Deep brain stimulation to improve walking in patients with incomplete spinal cord injury
A Phase I/II Open-label Multicenter Trial to Evaluate Safety and Preliminary Efficacy of Unilateral Deep Brain Stimulation of the Mesencephalic Locomotor Region in Patients With Incomplete Spinal Cord Injury
This study is testing if a new brain stimulation treatment can help people with incomplete spinal cord injuries walk better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT03053791 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and preliminary efficacy of unilateral deep brain stimulation (DBS) targeting the mesencephalic locomotor region in patients with incomplete spinal cord injuries. Participants, aged 18-75, who have completed in-patient rehabilitation and are at least three months post-injury, will undergo DBS implantation. The primary goal is to assess improvements in locomotion using the 6-Minute walking test, alongside secondary evaluations of quality of life and other health metrics over a six-month period. The study aims to explore a novel approach to enhance mobility in individuals who currently have limited treatment options.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-75 with motor incomplete spinal cord injuries who have completed rehabilitation and can walk with assistance.
Not a fit: Patients with complete spinal cord injuries or those who do not meet the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve mobility and quality of life for patients with incomplete spinal cord injuries.
How similar studies have performed: While deep brain stimulation has shown promise in other movement disorders, this specific application for incomplete spinal cord injury is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Informed Consent 2. Participation in two assessment sessions before enrollment (Screening and baseline) 3. Willingness and ability to comply with the protocol and to attend required study training and visits 4. Male or female subjects 5. Age 18-75 6. Motor incomplete SCI 7. Level of lesion: T10 and above, based on AIS level, preservation of sacral function 8. Focal spinal cord disorder caused by either trauma or non-traumatic and non-progressive condition (like hemorrhage, benign tumor) 9. Minimum 3 months of recovery after SCI, maximum 2 years after trauma 10. Completed in-patient rehabilitation program 11. WISCI II, level \>2 (0-20 items): assistance of one or more persons. Ability to walk at least 10 meters 12. Stable medical and physical condition. 13. Adequate care-giver support and access to appropriate medical care in patient's home community Exclusion Criteria: 1. Enrollment of the investigator, his/her family members, employees and other dependent persons 2. Limitation of standing and walking function based on accompanying (CNS) disorders 3. Cardiovascular disorders restricting physical training or peripheral nerve disorders 4. Implanted technical devices (pacemaker, defibrillator) 5. History of significant autonomic dysreflexia 6. Cognitive disorders/brain damage 7. Drug refractory epilepsy 8. Severe joint contractures disabling or restricting lower limb movements 9. Haematological disorders with increased risk of bleeding during surgical interventions 10. Participation in another study with investigational drug within the 30 days preceding and during the present study 11. Congenital or acquired lower limb abnormalities (affection of joints and bone) 12. Women who are pregnant or breast feeding or planning a pregnancy during the course of the study 13. Lack of safe contraception 14. Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological problems, dementia etc. 15. Known or suspected non-compliance, drug or alcohol abuse 16. Current or prior malignancy
Where this trial is running
Zurich
- Balgrist University Hospital — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Lennart H Stieglitz, MD — University Hospital Zurich, Neurosurgery
- Study coordinator: Lennart H Stieglitz, MD
- Email: Lennart.Stieglitz@usz.ch
- Phone: +4144255
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.