CNS Changes Following Stroke

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 CNS undergoes following stroke and how these changes relate to clinical measures. Both macroscopic and microscopic changes of the brain and the spinal cord will be examined in stroke 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 motor and sensory testing to understand i) the structural and functional interplay between spinal and supraspinal neural circuits after stroke possibly driven by beneficial plasticity/regeneration vs. maladaptive plasticity/degeneration and ii) 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: Stroke
• Intervention / Treatment: Diagnostic test: MRI; Diagnostic test: MRI

• Study Type: Observational
• Enrollment (Estimated): 35

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; Phone Number: +41 44 510 72 08; Email: simon.schading@balgrist.ch
    • Contact: Sanne Kikkert; Phone Number: +41 44 633 27 15; Email: sanne.kikkert@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with stroke and healthy subjects.

Description

Inclusion Criteria - Patients:

• Age 18-80
• Stroke (> 3months)
• Signed informed consent

Exclusion Criteria - Patients:

• Contraindications to magnetic resonance imaging
• Neurological impairment of body function impairments not induced by stroke
• BMI > 40
• Pregnancy
• Claustrophobia

Inclusion Criteria - Healthy subjects:

• Age 18-80
• Signed informed consent

Exclusion Criteria - Healthy subjects:

• Contraindications to magnetic resonance imaging
• Pregnancy
• Neurological illness
• Impairment of body function induced by stroke
• Claustrophobia
• BMI >40

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects	Diagnostic test: MRI; We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.; Diagnostic test: MRI; We will examine chronic (>3 months post stroke) patients using functional, structural, and metabolic MRI in both the brain and the spinal cord.
Patients with stroke	Diagnostic test: MRI; We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.; Diagnostic test: MRI; We will examine chronic (>3 months post stroke) patients 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 spinal cord are assessed in chronic stroke 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 parameter are assessed in chronic stroke patients using MRS in the brain and spinal cord and compared to healthy controls	Up to 50 weeks
Functional MRI (fMRI) parameter	Brain activity or change of brain activities between 2 to 5 time points is assessed using fMRI during resting-state or a specific task in chronic stroke patients and compared to healthy controls	Up to 50 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

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: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2018-00937 - Stroke

Drug and device information, study documents

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