MRI and neuropsychological evaluation in systemic sclerosis

Completed

• Conditions: scleroderma; systemic sclerosis; 10003816

• Registration Number: NL-OMON39408
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1. systemic sclerosis according to ACR criteria
2. presence of cognitive dysfunction, fatigue, concentration loss, and/or depression

Exclusion Criteria

1. Routine MRI-contraindications (e.g. instable metal implants, pacemaker/ICD,
vascular clips, fear).
2. Pregnancy

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The following questionnaires:<br /><br>Fatigue Indez (MVI-20)<br /><br>the Hospital Anxiety and<br /><br>Depression Scale (HADS)<br /><br>the Dissociation Experience Scale (DES), and the Neuropsychiatric Inventory<br /><br>(NPI).<br /><br><br /><br>The following functional neuropsychology tests are performed at the department<br /><br>of Neurology:<br /><br>a) global functioning (assessed by Mini mental state examination (MMSE),<br /><br>b) memory (Wechsler Memory scale),<br /><br>c) executive testing (Trails, Stroop, Wais-R substitution, number strike<br /><br>through test,<br /><br>d) language: (Word Fluency, naming pictures, writing and calculating)<br /><br>e) praxis (drawing a clock, map and cube).<br /><br><br /><br>The following neuroimaging parameters:<br /><br>1)Diffusion Weighted Imaging (DWI)<br /><br>2)Single Voxel Proton Magnetic Resonance Spectroscopy (H1-MRS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>