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| Name | Class |
|---|---|
| University of Aarhus | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Sex- and age matched, healthy control. Will only have baseline DKI and MEG performed. |
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| ALS without PBA | Active Comparator | ALS patient without PBA, either at baseline and 6 month follow-up |
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| ALS with PBA | Active Comparator | ALS patient with PBA, either at baseline or follow-up |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diffusion Kurtosis Imaging (DKI) | Other | Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean kurtosis | 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 | Baseline measurement and up to 6 month follow-up measurements |
| Spectral connectivity | 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) | Baseline measurement and up to 6 month follow-up measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Holm Steenkjær | Contact | +4597660000 | c.steenkjaer@rn.dk | |
| Blicher | Contact | +4522144295 | Au568472@uni.au.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University hospital | Recruiting | Aalborg | Northern Jutland | 9500 | Denmark |
Individual participant data is not planned to be available to other researchers. However findings from this study is planned to be published in peer-reviewed journal regardless of positive/negative findings
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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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.
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| Resting State Magnetoencephalography | Other | Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG) |
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| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |