Protocol of study for the evaluation of the efficacy of rivastigmine on cognitive and behavioural disorders, following traumatic brain injury TBI in chronic patients. - ND

FONDAZIONE SANTA LUCIA0 个研究点开始时间: 2007年4月12日最近更新: 2014年2月10日

适应症

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•Age between 18 and 55 years. Pathological performances in at least one test of the neuropsycological battery. 12 months minimum from traumatic brain injury. 12 weeks minimum between the last neuropsychological evaluation before the present study and the first experimental evaluation, in order to avoid learning effects
•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

•Severe upper limbs motor impairment which hampers the possibility of the neuropsychological evaluation Severe speech impairment which hampers the possibility of the neuropsychological evaluation Mini Mental State Examination MMSE lower than 14 Token Test score age and school corrected equal to 0 Previous traumatic brain injury Previous or in progress uncontrolled diabetes mellitus Previous or in progress chronic ostructive broncopneumopathology Delay in electric cardiac conduction Peptic ulcera in progress Positive family or personal anamnesis for glaucoma Positive personal anamnesis for alcoholism Positive personal anamnesis for drug use or abuse Uncontrolled epilepsy presence of crisis in the last 6 months Pregnancy Psychiatric pathology in Axis I of the DSM IV-R major psychiatric disorders Known cholinesterase inhibitors ipersensibility Actual assumption of anticholinergic, neuroleptics or benzodiazepine drugs Chronic post-traumatic amnesia PTA Galveston Orientation Amnesia Test lower or equal to 75 Patient inability to give his own informed consent. Pharmacologically uncontrolled severe arterious hypertention

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