Deep Brain Stimulation Clinical Trial
— HoT-DBSOfficial title:
Deep Brain Stimulation of the Lateral Hypothalamus to Augment Motor Function of Patients With Spinal Cord Injury
NCT number | NCT04965727 |
Other study ID # | HoT-DBS2021 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 14, 2021 |
Est. completion date | January 2026 |
The purpose of this study is to evaluate safety of Deep Brain Stimulation (DBS) of the lateral hypothalamus (LH) and whether the use of DBS can increase motor performance in patients with chronic spinal cord injury (SCI). The hypothesis, based on preclinical findings, is that DBS of the lateral hypothalamus can acutely augment leg motor function after SCI, and that the use of lateral hypothalamus DBS can be an adjunct during rehabilitation to promote recovery and long-term neuroplasticity.
Status | Recruiting |
Enrollment | 3 |
Est. completion date | January 2026 |
Est. primary completion date | January 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | CHUV | Lausanne | Vaud |
Lead Sponsor | Collaborator |
---|---|
Jocelyne Bloch | Ecole Polytechnique Fédérale de Lausanne |
Switzerland,
Angeli CA, Boakye M, Morton RA, Vogt J, Benton K, Chen Y, Ferreira CK, Harkema SJ. Recovery of Over-Ground Walking after Chronic Motor Complete Spinal Cord Injury. N Engl J Med. 2018 Sep 27;379(13):1244-1250. doi: 10.1056/NEJMoa1803588. Epub 2018 Sep 24. — View Citation
Cortes M, Medeiros AH, Gandhi A, Lee P, Krebs HI, Thickbroom G, Edwards D. Improved grasp function with transcranial direct current stimulation in chronic spinal cord injury. NeuroRehabilitation. 2017;41(1):51-59. doi: 10.3233/NRE-171456. — View Citation
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van den Brand R, Heutschi J, Barraud Q, DiGiovanna J, Bartholdi K, Huerlimann M, Friedli L, Vollenweider I, Moraud EM, Duis S, Dominici N, Micera S, Musienko P, Courtine G. Restoring voluntary control of locomotion after paralyzing spinal cord injury. Science. 2012 Jun 1;336(6085):1182-5. doi: 10.1126/science.1217416. — View Citation
Wagner FB, Mignardot JB, Le Goff-Mignardot CG, Demesmaeker R, Komi S, Capogrosso M, Rowald A, Seanez I, Caban M, Pirondini E, Vat M, McCracken LA, Heimgartner R, Fodor I, Watrin A, Seguin P, Paoles E, Van Den Keybus K, Eberle G, Schurch B, Pralong E, Becce F, Prior J, Buse N, Buschman R, Neufeld E, Kuster N, Carda S, von Zitzewitz J, Delattre V, Denison T, Lambert H, Minassian K, Bloch J, Courtine G. Targeted neurotechnology restores walking in humans with spinal cord injury. Nature. 2018 Nov;563(7729):65-71. doi: 10.1038/s41586-018-0649-2. Epub 2018 Oct 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Evaluate the safety of the approach in terms of tolerability of deep brain stimulation of the lateral hypothalamus in patients with chronic spinal cord injury (> 1 year) | Through study completion, an average of 6 months | |
Secondary | Lower Extremity Motor Strength (M0-M5 score according to the AIS scale) | The American Spinal Injury Association (ASIA) Standard Neurological CLassification of Spinal Cord Injury is a standard method of assessing the neuological status, including motor and sensory evaluations, of a person who has sustained a spinal cord injury | Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation | |
Secondary | Walking Index for Spinal Cord Injury (WISCI II) | The WISCI II is an ordinal scale to assess walking function | Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation | |
Secondary | Walking speed (10MWT/6MWT) | 10 meter walk test (10MWT) and 6 minutes walk test (6MWT) are common tests used to measure walking speed and lomotor performance | Baseline ; pre-rehabilitation (2-3 weeks after surgery) ; after 1 month of rehabilitation ; after 3 months of rehabilitation |
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