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

NCT06396260 | Recruiting DMC

• 1 other identifier: F2024-014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Amyotrophic Lateral Sclerosis; Pseudobulbar Affect

Keywords

Diffusion Kurtosis Imaging; Magnetoencephalography; Connectivity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Control

ACTIVE COMPARATOR

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

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

ALS without PBA

ACTIVE COMPARATOR

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

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

ALS with PBA

ACTIVE COMPARATOR

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

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

Interventions

Diffusion Kurtosis Imaging (DKI) OTHER

Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue

ALS with PBA; ALS without PBA; Control

Resting State Magnetoencephalography OTHER

Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)

ALS with PBA; ALS without PBA; Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with ALS in the last 6 months according to Gold Coast Criteria

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Aalborg University hospital

Aalborg, Northern Jutland, 9500, Denmark

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Christian Holm Steenkjær

CONTACT

+4597660000; c.steenkjaer@rn.dk

Blicher

CONTACT

+4522144295; Au568472@uni.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 2, 2024
• Study Start: May 26, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)