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

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).

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis; Pseudobulbar Affect
• Intervention / Treatment: Other: Diffusion Kurtosis Imaging (DKI); Other: Resting State Magnetoencephalography

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian Holm Steenkjær; Phone Number: +4597660000; Email: c.steenkjaer@rn.dk
• Study Contact Backup: Name: Blicher; Phone Number: +4522144295; Email: Au568472@uni.au.dk

Study Locations

• Denmark
  • Northern Jutland
    • Aalborg, Northern Jutland, Denmark, 9500
      • Recruiting
      • Aalborg University Hospital
      • Contact: Christian Steenkjaer; Phone Number: 22144295

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Sex- and age matched, healthy control. Will only have baseline DKI and MEG performed.	Other: Diffusion Kurtosis Imaging (DKI); Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue; Other: Resting State Magnetoencephalography; Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
Active Comparator: ALS without PBA; ALS patient without PBA, either at baseline and 6 month follow-up	Other: Diffusion Kurtosis Imaging (DKI); Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue; Other: Resting State Magnetoencephalography; Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
Active Comparator: ALS with PBA; ALS patient with PBA, either at baseline or follow-up	Other: Diffusion Kurtosis Imaging (DKI); Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue; Other: Resting State Magnetoencephalography; Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 29, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Magnetoencephalography; Connectivity; Diffusion Kurtosis Imaging
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: F2024-014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No