CNS Changes Following SCI

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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Diagnostic test: MRI; Diagnostic test: MRI

• Study Type: Observational
• Enrollment (Estimated): 285

Contacts and Locations

• Study Contact: Name: Simon Schading, MMed; Phone Number: +41 44 510 72 08; Email: simon.schading@balgrist.ch
• Study Contact Backup: Name: Sanne Kikkert; Phone Number: +41 44 633 27 15; Email: sanne.kikkert@balgrist.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8008
    • Recruiting
    • Universitätsklinik Balgrist
    • Contact: Simon Schading, MMed; Email: simon.schading@balgrist.ch
    • Contact: Sanne Kikkert; Email: sanne.kikkert@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal cord injury and healthy subjects.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects	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.; Diagnostic test: MRI; We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.
Patients with spinal cord injury	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.; Diagnostic test: MRI; We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Armin Curt, University of Zurich

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 2018-00937 - SCI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No