Multiple Sclerosis Clinical Trial
Official title:
Neurophysiological Estimates of Cortical Grey and White Matters Damage in Patients With Multiple Sclerosis
Main aim of this study will be the evaluation of the neurophysiological techniques of Transcranial Magnetic Stimulation (TMS) via electroencephalography (EEG) co-registration (TMS-EEG) with the study of TEPs (TEP: transcranial evoked potentials) as surrogates of white matter and grey matter functional integrity in patients with Multiple Sclerosis (MS). Data will be compared with those obtained from a group of healthy control subjects. Secondary aim will be the longitudinal evaluation of these neurophysiological parameters in MS patients during routine clinical and radiological evaluations, performed according to clinical practice, for 12 months. To this aim a longitudinal multicenter study will be carried out, interventional (for neurophysiological techniques) and observational (for clinical and radiological evaluations), which involves the enrollment of 64 patients diagnosed with MS. Patients will keep their usual therapeutic regimen and their usual clinical-radiological checks according to clinical practice. The control group will consist of 64 healthy subjects, enrolled with prior written informed consent, age and sex-matched with MS patients and selected among the caregivers of the patients. Healthy subjects will only undergo neurophysiological assessment at baseline. The neurophysiological evaluation will include the study of the propagation of potentials induced by stimulation. This method allows the study of cortical responses in terms of time domain and frequency, obtaining a measurement of interhemispheric connectivity and of microstructural and functional integrity of white matter. In the same way, these methods allow the assessment of grey matter integrity through the study of intracortical excitability.
Status | Not yet recruiting |
Enrollment | 128 |
Est. completion date | September 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - MS diagnosis according to the latest McDonald criteria Exclusion Criteria: - other neurological or immunological diseases - clinical relapses in the 30 days prior to the clinical and neurophysiological evaluation; - presence of conditions that contraindicate the execution of Transcranial Magnetic Stimulation (TMS) methods (history of epilepsy, pacemaker, recent head injury). |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Roma La Sapienza |
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* Note: There are 27 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes of Global cortico-cortical myelination | Power of the dominant frequency peak of the global electroencephalography (EEG) signal. | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of the Cortical-cortical coherence | Coherence between EEG signals recorded from distant channels. | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of the Local cortical-cortical myelination (motor) | Power of the dominant frequency peak of the local EEG signal on primary motor cortex (M1). | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of the Trans-callosal axonal myelination | Cortico-cortical coherence between EEG signals recorded on primary motor cortex (M1) areas bilaterally. | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of Interhemispheric signal propagation (iSP) | TMS-EMG measurement of the ipsilateral silent period (IpSP) | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of TMS-EEG measurement of the functional integrity of the grey matter: | Amplitude of the early components of Transcranial evoked potentials (TEPs). | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of TMS-EMG measurement of the functional integrity of the grey matter: | Resting Motor Threshold- (RMT) | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of clinical outcome measures | Clinical disability will be monitored with the Expanded Disability Status Scale (EDSS), performed by the same neurologist at each timepoint. | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of the Multiple Sclerosis Functional Composite (MSFC) | To assess walking, lower limb functionality, upper limb dexterity and cognitive function. | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of radiological outcome measures | Evaluation of the lesion load | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. | |
Primary | Changes of magnetic resonance imaging (MRI) number of lesions in T2 | Evaluation of new lesions in T2 compared to the previous evaluation. | Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline. |
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