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CNS Changes Following SCI

University of Zurich (UZH) logo

University of Zurich (UZH)

Status

Enrolling

Conditions

Spinal Cord Injuries

Treatments

Diagnostic Test: MRI

Study type

Observational

Funder types

Other

Identifiers

NCT03772548
2018-00937 - SCI

Details and patient eligibility

About

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.

Enrollment

450 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

450 participants in 2 patient groups

Patients with spinal cord injury
Treatment:
Diagnostic Test: MRI
Diagnostic Test: MRI
Healthy subjects
Treatment:
Diagnostic Test: MRI
Diagnostic Test: MRI

Trial contacts and locations

1

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Central trial contact

Sanne Kikkert; Maryam Seif, PD Dr.

Data sourced from clinicaltrials.gov

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