HumRes55288
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SNCTP000004409
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BASEC2020-01814
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NCT04632290
Brain-controlled spinal cord stimulation in patients with spinal cord injury.
Summary description of the study
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)
Intervention under investigation
Brain-controlled electrical stimulation of the spinal cord
(BASEC)
Disease under investigation
Spinal cord injury
(BASEC)
Criteria for participation in trial
- 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)
Exclusion criteria
- 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)
Exclusion criteria
- 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)
Trial sites
Lausanne
(BASEC)
Switzerland (ICTRP)
Sponsor
EPFL
(BASEC)
Contact
General Information
Centre Hospitalier Universitaire Vaudois
(ICTRP)
Scientific Information
Centre Hospitalier Universitaire Vaudois
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
30.10.2020
(BASEC)
ICTRP Trial ID
NCT04632290 (ICTRP)
Official title (approved by ethics committee)
Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury (STIMO-BSI) (BASEC)
Academic title
Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury (ICTRP)
Public title
Brain-controlled Spinal Cord Stimulation in Patients With Spinal Cord Injury (ICTRP)
Disease under investigation
Spinal Cord Injuries (ICTRP)
Intervention under investigation
Device: STIMO-BSI system implantationDevice: ARC-BSI Lumbar System (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Jocelyne Bloch, Centre Hospitalier Universitaire Vaudois (ICTRP)
Secondary trial IDs
STIMO-BSI (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT04632290 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available