Neurophysiological Assessment in Patients With Multiple Sclerosis
Neurophysiological Estimates of Cortical Grey and White Matters Damage in Patients With Multiple Sclerosis
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Neurophysiological assessment
- clinical assessment
What it measured
Main measures
Changes of Global cortico-cortical myelination
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
Nerve conduction testsChanges of the Cortical-cortical coherence
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
Nerve conduction testsChanges of the Local cortical-cortical myelination (motor)
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
Nerve conduction testsChanges of the Trans-callosal axonal myelination
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
Nerve conduction testsChanges of Interhemispheric signal propagation (iSP)
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
Nerve conduction testsChanges of TMS-EEG measurement of the functional integrity of the grey matter:
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
Myelin repairNerve conduction testsChanges of TMS-EMG measurement of the functional integrity of the grey matter:
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
Nerve conduction testsChanges of clinical outcome measures
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
Disability progressionChanges of the Multiple Sclerosis Functional Composite (MSFC)
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
Disability progressionThinking and memoryWalking and mobilityArm and hand functionChanges of radiological outcome measures
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
MRI lesionsChanges of magnetic resonance imaging (MRI) number of lesions in T2
Baseline (T0) and at 6 and 12 months. Healthy controls will undergo only the neurophysiological evaluation at baseline.
MRI lesions
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
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).
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
Boniface SJ, Mills KR, Schubert M. Responses of single spinal motoneurons to magnetic brain stimulation in healthy subjects and patients with multiple sclerosis. Brain. 1991 Feb;114 ( Pt 1B):643-62. doi: 10.1093/brain/114.1.643.Background
Casula EP, Maiella M, Pellicciari MC, Porrazzini F, D'Acunto A, Rocchi L, Koch G. Novel TMS-EEG indexes to investigate interhemispheric dynamics in humans. Clin Neurophysiol. 2020 Jan;131(1):70-77. doi: 10.1016/j.clinph.2019.09.013. Epub 2019 Oct 24.Background
Conte A, Lenzi D, Frasca V, Gilio F, Giacomelli E, Gabriele M, Bettolo CM, Iacovelli E, Pantano P, Pozzilli C, Inghilleri M. Intracortical excitability in patients with relapsing-remitting and secondary progressive multiple sclerosis. J Neurol. 2009 Jun;256(6):933-8. doi: 10.1007/s00415-009-5047-0. Epub 2009 Mar 1.Background
Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, Syndulko K, Weinshenker BG, Antel JP, Confavreux C, Ellison GW, Lublin F, Miller AE, Rao SM, Reingold S, Thompson A, Willoughby E. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999 May;122 ( Pt 5):871-82. doi: 10.1093/brain/122.5.871.Background
Dobson R, Giovannoni G. Multiple sclerosis - a review. Eur J Neurol. 2019 Jan;26(1):27-40. doi: 10.1111/ene.13819. Epub 2018 Nov 18.Background
Ferrazzano G, Crisafulli SG, Baione V, Tartaglia M, Cortese A, Frontoni M, Altieri M, Pauri F, Millefiorini E, Conte A. Early diagnosis of secondary progressive multiple sclerosis: focus on fluid and neurophysiological biomarkers. J Neurol. 2021 Oct;268(10):3626-3645. doi: 10.1007/s00415-020-09964-4. Epub 2020 Jun 5.Background
Giovannoni G, Lang S, Wolff R, Duffy S, Hyde R, Kinter E, Wakeford C, Sormani MP, Kleijnen J. A Systematic Review and Mixed Treatment Comparison of Pharmaceutical Interventions for Multiple Sclerosis. Neurol Ther. 2020 Dec;9(2):359-374. doi: 10.1007/s40120-020-00212-5. Epub 2020 Sep 28.Background
Goodkin DE, Hertsgaard D, Seminary J. Upper extremity function in multiple sclerosis: improving assessment sensitivity with box-and-block and nine-hole peg tests. Arch Phys Med Rehabil. 1988 Oct;69(10):850-4.Background
Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026.Background
Houdayer E, Comi G, Leocani L. The Neurophysiologist Perspective into MS Plasticity. Front Neurol. 2015 Sep 3;6:193. doi: 10.3389/fneur.2015.00193. eCollection 2015.
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History
Started
Oct 2021
Main results due
Jul 2023
Finished
Sept 2023