Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect

Aalborg University Hospital

Status: Enrolling

Conditions: Pseudobulbar Affect; Amyotrophic Lateral Sclerosis

Treatments: Other: Diffusion Kurtosis Imaging (DKI); Other: Resting State Magnetoencephalography

Study type: Interventional

Funder types: Other

Identifiers

NCT06396260

F2024-014

Details and patient eligibility

About

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).

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Control

Active Comparator group

Description:

Sex- and age matched, healthy control. Will only have baseline DKI and MEG performed.

Treatment:

Other: Resting State Magnetoencephalography

Other: Diffusion Kurtosis Imaging (DKI)

ALS without PBA

Active Comparator group

Description:

ALS patient without PBA, either at baseline and 6 month follow-up

Treatment:

Other: Resting State Magnetoencephalography

Other: Diffusion Kurtosis Imaging (DKI)

ALS with PBA

Active Comparator group

Description:

ALS patient with PBA, either at baseline or follow-up

Treatment:

Other: Resting State Magnetoencephalography

Other: Diffusion Kurtosis Imaging (DKI)