High-field structural and functional MRI to investigate the substrates of fatigue in multiple sclerosis and to monitor the effect of tailored treatments.Pharmacological substudy. - ND

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 个研究点开始时间: 2011年2月2日最近更新: 2015年2月16日

适应症

试验速览

暂无简介。

•-No relapses and steroid treatment in the three months preceding study initiation;
•- No or only modest overall neurological impairment defined as an EDSS score of 4.0 or less;
•- No visual deficits;
•- No right upper limb impairment that may interfere with fMRI performance;
•- No pain disturbances;
•- No other neurological diseases;
•- No psychiatric or mood disorders;
•- No evidence of depression at the Montgomery and Asberg Depression Rating Scale (1979);
•- No epilepsy, learning disability, head injury, episodes of loss of consciousness or severe ongoing stressors;
•- No history of drug or alcohol abuse;
•- No concomitant therapy with antidepressant, baclofen, psychoactive, and steroids drugs as well as symptomatic treatment for fatigue;
•- For patients treated with interferons (IFN) or other immunomodulants: treatment should be started at least six months before MRI acquisition and fatigue should not be a side effect of IFN treatment;
•- No major medical illness including renal, hepatic or cardiac disease, or diabetes mellitus.
•- No pregnancy or breastfeeding;
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Recurrence-and steroid treatment in the three months preceding the start of the study;
•- Even modest global neurological damage defined by EDSS scores of 4.0 or less;
•- Visual impairment;
•- Direct damage to the upper limbs that may interfere with fMRI;
•- Pain disorder;
•- Other neurological disease;
•- Psychiatric disorder or mood;
•- Evidence of depression and the Montgomery Asberg Depression Rating Scale (1979);
•- Epilepsy, learning disabilities, head injury, episodes of loss of consciousness or severe stressors in progress;
•- Previous abuse of drugs or alcohol;
•- Concomitant treatment with antidepressants, baclofen, psychoactive drugs and steroids, as well as symptomatic treatment for fatigue;
•- Patients treated with interferon (IFN) or other immunomodulatory treatment with recent
•- Serious illness such as kidney disease, liver or heart, or diabetes mellitus.
•-Pregnant or lactating;

发起方

FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR