EEG and TMS-based Biomarkers of ALS, MS and FTD

Last updated: June 2, 2021
Sponsor: University of Dublin, Trinity College
Overall Status: Active - Recruiting

Phase

N/A

Condition

Amyotrophic Lateral Sclerosis (Als)

Neurologic Disorders

Multiple Sclerosis

Treatment

N/A

Clinical Study ID

NCT04918251
CRFSJ00170
CRFSJ00171
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Age >18 years and able to give informed written or verbal (in the presence of twowitnesses) consent.
  • In the case of non-control subjects, a clinical diagnosis of: (i) Probable frontotemporal dementia (FTD) including behavioural variant FTD, semanticdementia or primary progressive aphasia) with supportive brain imaging or known FTDcausing genetic mutation (ii) Multiple sclerosis (MS) according to the McDonaldcriteria (Polman et al., 2011) or (iii) Possible, probable or definite amyotrophiclateral sclerosis (ALS) according to the El Escorial Criteria Revised (Brooks et al.

Exclusion

Exclusion criteria:

  • Any diagnosed neurological/muscular disease other than ALS, MS or FTD
  • Use of neuro- or myo-modulatory medications except riluzole
  • Inability to participate due to disease-related motor symptoms (e.g. inability to sitfor the required time or click the mouse to respond)
  • Upper body metallic implants
  • History of seizure disorders in the participant or immediate family members
  • Anxiety-induced fainting
  • Regular migraine
  • Evidence of significant respiratory insufficiency
  • Sleep time >2 hours below normal and/or alcohol consumption the night before datacollection (in which case, recording session will be rescheduled).

Study Design

Total Participants: 400
Study Start date:
September 01, 2012
Estimated Completion Date:
April 30, 2023

Study Description

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.

Connect with a study center

  • Academic Unit of Neurology, Trinity College Dublin, The University of Dublin

    Dublin, Leinster Dublin 2
    Ireland

    Active - Recruiting

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