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IRCT20130416013027N4 IRCT 2020-08-17 Rasht University of Medical Sciences The effect of donepezil on the persistent cognitive executive function deficit in traumatic brain injury patients The effect of donepezil on the persistent cognitive executive function deficit in traumatic brain injury patients 2020-08-06 anticipated 17 Complete https://irct.ir/trial/50017 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: Due to the fact that only one group of 17 people are included in the study, randomization is not performed. 2 persistent cognitive executive function deficit in traumatic brain injury patients. Intervention group: It consists of 17 people who, after performing baseline examinations and recording their results, are prescribed ِDonepezil 5 mg daily for the first week, 10 mg daily for the next 3 weeks.. Yes - There is a plan to make this available What will be shared: Some information related to main outcome are provided When: 6 months after summary data published To whom: Only academic researchers Conditions: For the therapeutic decision making in clinic Where to obtain: s.ramezanislp@gmail.com How to obtain: Between 1 to 2 month after request Comments:
public Zohair Reihanian
Trauma research center, PourSina Hospital, Parastar Ave
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8773 zoheir.reihanian@gmail.com Rasht University of Medical Sciences scientific Sara Ramezani
Trauma research center, PourSina Hospital, Parastar Ave
Rasht Iran (Islamic Republic of) 4193713194 +98 13 3336 8773 s.ramezanislp@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with all severities of TBI Patients aged 18 to 60 years Patients with GOS 4 and 5 Consciousness level of10 to 15 At leaast 4 years of formal education MMSE score between 17-23 At least 3 months after discharge from hospital due to TBI 18 years 60 years Both History of neurological diseases History of mental disorder and use of antipsychotic and antidepressant drugs, drug abuse while studying or last few months Cognitive and verbal disorders before TBI and sensory deprivations such as deafness and blindness, clinical instability or behavioral problems that prevent the subject from participating in the intervention Patient dissatisfaction with continuing to participate in the study S06 Intracranial injury Treatment - Drugs Intervention group: It consists of 17 people who, after performing baseline examinations and recording their results, are prescribed ِDonepezil 5 mg daily for the first week, 10 mg daily for the next 3 weeks. Cognitive executive function deficit. Timepoint: Before starting study and one month after starting study. Method of measurement: Before the intervention, the patients' cognitive level is determined by the physician using the Persian version of MMSE. The Digital Signal-Stop Executive Function Test Form is used to assess inhibitory control and executive function and information processing speed . In this test, the response time and accuracy of the response are measured. Digital tests to measure cognitive dimensions and information processing speed and performance, such as the Tower of London test (TLT), Cambridge gambling test (CGT), continuing performance test (CPT), lawton daily life activity test (IADL) are performed at the beginning and the end of the last treatment session. Rasht University of Medical Sciences Approved 2020-07-29 Guilan University of Medical Sciences Trauma research center, Poursina hospital, Namjoo ave Rasht Guilan Iran (Islamic Republic of)