Imaging in amyotrophic lateral sclerosis; novel biomarker research with 7Tesla MRI - Imaging in ALS; 7Tesla MRI

niversitair Medisch Centrum Utrecht0 个研究点目标入组 140 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1. Definite, probable, probable-laboratory supported or possible ALS according to the revised El Escorial World Federation of Neurology criteria, primary lateral sclerosis or progressive spinal muscular atrophy.
•2. Disease duration (at inclusion) more than 6 months and less than 36 months (disease onset is defined as the date of first symptoms excluding muscle cramps and fasciculations).
•3. Vital capacity (VC%) >= 70 % of normal value (slow expiration, best of a minimum of three and a maximum of five measurements, with a respiratory function validly assessable and spontaneous, non-assisted ventilation).
•4. Age 18 - 80 years (inclusive)
•5. Right-handedness
•6. Capable of thoroughly understanding the study information given; has signed the informed consent.

•1. Tracheostomy, tracheostomal ventilation of any type, non-invasive ventilation more than 16 hours/ day, or supplemental oxygen during the last three months prior to inclusion.
•2. Any medical condition or intoxication known to have an association with motor neuron dysfunction, which might confound or obscure the diagnosis of ALS.
•3. Presence of any other systemic or cerebral disease: diabetes, hypertension, dyslipidaemia and a history of stroke.
•4. Presence of pronounced swallowing disorders (which make it dangerous to lie supine in the MRI scanner)
•5. Contra-indication for 7Tesla MRI imaging (as established by the department)
•6. Left-handedness and ambidextrous
•7. Pregnancy

发起方

niversitair Medisch Centrum Utrecht