Amyotrophic Lateral Sclerosis, Pseudobulbar Affect
Conditions
Keywords
Diffusion Kurtosis Imaging, Magnetoencephalography, Connectivity
Brief summary
The investigators aim to elucidate characteristics of structural and functional brain connectivity in patients with amyotrophic lateral sclerosis (ALS) and pseudobulbar affect (PBA) using diffusion kurtosis imaging (DKI) and magnetoencephalography (MEG).
Interventions
Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue
OTHERResting State Magnetoencephalography
Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
Sponsors
University of Aarhus
Aalborg University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Longitudinal imaging study. Baseline acquisition of DKI and resting state MEG of ALS and matched healthy controls. Participants with ALS will be monitored for a period of 6 months for symptoms of PBA. If developed, or not developed after 6 months, follow-up DKI and MEG will be acquired. An additional sub-study will be performed in patients with ALS and newly developed PBA, where resting state MEG will be acquired after at least 7 days of symptomatic treatment independent of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosed with ALS in the last 6 months according to Gold Coast Criteria
Exclusion criteria
* \- Lack of ability to answer survey through own ability or through a surrogate, for example by hand controlled, eye-controlled computer and/or tablet, or through telephone interview. * Lack of ability to cooperate. * Pregnancy * Drug addiction defined as the non-prescribed use of cannabis, opioids, or other narcotics. * Alcohol addiction defined as over 21 units weekly. * Lesional neurological diseases, such as stroke, tumor or multiple sclerosis * Epilepsy * Neurodegenerative diseases other than ALS * Severe psychiatric disease such as major depression disorder, bipolar disease or schizophrenia * Contraindication for MRI and MEG scan according to hospital guidelines * Severe liver or kidney disease * Dysregulated heart disease * Ongoing treatment with any antidepressants or any antipsychotics at recruitment. * Diagnosed with frontotemporal dementia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean kurtosis | Baseline measurement and up to 6 month follow-up measurements | A measurement of kurtosis diffusion signal in pseudobulbar affect-affiliated brains areas (prefrontal lobe, pons, cerebellum, motor cortex, temporal lobe) derived from Diffusion kurtosis imaging (DKI)-MRI |
| Spectral connectivity | Baseline measurement and up to 6 month follow-up measurements | Estimation of connectivity (correlation between spikes of activity) between pseudobulbar affect afflilated cortical brain areas (prefrontal cortex, motor cortex, temporal lobe) derived through resting state magnetoencelphalography (MEG) |
Countries
Denmark
Contacts
Primary ContactChristian Holm Steenkjær
Backup ContactBlicher
Outcome results
None listed