Brief description of trial (Data source: BASEC)
Cette étude est un essai clinique de faisabilité d'une nouvelle thérapie utilisant un dispositif de stimulation cérébrale profonde, utilisé hors de son indication initiale. Elle doit se dérouler au Centre Hospitalier Universitaire Vaudois (CHUV) de Lausanne, en Suisse.
Cette étude vise, d'une part, à évaluer la sécurité de cette thérapie chez des participants souffrant de lésion de la moelle épinière, et d'autre part, à évaluer son efficacité quant à l'amélioration des capacités motrices chez ces mêmes participants.
Il est prévu d'inclure trois participants souffrant de lésion de la moelle épinière depuis au moins 12 mois.
Ces participants se verront implanter 2 électrodes dans le cerveau ainsi qu'un générateur d'impulsion électrique qui sera placé sous la peau, au niveau de la poitrine.
La durée de cet essai est de 12 mois et la participation de chaque participant doit durer 6 mois. Pendant cette période, chaque participant devra prendre part à une phase de rééducation de 3 mois, à la suite de la chirurgie, durant laquelle le système de stimulation cérébrale implanté sera mis en marche par le personnel de l'étude lors de séances de rééducation afin d'en évaluer l'impact sur les capacités motrices du participant.
A la suite de cette phase de rééducation, les participants pourront retourner chez eux pour une période de 3 mois, durant laquelle le système de stimulation cérébrale ne sera pas mis en marche.
Divers évaluations et tests (performance de marche, enregistrements neurobiomécaniques, imagerie) seront effectués tout au long de l'étude pour juger de l'amélioration ou non des fonctions motrices des participants grâce à l'utilisation de la stimulation cérébrale profonde.
Health conditions investigated(Data source: BASEC)
Lesion de la moelle épinière
Health conditions
(Data source: WHO)
Deep Brain Stimulation;Neuro: Spinal Cord Injury
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Implantation d'un système de stimulation cérébrale profonde composé de deux électrodes cérébrales (dans les parties droite et gauche du cerveau) reliées à un générateur d'impulsion électrique (sous la peau, au niveau de la poitrine)
Interventions
(Data source: WHO)
Procedure: Device implantation
Criteria for participation in trial
(Data source: BASEC)
- Age 18-65 ans (Hommes ou femmes)
- Lésion incomplète de la moelle épinière (participant capable de marcher de manière autonome sur quelques mètres avec un déambulateur)
- Lésion de la moelle épinière d’une ancienneté supérieure à 12 mois.
Exclusion criteria
(Data source: BASEC)
- Femmes enceintes ou allaitantes (test de grossesse obligatoire)
- Lésion de la moelle épinière due à des troubles dégénératifs, de la circulation sanguine ou tumoraux
- Limitation de la fonction locomotrice due à : des troubles systémiques graves, des troubles cardio-vasculaires limitant l'entraînement physique, des troubles des nerfs périphériques.
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: 65 Years
Minimum age: 18 Years
Inclusion Criteria:
- SCI graded as American Spinal Injury Association Impairment Scale (AIS) C or D (able
to walk independently for a few meters with a walker)
- Focal spinal cord disorder caused by trauma
- Minimum 12 months post-injury
- 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 Informed Consent prior to any study related procedures
Exclusion Criteria:
- Limitation of walking function based on accompanying (CNS) disorders (i.e., systemic
malignant disorders, cardiovascular disorders restricting physical training,
peripheral nerve disorders)
- History of significant autonomic dysreflexia
- Cognitive/brain damage
- Epilepsy
- Use of an intrathecal baclofen pump
- Any active implanted cardiac device such as pacemaker or defibrillator
- Any indication that would require diathermy
- Increased risk for defibrillation
- Severe joint contractures disabling or restricting lower limb movements
- Hematological disorders with increased risk for surgical interventions
- Congenital or acquired lower limb abnormalities (affection of joints and bone)
- Women who are pregnant (pregnancy test obligatory for woman of childbearing potential)
or breastfeeding
- Lack of safe contraception for women of childbearing capacity
- 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
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. 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
- Participation in another locomotor training study
- Refusal to be informed of any finding during the study
-
Further information on trial
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
Occurence of all SAEs and AEs that are deemed related or possibly related to study procedure or to study investigational system, from implantation up to the end of the study
Secundary end point
(Data source: WHO)
Lower Extremity Motor Strength (M0-M5 score according to the AIS scale);Walking Index for Spinal Cord Injury (WISCI II);Walking speed (10MWT/6MWT)
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Lausanne
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Jocelyne Bloch
+41 79 556 2951
jocelyne.bloch@chuv.ch
Contact for general information
(Data source: WHO)
Jocelyne Bloch, MD
CHUV
41795562951;0041795562951
jocelyne.bloch@chuv.ch
Contact for scientific information
(Data source: WHO)
Jocelyne Bloch, MD
CHUV
41795562951;0041795562951
jocelyne.bloch@chuv.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Commission
cantonale d’Éthique de la Recherche sur l’être humain Vaud (CER-VD)
Date of authorisation by the ethics committee
08.04.2021
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2021-00095
Secondary ID (Data source: WHO)
HoT-DBS2021
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