prior to inclusion • Presence of significant pressure ulcers (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
EPFL
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. G. Courtine
+41 21 69 30762
gregoire.courtine@clutterepfl.chEPFL
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
29.11.2021
(BASEC)
Identifiant de l'essai ICTRP
NCT05111093 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Epidural Electrical Stimulation to restore hemodynamic stability and trunk control in people with spinal cord injury (BASEC)
Titre académique
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury (ICTRP)
Titre public
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury (ICTRP)
Maladie en cours d'investigation
Spinal Cord Injuries (ICTRP)
Intervention étudiée
Device: ARC-IM Investigational System implantation (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
- 18 years of age or older
- Must provide and sign the Informed Consent prior to any study related procedures
- Spinal cord injury lesion level between C3 and T6 (inclusive)
- SCI = 1month
- Confirmed orthostatic hypotension
- Stable medical, physical and psychological condition as considered by the
investigators
- Able to understand and interact with the study team in French or English
- Agrees to comply in good faith with all conditions of the study and to attend all
scheduled appointments
Exclusion Criteria:
- SCI related to a neurodegenerative disease
- Diseases and conditions that would increase the morbidity and mortality of spinal
cord injury surgery
- The inability to withhold antiplatelet/anticoagulation agents perioperatively
- History of myocardial infarction or cerebrovascular event within the past 6 months
- Other conditions that would make the subject unable to participate in testing in the
judgement of the investigators
- Clinically significant mental illness in the judgement of the investigators
- Botulinum toxin vesical and non-vesical injections in the previous 3 months before
the enrolment
- Presence of significant pressure ulcers
- Recurrent urinary tract infection refractory to antibiotics
- Presence of indwelling baclofen or insulin pump
- Women who are pregnant (pregnancy test obligatory for woman of childbearing
potential) or breast feeding,
- Lack of safe contraception for women of childbearing capacity,
- Intention to become pregnant during the course of the study,
- Other clinically significant concomitant disease states (e.g., renal failure,
hepatic dysfunction, cardiovascular disease, etc.),
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders or dementia of the participant,
- Participation in another study with investigational drug within the 30 days
preceding and during the present study,
- Enrolment of the investigator, his/her family members, employees, and other
dependent persons. (ICTRP)
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Critères d'évaluation principaux et secondaires
Occurrence of Serious Adverse Events and Adverse Events that are deemed related or possibly related to the study procedure or to the ARC-IM Investigational System (ICTRP)
Orthostatic head-up tilt test (hemodynamic stability assessment);Modified Ashworth Scale (MAS) (spasticity assessment);SCIM III (daily life performance assessment) (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Jocelyne Bloch, MD;Gregoire Courtine, Prof;Jocelyne Dr Bloch, Prof. Dr., gregoire.courtine@epfl.ch, +41 21 69 30762;, CHUV, (ICTRP)
ID secondaires
HemON (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT05111093 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible