HumRes55288
|
SNCTP000004409
|
BASEC2020-01814
|
NCT04632290
Brain-controlled spinal cord stimulation in patients with spinal cord injury.
Zusammenfassung der Studie
This protocol aims to study the safety and preliminary efficacy of a brain-controlled spinal cord stimulation device in paraplegic patients. It targets patients who have previously experienced spinal cord stimulation for motor improvement during the STIMO protocol (SNCTP000001953: "Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury (STIMO)").
(BASEC)
Untersuchte Intervention
Brain-controlled electrical stimulation of the spinal cord
(BASEC)
Untersuchte Krankheit(en)
Spinal cord injury
(BASEC)
Kriterien zur Teilnahme
- Completed the main phase of the STIMO study: SNCTP000001953: "Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury - Provide informed consent - Aged between 18 and 65 years - Have a spinal cord injury (AIS A, B, C, or D) - The level of injury must be T10 or above based on the assessment of the Principal Investigator, with preservation of the conus - At least 60mm between the conus and the injury - Focal spinal cord injury of traumatic or hemorrhagic origin - At least 12 months post-injury - Completed a rehabilitation program - Have a stable medical, physical, and psychological condition according to the investigators - Be able to understand and communicate with the study team in French or English - Have adequate moral and material support and access to care - Agree in good faith to comply with the study instructions and attend the various appointments. (BASEC)
Ausschlusskriterien
- Pregnant or breastfeeding - Intention to conceive during the study - Lack of adequate contraception - Suffering from a severe illness outside of paralysis (e.g.: renal impairment, liver dysfunction, cardiovascular disease) - Documented or suspected substance or alcohol abuse - Inability to follow instructions due to language or psychological issues - Participation in another study involving a pharmaceutical product in the 30 days prior - Previous participation in this same study - Kinship, contractual, or dependency relationship with the investigator - Limitation of motor functions due to neurological diseases other than spinal cord injury (systemic diseases, cardiovascular disease limiting physical exercise, peripheral nervous system dysfunctions) - Severe dysreflexia - Cognitive or brain impairment - Epilepsy - Spinal canal stenosis - Use of a Baclofen pump - Cardiac implant such as pacemaker or defibrillator - Condition requiring the use of diathermy - Condition requiring the use of MRI - Increased risk of defibrillation - Severe contractures restricting leg movements - Hematological conditions with increased likelihood of surgery - Participation in another locomotion study - Congenital or acquired anomalies of the lower limbs - Neurodegenerative or cancerous spinal cord injury - Any other condition that may limit the participant's ability to follow the study in its entirety - Risk of death within the next 12 months. (BASEC)
- Completed the main phase of the STIMO study: SNCTP000001953: "Efficacy of Spinal Epidural Electrical Stimulation (EES) in Combination With Robot-assisted Neurorehabilitation in Patients With Spinal Cord Injury - Provide informed consent - Aged between 18 and 65 years - Have a spinal cord injury (AIS A, B, C, or D) - The level of injury must be T10 or above based on the assessment of the Principal Investigator, with preservation of the conus - At least 60mm between the conus and the injury - Focal spinal cord injury of traumatic or hemorrhagic origin - At least 12 months post-injury - Completed a rehabilitation program - Have a stable medical, physical, and psychological condition according to the investigators - Be able to understand and communicate with the study team in French or English - Have adequate moral and material support and access to care - Agree in good faith to comply with the study instructions and attend the various appointments. (BASEC)
Ausschlusskriterien
- Pregnant or breastfeeding - Intention to conceive during the study - Lack of adequate contraception - Suffering from a severe illness outside of paralysis (e.g.: renal impairment, liver dysfunction, cardiovascular disease) - Documented or suspected substance or alcohol abuse - Inability to follow instructions due to language or psychological issues - Participation in another study involving a pharmaceutical product in the 30 days prior - Previous participation in this same study - Kinship, contractual, or dependency relationship with the investigator - Limitation of motor functions due to neurological diseases other than spinal cord injury (systemic diseases, cardiovascular disease limiting physical exercise, peripheral nervous system dysfunctions) - Severe dysreflexia - Cognitive or brain impairment - Epilepsy - Spinal canal stenosis - Use of a Baclofen pump - Cardiac implant such as pacemaker or defibrillator - Condition requiring the use of diathermy - Condition requiring the use of MRI - Increased risk of defibrillation - Severe contractures restricting leg movements - Hematological conditions with increased likelihood of surgery - Participation in another locomotion study - Congenital or acquired anomalies of the lower limbs - Neurodegenerative or cancerous spinal cord injury - Any other condition that may limit the participant's ability to follow the study in its entirety - Risk of death within the next 12 months. (BASEC)
Studienstandort
Lausanne
(BASEC)
Switzerland (ICTRP)
Sponsor
EPFL
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Allgemeine Auskünfte
Centre Hospitalier Universitaire Vaudois
(ICTRP)
Wissenschaftliche Auskünfte
Centre Hospitalier Universitaire Vaudois
(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
30.10.2020
(BASEC)
ICTRP Studien-ID
NCT04632290 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury (STIMO-BSI) (BASEC)
Wissenschaftlicher Titel
Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury (ICTRP)
Öffentlicher Titel
Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury (ICTRP)
Untersuchte Krankheit(en)
Spinal Cord Injuries (ICTRP)
Untersuchte Intervention
Device: STIMO-BSI system implantationDevice: ARC-BSI Lumbar System (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:
- Having completed the main phase of the STIMO study (NCT02936453).
- SCI graded as American Spinal Injury Association Impairment Scale (AIS) A, B, C & D
- Level of lesion: T10 and above, based on AIS level determination by the PI, with
preservation of conus function
- The intact distance between the cone and the lesion must be at least 60 mm.
- Focal spinal cord disorder caused by either trauma or epidural, subdural or
intramedullary bleeding
- Minimum 12 months post-injury
- Completed in-patient rehabilitation program
- Stable medical, physical and psychological condition as considered by Investigators
- Able to understand and interact with the study team in French or English
- Adequate care-giver support and access to appropriate medical care in patient's home
community
- Must agree to comply in good faith with all conditions of the study and to attend
all required study training and visit
- Must provide and sign the Informed Consent prior to any study related procedures
Exclusion Criteria:
- Limitation of walking function based on accompanying (CNS) disorders (systemic
malignant disorders, cardiovascular disorders restricting physical training,
peripheral nerve disorders)
- History of severe autonomic dysreflexia
- Brain damage
- Epilepsy
- Spinal stenosis
- Use of an intrathecal Baclofen pump.
- Any active implanted cardiac device such as pacemaker or defibrillator.
- Any indication that would require diathermy.
- Any indication that would require MRI.
- Increased risk for defibrillation.
- Severe joint contractures disabling or restricting lower limb movements.
- Haematological disorders with increased risk for surgical interventions (increased
risk of haemorrhagic events).
- Congenital or acquired lower limb abnormalities (affection of joints and bone).
- Women who are pregnant (pregnancy test obligatory for women of childbearing
potential) or breast feeding or not willing to take contraception.
- Known or suspected non-compliance, drug or alcohol abuse.
- Spinal cord lesion due to either a neurodegenerative disease or a tumor.
- Gastrointestinal ulcers in the last five years
- Known or suspected eye disorders or diseases
- Other clinically significant concomitant disease states (e.g., renal failure,
hepatic dysfunction, cardiovascular disease, etc.)
- Any other anatomic or co-morbid conditions that, in the investigator's opinion,
could limit the patient's ability to participate in the study or to comply with
follow-up requirements, or impact the scientific soundness of the study results (ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
Safety Measure;Safety Measure (ICTRP)
WISCI II score;10mWT;Weight bearing capacity;SCIM III score;6minWT;Time Up and Go;Maximum Voluntary Contraction;ASIA score;Modified Ashworth Scale;Berg Balance Scale;Gait Analysis;WHOQOL-BREF;BCI performance measures;Upper Limb Neurobiomechanics;ECoG signal stability;SSEP (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois (ICTRP)
Sekundäre IDs
STIMO-BSI (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04632290 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar