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NCT Number: NCT03772548

CNS Changes Following SCI

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Diagnostic Test

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.

Primary outcomes

  1. Conventional magnetic resonance imaging (MRI) parameter

    Time frame: Up to 50 weeks

    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

Secondary outcomes

  1. Magnetic resonance spectroscopy (MRS) parameter

    Time frame: Up to 50 weeks

    Metabolic parameters are assessed in acute to chronic SCI patients using MRS in the brain and cervical spinal cord and compared to healthy controls

  2. Change of functional MRI (fMRI) parameter between 2 to 4 time points

    Time frame: Up to 50 weeks

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Maryam Seif, PD Dr.

CONTACT

[email protected]

+41 44 510 72 14

Sanne Kikkert

CONTACT

[email protected]

+41 44 633 27 15

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2018
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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