NL-OMON34004
Completed
Not Applicable
Imaging in amyotrophic lateral sclerosis; novel biomarker research with 7Tesla MRI - Imaging in ALS; 7Tesla MRI
niversitair Medisch Centrum Utrecht0 sites140 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- motor neuron disease
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 140
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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