CNS Changes Following Stroke

NCT04059276 | Recruiting

• 1 other identifier: 2018-00937 - Stroke
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Magnetic resonance spectroscopy (MRS) parameter

  Up to 50 weeks

• Functional MRI (fMRI) parameter

  Up to 50 weeks

Study Arms (2)

Patients with stroke

Diagnostic Test: MRI

Healthy subjects

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stroke and healthy subjects.

You may qualify if:

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

You may not qualify if:

• Contraindications to magnetic resonance imaging
• Neurological impairment of body function impairments not induced by stroke
• BMI \> 40
• Pregnancy
• Claustrophobia
• Age 18-80
• Signed informed consent
• Contraindications to magnetic resonance imaging
• Pregnancy
• Neurological illness
• Impairment of body function induced by stroke
• Claustrophobia
• BMI \>40

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Patrick Freund, Prof. Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Seif, PD Dr.

CONTACT

+41 44 510 72 14; maryam.seif@balgrist.ch

Sanne Kikkert

CONTACT

+41 44 633 32 94; sanne.kikkert@balgrist.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 16, 2019
• Study Start: December 1, 2019
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Locations

CH (1)