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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06396260
• Other study ID #: F2024-014
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 23, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2026
• Est. primary completion date: October 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease

Intervention

Other:
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Aalborg University Hospital	University of Aarhus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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