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NCT Number: NCT06396260

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).

Recruiting

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University hospital

Aalborg, Northern Jutland, 9500, Denmark

Location status: Recruiting

Location contact

Christian Steenkjaer

CONTACT

22144295

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diffusion Kurtosis Imaging (DKI)

Other

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

Resting State Magnetoencephalography

Other

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

Primary outcomes

  1. Mean kurtosis

    Time frame: 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

  2. Spectral connectivity

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Blicher

CONTACT

[email protected]

+4522144295

Christian Holm Steenkjær

CONTACT

[email protected]

+4597660000

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • University of Aarhus

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 2, 2024
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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