Clinical trial NCT03772548: CNS Changes Following SCI
Official title: Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Cord Injuries
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spinal cord injury and healthy subjects.

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

Primary outcomes:
measure: Conventional magnetic resonance imaging (MRI) parameter
timeFrame: Up to 50 weeks
Secondary outcomes:
measure: Magnetic resonance spectroscopy (MRS) parameter
timeFrame: Up to 50 weeks
measure: Change of functional MRI (fMRI) parameter between 2 to 4 time points
timeFrame: Up to 50 weeks
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Universitätsklinik Balgrist
Study officials:
affiliation: University of Zurich
name: Patrick Freund, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kikkert S, Pfyffer D, Verling M, Freund P, Wenderoth N. Finger somatotopy is preserved after tetraplegia but deteriorates over time. Elife. 2021 Oct 19;10:e67713. doi: 10.7554/eLife.67713.