Examining changes in the central nervous system after 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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.