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RecruitingNCT06396260Updated Jan 29, 2025

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

An interventional study of Diffusion Kurtosis Imaging (DKI) and Resting State Magnetoencephalography in Amyotrophic Lateral Sclerosis and Pseudobulbar Affect, sponsored by Aalborg University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by Aalborg University Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Started May 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Amyotrophic Lateral Sclerosis
  • Pseudobulbar Affect

Keywords

  • Diffusion Kurtosis Imaging
  • Magnetoencephalography
  • Connectivity
03

In context

Motor Neuron Disease

717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.

This study's planned enrollment of 50 is above the median of 35 across 461 interventional studies indexed under Motor Neuron Disease.

Browse Motor Neuron Disease studies →

Lead sponsor

Aalborg University Hospital is the lead sponsor of 195 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Active comparator
    Control

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

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

  • Active comparator
    ALS without PBA

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

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

  • Active comparator
    ALS with PBA

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

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

Interventions

  • OtherDiffusion Kurtosis Imaging (DKI)

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

  • OtherResting State Magnetoencephalography

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline measurement and up to 6 month follow-up measurements

  2. 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)

    Time frame: Baseline measurement and up to 6 month follow-up measurements

07

Study locations

1 of 1 sites recruiting
  • Aalborg University hospital
    Aalborg, Northern Jutland 9500, Denmark
    • Christian Steenkjaer · Contact · 22144295
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — 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

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06396260
Lead sponsor
Aalborg University Hospital
Collaborators
University of Aarhus
Responsible party
Christian Holm Steenkjær (Principal Investigator, Aalborg University Hospital) — Principal investigator
First posted
May 2, 2024
Start date
May 26, 2024
Primary completion
Oct 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 29, 2025

Study contacts

Christian Holm Steenkjær
Contact
c.steenkjaer@rn.dk
+4597660000
Blicher
Contact
Au568472@uni.au.dk
+4522144295

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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