Structural and Functional Networks in ALS: An Insight Into Pseudobulbar Affect
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAalborg University Hospital
About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosed with ALS in the last 6 months according to Gold Coast Criteria
Disqualifiers
- 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Diffusion Kurtosis Imaging (DKI)
Other interventionNon-invasive MRI sequence which extracts information of diffusion signals from complex brain tissue
Resting State Magnetoencephalography
Other interventionNon-invasive method of measuring resting state brain activity through magnetoencephalography (MEG)
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: ControlActive comparator 2 interventions
Group B: ALS without PBAActive comparator 2 interventions
Group C: ALS with PBAActive comparator 2 interventions
Trial outcomes
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 measurements2
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 measurementsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aalborg University Hospital
Lead sponsor
University of Aarhus
Collaborator
Source ClinicalTrials.gov