Association of Quantitative and Functional Imaging With Clinical Outcome After Spinal Cord Injury

NCT03886610 | Completed

• 1 other identifier: 2018-37
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

The overall study aim is to provide additional magnetic resonance imaging parameters of the cervical spinal cord, brainstem and brain and a better understanding of changes after spinal cord injury (SCI) and to define new magnetic resonance (MR) biomarkers to correlate with sensomotoric functioning and clinical outcome.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Change in Fractional Anisotropy (FA)

  Degree of anisotropy of a diffusion process (value between zero and one). A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions. A value of one means that diffusion occurs only along one axis and is fully restricted along all other directions. FA is a measure often used in diffusion imaging where it is thought to reflect fiber density, axonal diameter, and myelination in white matter.

  16-40 days after injury, 70-96 days after injury, 150- 186 days after injury

Secondary Outcomes (2)

• Change in Apparent Diffusion Coefficient (ADC)

  16-40 days after injury, 70-96 days after injury, 150- 186 days after injury

• Change in Relative Anisotropy (RA)

  16-40 days after injury, 70-96 days after injury, 150- 186 days after injury

Study Arms (3)

Healthy controls

Individuals without spinal cord injury

Other: Healthy controls

Subacute SCI patients

Subacute patients with spinal cord injury (duration \>2 weeks)

Other: Subacute SCI patients

Chronic SCI patients

Patients with chronic spinal cord injury (duration ≥24 months)

Other: Chronic SCI patients

Interventions

Healthy controls OTHER

individuals without spinal cord injury

Healthy controls

Subacute SCI patients OTHER

individuals with spinal cord injury ≥ 2 weeks

Subacute SCI patients

Chronic SCI patients OTHER

individuals with spinal cord injury ≥ 24 months

Chronic SCI patients

Eligibility Criteria

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

Study Population

* 20 healthy controls * 35 patients with subacute spinal cord injury * 20 patients with chronic spinal injury

You may qualify if:

• age between 18 and 80 years
• no previous history of severe cervical trauma, traumatic brain injury, cervical surgery or signs of neurological impairment and no known neurological disease.

You may not qualify if:

• not meeting the MRI screening requirements
• unable to give consent
• Subacute and chronic patients with spinal cord injury:
• lesion level at or below C3
• etiology of the spinal cord injury is traumatic or non-traumatic
• age between 18 and 80 years
• time of trauma or onset of symptoms for subacute SCI patients is more than 3 weeks and for the chronic SCI patients more than 2 years
• lesion level below L2
• other known pathology of the spinal cord/brain (e.g. MS) or progressive neurological disorders
• inability to meet the MRI screening requirements (e.g. pacemaker or other electronic devices),
• severe head trauma as defined by a Glasgow Coma Scale (GCS) of \< 14
• patients who are ventilator dependant

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• UMC Utrecht: collaborator

Study Sites (1)

Swiss Paraplegic Centre

Nottwil, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Officials

• Ernst Christiaanse, MD

  Swiss Paraplegic Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiologist

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: March 22, 2019
• Study Start: March 27, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)