NCT03772548

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jul 2018Jun 2027

Study Start

First participant enrolled

July 18, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2018

Completed
20 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

9 years

First QC Date

November 21, 2018

Last Update Submit

December 8, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Conventional magnetic resonance imaging (MRI) parameter

    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

    Up to 50 weeks

Secondary Outcomes (2)

  • Magnetic resonance spectroscopy (MRS) parameter

    Up to 50 weeks

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

    Up to 50 weeks

Study Arms (2)

Patients with spinal cord injury

Diagnostic Test: MRI

Healthy subjects

Diagnostic Test: MRI

Interventions

MRIDIAGNOSTIC_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.

Patients with spinal cord injury

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with spinal cord injury and healthy subjects.

You may qualify if:

  • 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

You may not qualify if:

  • Contraindications to magnetic resonance imaging
  • Neurological impairment of body function impairments not induced by spinal cord injury
  • BMI \> 40
  • Pregnancy
  • Claustrophobia
  • Age 18-75
  • Signed Informed consent
  • Contraindications to magnetic resonance imaging
  • Pregnancy
  • Neurological illness
  • Impairment of body function induced by a spinal cord injury
  • Claustrophobia
  • BMI \> 40

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik Balgrist

Zurich, 8008, Switzerland

RECRUITING

Related Publications (1)

  • Kikkert S, Pfyffer D, Verling M, Freund P, Wenderoth N. Finger somatotopy is preserved after tetraplegia but deteriorates over time. Elife. 2021 Oct 19;10:e67713. doi: 10.7554/eLife.67713.

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Patrick Freund, Prof. Dr.

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

November 21, 2018

First Posted

December 11, 2018

Study Start

July 18, 2018

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations