Amyotrophic Lateral SclerosisNCT06396260
Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
A study testing Diffusion Kurtosis Imaging (DKI) and Resting State Magnetoencephalography in people with Amyotrophic Lateral Sclerosis and Pseudobulbar Affect, run by Aalborg University Hospital at 1 site in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Pseudobulbar Affect
- What is being tested?
- Diffusion Kurtosis Imaging (DKI) and Resting State Magnetoencephalography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 26 May 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with ALS in the last 6 months according to Gold Coast Criteria
Who cannot join
- - 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University hospital
Aalborg, Northern Jutland, 9500
Christian Steenkjaer, 22144295
About this study
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
- Being tested
- Diffusion Kurtosis Imaging (DKI), Resting State Magnetoencephalography
- Keywords
- Diffusion Kurtosis Imaging, Magnetoencephalography, Connectivity
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion Kurtosis Imaging (DKI)Other
Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue
Resting State MagnetoencephalographyOther
Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Sex- and age matched, healthy control. Will only have baseline DKI and MEG performed. Receives: 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 Receives: Other: Diffusion Kurtosis Imaging (DKI); Other: Resting State Magnetoencephalography |
| ALS with PBA | Active comparator | ALS patient with PBA, either at baseline or follow-up Receives: Other: Diffusion Kurtosis Imaging (DKI); Other: Resting State Magnetoencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: Baseline measurement and up to 6 month follow-up measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start26 May 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Christian Holm Steenkjær, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06396260
- Sponsor's protocol ID
- F2024-014
- Status last verified
- Jan 2025
- First submitted
- 25 Apr 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
- ClinicalTrials.gov ID
- NCT06396260
- Acronym / sponsor ID
- F2024-014
- Conditions
- Amyotrophic Lateral Sclerosis, Pseudobulbar Affect
- Keywords
- Diffusion Kurtosis Imaging, Magnetoencephalography, Connectivity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 26 May 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Diffusion Kurtosis Imaging (DKI), Other: Resting State MagnetoencephalographySex- and age matched, healthy control. Will only have baseline DKI and MEG performed. |
| ALS without PBA | Active comparator | Other: Diffusion Kurtosis Imaging (DKI), Other: Resting State MagnetoencephalographyALS patient without PBA, either at baseline and 6 month follow-up |
| ALS with PBA | Active comparator | Other: Diffusion Kurtosis Imaging (DKI), Other: Resting State MagnetoencephalographyALS patient with PBA, either at baseline or follow-up |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with ALS in the last 6 months according to Gold Coast Criteria
Key exclusion criteria (14 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diffusion Kurtosis Imaging (DKI)Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue | Other | ALS with PBA, ALS without PBA, Control |
| Resting State MagnetoencephalographyNon-invasive method of measuring resting state brain activity through magnetoencephalography (MEG) | Other | ALS with PBA, ALS without PBA, Control |
Primary outcome
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion Kurtosis Imaging (DKI) and Resting State Magnetoencephalography in people with Amyotrophic Lateral Sclerosis and Pseudobulbar Affect, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Holm Steenkjær (+4597660000, c.steenkjaer@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean kurtosis (time frame: Baseline measurement and up to 6 month follow-up measurements). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.