euromodulation strategies to enhance the effects of gait rehabilitation in multiple sclerosis patients with cerebellar ataxia - New strategies in neurological diseases

IRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO0 个研究点目标入组 45 人开始时间: 2020年11月5日最近更新: 2021年1月5日

适应症

试验速览

暂无简介。

•Aged 18–70 years,
•With clinically defined multiple sclerosis (McDonald 2010),
•Able to complete two trials of the timed 25-foot walk (T25FW)
•EDSS between 4 and 6,
•International Cooperative Ataxia Rating Scale (ICARS) walking capacities score =2,
•Pyramidal Functional System Score (FSS) =2.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•Onset of multiple sclerosis exacerbation within 90 days of screening,
•A history of seizures a history of seizures or the presence of vascular, infectious or methabolic lesions of the cerebral cortex leading to symptomatic seizures,
•Allergy to pyridine or tablet excipients
•Patients treated with drugs containing 4-aminopyridine,
•Any condition that would interfere with the conduct or interpretation of the study,
•Contraindication to the use of the Transcranial Magnetic Stimulator,
•Clinically significant abnormal laboratory values or electrocardiogram at screening,
•Patients with impaired renal function mild, moderate or severe (creatinine cleareance <80 ml/min),
•Patients treated with OCT2 inhibitors, for example cimetidine,
•Women were excluded if they were pregnant, lactating or of childbearing potential and not using adequate birth control.
•We set additional restrictions on changes in concomitant medications to avoid related changes in multiple sclerosis symptoms during the trial.

发起方

IRCCS FONDAZIONE ISTITUTO NEUROLOGICO NAZIONALE C. MONDINO