Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
NCT ID: NCT06396260
Last Updated: 2025-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-05-26
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
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.
OTHER
NONE
Study Groups
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Control
Sex- and age matched, healthy control. Will only have baseline DKI and MEG performed.
Diffusion Kurtosis Imaging (DKI)
Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue
Resting State Magnetoencephalography
Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
ALS without PBA
ALS patient without PBA, either at baseline and 6 month follow-up
Diffusion Kurtosis Imaging (DKI)
Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue
Resting State Magnetoencephalography
Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
ALS with PBA
ALS patient with PBA, either at baseline or follow-up
Diffusion Kurtosis Imaging (DKI)
Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue
Resting State Magnetoencephalography
Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
Interventions
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Diffusion Kurtosis Imaging (DKI)
Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue
Resting State Magnetoencephalography
Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
90 Years
ALL
Yes
Sponsors
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University of Aarhus
OTHER
Aalborg University Hospital
OTHER
Responsible Party
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Christian Holm Steenkjær
Principal Investigator
Locations
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Aalborg University hospital
Aalborg, Northern Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Christian Steenkjaer
Role: primary
Other Identifiers
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F2024-014
Identifier Type: -
Identifier Source: org_study_id
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