Deep brain stimulation to improve walking in patients with incomplete spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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
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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.