Examining changes in the central nervous system after spinal cord injury
Functional and Structural Changes in the Central Nervous System Following Spinal Cord Injury
This study is trying to see how spinal cord injuries affect the brain and nervous system in both new and long-term patients to help improve treatments for recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT05681936 on ClinicalTrials.gov |
What this trial studies
This observational study utilizes advanced functional MRI technology to investigate the functional and structural changes in the central nervous system of patients with spinal cord injuries. By focusing on the lumbosacral cord, the study aims to characterize the remaining neuronal activity of motor and sensory neurons following trauma-induced neurodegeneration. The findings will help determine the impact of spinal neuronal function on potential regeneration therapies for spinal cord injury patients. The study includes both chronic and acute spinal cord injury patients, as well as those with neurogenic bladder dysfunction undergoing treatment.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with chronic traumatic spinal cord injuries or acute traumatic spinal cord injuries, as well as patients with neurogenic bladder dysfunction undergoing specific treatments.
Not a fit: Patients under 18, those with contraindications for MRI, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of spinal cord function and improve therapeutic strategies for spinal cord injury patients.
How similar studies have performed: Other studies utilizing functional MRI for spinal cord injury assessment have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years * Informed consent * Willing to take part and follow requirements of the protocol Patients additionally need to fulfil the following study-specific inclusion criteria: Cross-sectional study: * Chronic traumatic SCI (\> 12 months after injury) or * Diagnosed degenerative spondylotic myelopathy (DCM) Longitudinal study: * Acute traumatic SCI (\< 2 months after injury) or * Patients with neurogenic lower urinary tract dysfunction (NLUTD) who undergo routine tibial nerve stimulation (TNS) treatment as part of their rehabilitation (but independently of this study) at Balgrist University Hospital Exclusion Criteria: * Age \< 18 years * Contraindications for MRI (presence of pacemaker or other type of stimulator in the body, presence of metallic foreign body in or on the body, etc.); we will comply with the imaging center's (SCMI) guidelines and in case of doubt we will exclude the participant from the study * No informed consent * History of psychiatric or neurological disease, apart from those induced by SCI (e.g.epilepsy) * History of skull opening or head trauma * Known or suspected non-adherence, drug or alcohol abuse * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. * Women who are pregnant (when uncertain, participants will undergo urine testing) or breastfeeding * Intention to become pregnant during the course of the study * Body mass index (BMI) \> 35 * Individuals especially in need of protection (according to Research with Human Subjects published by the Swiss Academy of Medical Sciences)
Where this trial is running
Zurich
- Balgrist University Hospital — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Patrick Freund, Prof. Dr. med. Dr. rer. nat. — University of Zurich
- Study coordinator: Gergely David, Dr.
- Email: gergely.david@balgrist.ch
- Phone: +41 44 510 72 13
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.