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

Not Applicable

Recruiting

• Conditions: Amyotrophic Lateral Sclerosis; Pseudobulbar Affect
• Interventions: Other: Diffusion Kurtosis Imaging (DKI); Other: Resting State Magnetoencephalography

• Registration Number: NCT06396260
• Lead Sponsor: Aalborg University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Study Start: 2024-05-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2026-10-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALS without PBA	Diffusion Kurtosis Imaging (DKI)	ALS patient without PBA, either at baseline and 6 month follow-up
ALS without PBA	Resting State Magnetoencephalography	ALS patient without PBA, either at baseline and 6 month follow-up
ALS with PBA	Resting State Magnetoencephalography	ALS patient with PBA, either at baseline or follow-up
Control	Diffusion Kurtosis Imaging (DKI)	Sex- and age matched, healthy control. Will only have baseline DKI and MEG performed.
Control	Resting State Magnetoencephalography	Sex- and age matched, healthy control. Will only have baseline DKI and MEG performed.
ALS with PBA	Diffusion Kurtosis Imaging (DKI)	ALS patient with PBA, either at baseline or follow-up

Primary Outcome Measures

Name	Time	Method
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)
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

Trial Locations

Locations (1)

Aalborg University hospital; 🇩🇰 Aalborg, Northern Jutland, Denmark