Electrical Epidural Stimulation to Restore Hemodynamic Stability and Trunk Control in Individuals with Spinal Cord Injury

Switzerland (ICTRP)

ID di studio ICTRP
NCT05111093 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Epidural Electrical Stimulation to restore hemodynamic stability and trunk control in people with spinal cord injury (BASEC)

Titolo accademico
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury (ICTRP)

Titolo pubblico
Epidural Electrical Stimulation to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury (ICTRP)

Malattie studiate
Spinal Cord Injuries (ICTRP)

Intervento studiato
Device: ARC-IM Investigational System implantation (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
Jocelyne Bloch, MD;Gregoire Courtine, Prof;Jocelyne Dr Bloch, Prof. Dr., gregoire.courtine@epfl.ch, +41 21 69 30762;, CHUV, (ICTRP)

ID secondari
HemON (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT05111093 (ICTRP)