An observational study in Amyotrophic Lateral Sclerosis, Frontotemporal Dementia and Multiple Sclerosis, sponsored by University of Dublin, Trinity College. Status unknown at 1 site in Ireland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-08.
Sponsored by University of Dublin, Trinity College · Observational
The purpose of this observational study is to improve understanding of the biology of why ALS, MS and FTD have different effects on different people and facilitate better measurement of the disease in future drug testing. To do this, brain and spinal cord neural network functionality will be measured over time, in addition to profiling of movement and non-movement symptoms, in large groups of patients, as well as in a population-based sample of the healthy population. Patterns of dysfunction which relate to patients' diagnosis and coinciding and future symptoms which align with categories of patients with similar prognoses will be investigated and their ability to predict incident patients' symptoms in future will be measured.
The aim of this project is to characterize spatiotemporal patterns of central nervous system dysfunction that correlate with clinical features of ALS, MS and FTD, to provide non-invasive electrophysiological measurements that can be used in a clinical setting to inform stratification of patients in clinical trials, and to provide data driven diagnostic and prognostic biomarkers and objective clinical trial outcome measures. Such dysfunction will be investigated by recording single- and paired-pulse transcranial magnetic stimulation (TMS)-associated electromyography (EMG) during rest and by recording electroencephalography (EEG) during rest and during cognitive-motor tasks.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's planned enrollment of 400 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Dublin, Trinity College is the lead sponsor of 72 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy controls and patients diagnosed with ALS, FTD or MS
In the case of non-control subjects, a clinical diagnosis of:
(i) Probable frontotemporal dementia (FTD) including behavioural variant FTD, semantic dementia or primary progressive aphasia) with supportive brain imaging or known FTD causing genetic mutation (ii) Multiple sclerosis (MS) according to the McDonald criteria (Polman et al., 2011) or (iii) Possible, probable or definite amyotrophic lateral sclerosis (ALS) according to the El Escorial Criteria Revised (Brooks et al. 2000)
Exclusion criteria:
Individuals from the Irish population with no psychiatric, psychological, neurological or muscular disease diagnosis
Procedure: 128 electrode electroencephalography (EEG) · Procedure: Transcranial magnetic stimulation (TMS)
Procedure: 128 electrode electroencephalography (EEG) · Procedure: Transcranial magnetic stimulation (TMS)
Procedure: 128 electrode electroencephalography (EEG) · Procedure: Transcranial magnetic stimulation (TMS)
Procedure: 128 electrode electroencephalography (EEG) · Procedure: Transcranial magnetic stimulation (TMS)
128 electrode EEG will be non-invasively recorded from electrodes placed in a montage over the scalp while the participant is resting or performing tasks designed to engage specific cortical motor networks of interest (cognitive, behavioural, motor and sensory)
Single and paired pulse TMS protocol will be delivered while surface bipolar EMG is recorded over hand muscles to interrogate corticospinal tract function and cortical motor network component functions
Diagnosis-related difference in EEG or TMS measurements
Differences in single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between those within each patient cohort and controls
Time frame: Baseline recording
Prognosis-related EEG or TMS measurements
Patient cohort single or paired pulse TMS measures or time and/or frequency domain EEG characteristics which show significant correlation to cognitive, behavioural, motor and/or sensory task performance, to disease duration or to survival time
Time frame: Baseline recording
Diagnosis-related changes in EEG or TMS measurements
Differences in rate of change (slope) across time of single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between those within each patient cohort relative to controls
Time frame: Baseline to final visit assessed up to 2 years after baseline
Prognosis-related changes in EEG or TMS measurements
Rates of change (slope) across time of patient cohort single or paired pulse TMS measures or time and/or frequency domain EEG characteristics which show significant correlation to cognitive, behavioural, motor and/or sensory task performance, to disease duration or to survival time
Time frame: Baseline to final visit assessed up to 2 years after baseline
Diagnosis-specific changes in EEG or TMS measurements
Differences in rate of change (slope) across time of single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between patient cohorts
Time frame: Baseline to final visit assessed up to 2 years after baseline
Diagnosis-specific difference in EEG or TMS measurements
Differences in single or paired pulse TMS measures or time and/or frequency domain EEG characteristics between patient cohorts
Time frame: Baseline recording
Plan to share: Yes — Raw data from this study may be made available in anonymized form upon request from qualified investigators subject to the approval by the Data Protection Office (DPO) and Office of Corporate Partnership and Knowledge Exchanges (OCPKE) in Trinity College Dublin, the University of Dublin.
Supporting information: Study protocol, Sap, Icf
This study is status unknown, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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University of Dublin, Trinity College