Using deep brain stimulation to improve movement in spinal cord injury patients
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury
NA · Centre Hospitalier Universitaire Vaudois · NCT04965727
This study is testing if deep brain stimulation can help improve leg movement in people with chronic spinal cord injuries.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois (other) |
| Locations | 1 site (Lausanne, Vaud) |
| Trial ID | NCT04965727 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and potential effectiveness of deep brain stimulation (DBS) of the lateral hypothalamus in enhancing leg motor function in individuals with chronic spinal cord injury (SCI). The approach is based on preclinical findings suggesting that DBS can augment motor performance and promote neuroplasticity during rehabilitation. The study involves a series of phases including screening, surgery, calibration, and rehabilitation, with assessments conducted at various intervals to measure outcomes. The goal is to establish a foundation for larger clinical trials exploring the synergy between DBS and other rehabilitation techniques.
Who should consider this trial
Good fit: Ideal candidates are individuals with incomplete spinal cord injuries who can walk short distances with assistance and have been stable for at least 12 months post-injury.
Not a fit: Patients with significant accompanying central nervous system disorders or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve motor function and quality of life for patients with spinal cord injuries.
How similar studies have performed: While deep brain stimulation has been successfully used in other conditions, this specific application for spinal cord injury is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lausanne, Vaud
- CHUV — Lausanne, Vaud, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Jocelyne Bloch, MD — CHUV
- Study coordinator: Jocelyne Bloch, MD
- Email: jocelyne.bloch@chuv.ch
- Phone: 41795562951
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Deep Brain Stimulation, Neuro: Spinal Cord Injury, SCI, DBS, Spinal Cord Injury