Actively Recruiting
Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
Led by Aalborg University Hospital · Updated on 2025-01-29
50
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
A
Aalborg University Hospital
Lead Sponsor
U
University of Aarhus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the brain connections in patients with amyotrophic lateral sclerosis (ALS), focusing on those who also experience pseudobulbar affect (PBA). This study aims to understand differences in brain structure and function using advanced imaging techniques. The research includes healthy controls and ALS patients both with and without PBA to compare these groups. Participants will undergo two non-invasive brain imaging procedures: diffusion kurtosis imaging (DKI), an MRI method that captures detailed diffusion signals in brain tissue, and resting state magnetoencephalography (MEG), which records brain activity. Healthy controls will have only baseline imaging, while ALS patients may be assessed at baseline and again after six months to track changes over time. During the study, participants will have brain imaging at the start and possibly at six months later. Researchers will measure mean kurtosis and spectral connectivity to analyze brain structure and function. The study is non-randomized and does not involve any treatment. Participants will be monitored for their ability to complete surveys and cooperate, and safety will be ensured by following guidelines for MRI and MEG scans.
CONDITIONS
Brief Title
Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with ALS within the last 6 months according to Gold Coast Criteria
You will not qualify if you...
- Unable to answer surveys by oneself or with assistance (e.g., computer, tablet, or telephone interview)
- Unable to cooperate with study procedures
- Pregnancy
- Drug addiction (non-prescribed use of cannabis, opioids, or other narcotics)
- Alcohol addiction (more than 21 units per week)
- Lesional neurological diseases such as stroke, tumor, or multiple sclerosis
- Epilepsy
- Neurodegenerative diseases other than ALS
- Severe psychiatric diseases such as major depression, bipolar disorder, or schizophrenia
- Contraindications for MRI or MEG scans based on hospital guidelines
- Severe liver or kidney disease
- Dysregulated heart disease
- Ongoing treatment with antidepressants or antipsychotics at recruitment
- Diagnosed with frontotemporal dementia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline brain imaging assessments including Diffusion Kurtosis Imaging (DKI) and Resting State Magnetoencephalography (MEG).
1 visit (in-person)
Duration - Up to 6 months
Participants with ALS may return for follow-up imaging assessments up to 6 months after baseline to evaluate changes in brain structure and function.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Aalborg University hospital
Aalborg, Northern Jutland, Denmark, 9500
Actively Recruiting
Research Team
C
Christian Holm Steenkjær
B
Blicher
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
3
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