Study Purpose:
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.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis , Frontotemporal Dementia , Multiple Sclerosis
Study Type:
Observational
Type of Intervention:
N/A
Intervention Name:
N/A
Placebo:
N/A
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN, Academic Unit of Neurology, Trinity College Dublin, The University of Dublin
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN / email hidden; JavaScript is required / +353 1 896 4497
Full Study Summary:
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.
Study Sponsor:
University of Dublin, Trinity College
Estimated Enrollment:
400
Estimated Study Start Date:
09 / 01 / 2012
Estimated Study Completion Date:
04 / 01 / 2023
Posting Last Modified Date:
06 / 08 / 2021
Date Study Added to neals.org:
06 / 08 / 2021
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion criteria:- Age >18 years and able to give informed written or verbal (in the presence of two witnesses) consent.
- 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:
- 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 sit for 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 data collection (in which case, recording session will be rescheduled).
Academic Unit of Neurology, Trinity College Dublin, The University of Dublin | Recruiting
Orla Hardiman, BSc MB BCh BAO MD FRCPI FAAN / 018964497 / email hidden; JavaScript is required
Roisin McMackin, BA PhD / 0894888697 / email hidden; JavaScript is required
Dublin, Leinster
Dublin 2
Ireland