Recruiting NCT06396260
Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diffusion Kurtosis Imaging (DKI), Resting State Magnetoencephalography.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis, Pseudobulbar Affect. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Interventions
- Other Diffusion Kurtosis Imaging (DKI)
Non-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue - Other Resting State Magnetoencephalography
Non-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
Primary outcome measures
- Mean kurtosis [Time frame: Baseline measurement and up to 6 month follow-up measurements]
- Spectral connectivity [Time frame: Baseline measurement and up to 6 month follow-up measurements]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Denmark · 1 center
- Aalborg University hospital — Aalborg
Identifiers
NCT: NCT06396260 · F2024-014