Systematic, longitudinal clinical neurological and observational imaging study of COVID-19.

• Conditions: Post-/Long-COVID; U09.9; Post COVID-19 condition, unspecified

• Registration Number: DRKS00028986
• Lead Sponsor: niversitätsklinikum RWTH Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2022-01-20
• Study Start: 2022-05-09
• Study Completion: 2024-05-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

Adult study participants
- Patients with a proven SARS-CoV-2 infection
- Presence of a written declaration of consent of the study participant in case of capacity to give consent

Exclusion Criteria

Study participants with incorporated metallic implants will not be allowed.
Pregnancy or lactation, traumatic brain injury, neurological or psychiatric disease (except for the neurological disease under study for patients), relevant and severe other medical conditions, e.g. metabolic, endocrinological or cardiac disorders, mental retardation, magnetic metallic implants (including intrauterine coil).
Other exclusion criteria:
- Body mass index (BMI, weight [kg]/height2 [cm2]) of >30.
Medical conditions:
- Epilepsy
Conditions:
- Pregnancy
- Uncertain knowledge of any pregnancy present
Contraceptives:
- Any type of intrauterine device
- Copper IUD
Metal-containing implants or devices in/on the body (all non-metal-containing implants / devices / patches will be subject to close scrutiny based on the MRI Safety Listing www.mrisafety.com):
- Pacemaker / Implanted pacemaker wires.
- Implanted defibrillator
- Drug pump / infusion device
- Pacing device / electrodes
- Non-MRI capable implants e.g. surgical screws, plates, nails, etc.
- Vascular/lumen filters, wire rings, wire spirals, stents, vascular clips
- Artificial heart valve
- Transdermal patches
- Epithesis (or partial epithesis)
- Shunts, catheters, wire sutures
Metal in/on the body:
- Splinter / gunshot injuries
- Metal splinters in the eye, even if everything has supposedly been removed
- piercing
Dental metals:
- Any type of implant in the jawbone area / dental implant older than 20 years.
- No contraindication: amalgam fillings, inlays, crowns, single teeth covered with crown gold as a denture support point for a type of denture called a telescopic denture, fixed screw dentures
Other:
- Cochlear implant
- tympanostomy tube
- tattoos/permanent make-up (only after careful examination and special permission)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Systematic, longitudinal assessment of neurological, neuropsychological, and fluid (blood and stool samples) findings and MRI-based CNS changes after SARS-CoV-2 infection.

Secondary Outcome Measures

Name	Time	Method
Identification of clinical, fluid and imaging biomarkers, risk factors and predictors of post-COVID-19 syndrome.