| NCT ID | NCT03772548 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Zurich |
| Condition | Spinal Cord Injuries |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2018-07-18 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2018-07-18 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following spinal cord injury and how these changes relate to clinical measures. Both macroscopic and microscopic changes of the brain and the spinal cord will be examined in SCI patients and compared to healthy controls. In terms of structural plasticity, we aim to identify MR biomarkers that allow predicting the course of the patient's neurological status and accurately describe the course of the disease and the recovery. Importantly, we aim to investigate which factors scale the patients' symptoms. In terms of functional plasticity, we will combine fMRI with behavioural testing to understand which clinical and behavioural determinants drive functional hand representations in the primary somatosensory and motor cortices to be maintained and which determinants drive reorganisation of functional representations following sensory input loss. We will further investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, aim to better understand the mechanistic underpinnings of functional reorganisation.
Eligibility Criteria
Inclusion Criteria - Patients: * Age 18-75 * Traumatic or non-traumatic spinal cord injury (para- and tetraplegia) * Acute (\<4 weeks post SCI) to chronic SCI (\> 6 months post SCI) * Signed informed consent Exclusion Criteria - Patients: * Contraindications to magnetic resonance imaging * Neurological impairment of body function impairments not induced by spinal cord injury * BMI \> 40 * Pregnancy * Claustrophobia Inclusion Criteria - Healthy subjects: * Age 18-75 * Signed Informed consent Exclusion Criteria - Healthy subjects: * Contraindications to magnetic resonance imaging * Pregnancy * Neurological illness * Impairment of body function induced by a spinal cord injury * Claustrophobia * BMI \> 40
Contact & Investigator
Patrick Freund, Prof. Dr.
PRINCIPAL INVESTIGATOR
University of Zurich
Frequently Asked Questions
Who can join the NCT03772548 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03772548 currently recruiting?
Yes, NCT03772548 is actively recruiting participants. Contact the research team at maryam.seif@balgrist.ch for enrollment information.
Where is the NCT03772548 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT03772548 clinical trial?
NCT03772548 is sponsored by University of Zurich. The principal investigator is Patrick Freund, Prof. Dr. at University of Zurich. The trial plans to enroll 450 participants.