Metabolic MRI of amyotrophic lateral sclerosis and mini strokes

Phase 1

• Conditions: Amyotrophic lateral sclerosisTransient ischemic attack; MedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2020-000352-36-DK
• Lead Sponsor: Christoffer Laustsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-13
• Last Update Posted: 11 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

All participants:
-Aged 18 – 85 years. The age and gender of the healthy controls of the main study will be matched to the patients in ALS and TIA groups
-Pre-menopausal women must be confirmed non-pregnant by an onsite test

ALS group:
-Fulfilling the 2015 revised El Escorial criteria
-Upper motor neuron symptoms

TIA group:
-TIA within the last 10 days. TIA is defined as symptoms shorter than 24 hours (time definition) with a likely vascular genesis (mimics such as urinary tract infection, hypoglycemia and migraine are excluded)
-Symptoms must include unilateral weakness of face and/or limb
-Symptom duration > 10 minutes

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

Contraindications for MRI with contrast:
-Chronic kidney disease
-Significant cardiac disease such as severe left ventricular outflow obstruction
-Significant obstructive lung disease or severe asthma
-Pacemaker, neurostimulator or cholera implant
-Metal foreign bodies such as fragments and irremovable piercings
-Unsafe medical implants (safety of heart valves, hips and the like must be confirmed)
-Intracranial clips or coils
-Claustrophobia
-Largest circumference including arms > 160 cm

Competing neurological, psychiatric, liver or systemic disease including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified