Exploring brain connectivity in ALS and emotional symptoms
Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
This study is testing how brain connections in people with ALS relate to emotional symptoms like sudden laughter or crying to better understand what's happening in their brains.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Aalborg University Hospital Academic / other |
| Locations | 1 site (Aalborg, Northern Jutland) |
| Trial ID | NCT06396260 on ClinicalTrials.gov |
What this trial studies
This study investigates the structural and functional brain connectivity in patients diagnosed with amyotrophic lateral sclerosis (ALS) who also experience pseudobulbar affect (PBA). Utilizing advanced imaging techniques such as diffusion kurtosis imaging (DKI) and resting state magnetoencephalography (MEG), the researchers aim to gain insights into the neural networks involved in these conditions. By understanding these connectivity patterns, the study hopes to shed light on the underlying mechanisms of PBA in ALS patients.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with ALS within the last six months who do not have significant comorbid conditions.
Not a fit: Patients with severe psychiatric disorders, other neurodegenerative diseases, or contraindications for MRI and MEG scans may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and management of emotional symptoms in ALS patients.
How similar studies have performed: While studies on brain connectivity in ALS exist, this specific approach using DKI and MEG for PBA is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Aalborg, Northern Jutland
- Aalborg University hospital — Aalborg, Northern Jutland, Denmark (Recruiting)
Study contacts
- Study coordinator: Christian Holm Steenkjær
- Email: c.steenkjaer@rn.dk
- Phone: +4597660000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.