Identify and further explore the structural brain alterations in ALS patients in comparison to healthy controls and to investigate the correlations of anatomical changes with clinical variables.
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Cortical thickness will be measured and compared with controls and
non-affected cortex in the same subjects (3 and 7Tesla); 2. Motor pathways with
DTI and probabilistic fibertracking (3Tesla); 3. Functional connectivity in
motor pathways, with resting-state fMRI and probabilistic independent component
analysis (3Tesla and 7Tesla).
Secondary outcome
The structural changes will be regarded in relation to the clinical condition,
duration of illness and clinical parameters of motor function
Background summary
Neuropathological as well as radiological studies have demonstrated structural
changes in brain and spinal cord of patients with amyotrophic lateral sclerosis
(ALS) for example white matter changes and cortical atrophy especially in the
motor cortex.
Study objective
Identify and further explore the structural brain alterations in ALS patients
in comparison to healthy controls and to investigate the correlations of
anatomical changes with clinical variables.
Study design
Observational cross sectional study
Study burden and risks
The participants will undergo clinical assessment, 3Tesla and 7Tesla MRI in the
UMC Utrecht. For the individual participant there are no direct benefits. The
information acquired by this research project may provide new insights in
diagnosing, measuring disease progression and pathogenesis of ALS/MND.
Heidelberglaan 100
3584CX Utrecht
NL
Heidelberglaan 100
3584CX Utrecht
NL
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL23896.041.08 |