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Recruiting NCT04059276

CNS Changes Following Stroke

Observational Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI, MRI.
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.
  • Diagnostic test MRI
    We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.

Primary outcome measures

  • Conventional magnetic resonance imaging (MRI) parameter [Time frame: Up to 50 weeks]]
Secondary outcome measures (2)
  • Magnetic resonance spectroscopy (MRS) parameter [Time frame: Up to 50 weeks]
  • Functional MRI (fMRI) parameter [Time frame: Up to 50 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Switzerland · 1 center
  • Universitätsklinik Balgrist — Zurich

Identifiers

NCT: NCT04059276 · 2018-00937 - Stroke

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗