Electrical Epidural Stimulation to Restore Hemodynamic Stability and Trunk Control in Individuals with Spinal Cord Injury
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
Spinal Cord Injury
(BASEC)
• Spinal cord injury between C3 and T6 (inclusive) • Spinal cord injury ≥ 1 month • Confirmed orthostatic hypotension (BASEC)
Ausschlusskriterien
• 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)
Studienstandort
Lausanne
(BASEC)
Sponsor
EPFL
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. G. Courtine
+41 21 69 30762
gregoire.courtine@clutterepfl.chEPFL
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
29.11.2021
(BASEC)
ICTRP Studien-ID
NCT05111093 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Epidural Electrical Stimulation to restore hemodynamic stability and trunk control in people with spinal cord injury (BASEC)
Wissenschaftlicher Titel
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury (ICTRP)
Öffentlicher Titel
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury (ICTRP)
Untersuchte Krankheit(en)
Spinal Cord Injuries (ICTRP)
Untersuchte Intervention
Device: ARC-IM Investigational System implantation (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Jocelyne Bloch, MD;Gregoire Courtine, Prof;Jocelyne Dr Bloch, Prof. Dr., gregoire.courtine@epfl.ch, +41 21 69 30762;, CHUV, (ICTRP)
Sekundäre IDs
HemON (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT05111093 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar