Deep brain stimulation of the lateral hypothalamus to enhance motor function in patients with spinal cord injury
Zusammenfassung der Studie
This study is a feasibility clinical trial of a new therapy using a deep brain stimulation device, used outside its original indication. It is to be conducted at the Centre Hospitalier Universitaire Vaudois (CHUV) in Lausanne, Switzerland. This study aims, on one hand, to evaluate the safety of this therapy in participants suffering from spinal cord injury, and on the other hand, to assess its efficacy in improving motor abilities in these same participants. It is planned to include three participants suffering from spinal cord injury for at least 12 months. These participants will have 2 electrodes implanted in the brain as well as an electrical pulse generator that will be placed under the skin, at the chest level. The duration of this trial is 12 months and the participation of each participant is to last 6 months. During this period, each participant will have to take part in a 3-month rehabilitation phase following the surgery, during which the implanted deep brain stimulation system will be activated by the study staff during rehabilitation sessions to evaluate its impact on the participant's motor abilities. Following this rehabilitation phase, participants will be able to return home for a period of 3 months, during which the deep brain stimulation system will not be activated. Various assessments and tests (walking performance, neurobiomechanical recordings, imaging) will be carried out throughout the study to judge the improvement or not of the motor functions of the participants due to the use of deep brain stimulation.
(BASEC)
Untersuchte Intervention
Implantation of a deep brain stimulation system consisting of two cerebral electrodes (in the right and left parts of the brain) connected to an electrical impulse generator (under the skin, at chest level)
(BASEC)
Untersuchte Krankheit(en)
Spinal cord injury
(BASEC)
- Age 18-65 (Men or women) - Incomplete spinal cord injury (participant able to walk a few meters independently with a walker) - Spinal cord injury more than 12 months old. (BASEC)
Ausschlusskriterien
- Pregnant or breastfeeding women (mandatory pregnancy test) - Spinal cord injury due to degenerative, blood circulation or tumor disorders - Limitation of locomotor function due to: serious systemic disorders, cardiovascular disorders limiting physical training, peripheral nerve disorders. (BASEC)
Studienstandort
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
08.04.2021
(BASEC)
ICTRP Studien-ID
NCT04965727 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Deep brain stimulation of the lateral hypothalamus to augment motor functions of patients with spinal cord injury (BASEC)
Wissenschaftlicher Titel
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury (ICTRP)
Öffentlicher Titel
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury (ICTRP)
Untersuchte Krankheit(en)
Deep Brain Stimulation;Neuro: Spinal Cord Injury (ICTRP)
Untersuchte Intervention
Procedure: Device implantation (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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
(ICTRP)
nicht verfügbar
Primäre und sekundäre Endpunkte
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 (ICTRP)
Lower Extremity Motor Strength (M0-M5 score according to the AIS scale);Walking Index for Spinal Cord Injury (WISCI II);Walking speed (10MWT/6MWT) (ICTRP)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
Ecole Polytechnique F?d?rale de Lausanne (ICTRP)
Weitere Kontakte
Jocelyne Bloch, MD;Jocelyne Bloch, MD;Jocelyne Bloch, MD, jocelyne.bloch@chuv.ch, 41795562951;0041795562951, CHUV, (ICTRP)
Sekundäre IDs
HoT-DBS2021 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT04965727 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar