CNS Changes Following SCI

Spinal Cord Injuries Clinical Trial

Official title:

Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03772548
• Other study ID #: 2018-00937 - SCI
• Status: Recruiting
• Start date: July 18, 2018
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: University of Zurich
• Contact: Simon Schading, MMed
• Phone: +41 44 510 72 08
• Email: simon.schading[@]balgrist.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 285
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Diagnostic Test:
• MRI
We will examine acute (<4 weeks post SCI) to chronic (>6 months post SCI) patients using functional, structural, and metabolic MRI in both the brain and the spinal cord.
• MRI
We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.

Locations

Country	Name	City	State
Switzerland	Universitätsklinik Balgrist	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conventional magnetic resonance imaging (MRI) parameter	Structural characteristics in the brain and cervical spinal cord are assessed in acute to chronic spinal cord injury (SCI) patients using conventional MRI and compared to healthy controls	Up to 50 weeks
Secondary	Magnetic resonance spectroscopy (MRS) parameter	Metabolic parameters are assessed in acute to chronic SCI patients using MRS in the brain and cervical spinal cord and compared to healthy controls	Up to 50 weeks
Secondary	Change of functional MRI (fMRI) parameter between 2 to 4 time points	Change of brain activities is assessed between 2 to 4 time points using fMRI during resting-state or a specific task in acute to chronic SCI patients and compared to healthy controls	Up to 50 weeks