Traumatic brain injury. other disorders of brain in diseases classified elsewhere
Conditions
Interventions
Intervention 1: Drug intervention of Donepezil without Memantine in dosage of 5 mg during 1 month then induction of drug dosage to 10 mg for 2 months . in first 1 month for Donepezil group one table
Treatment - Drugs
Placebo
Drug intervention of Donepezil without Memantine in dosage of 5 mg during 1 month then induction of drug dosage to 10 mg for 2 months . in first 1 month for Donepezil group one tablet of 5 mg Donepe
Drug intervention of Donepezil with Memantine carries out in dosage of 5 mg for each of them during 1 month then will be continued by induction of drug dosage to 10 mg for 2 months. In combined group
Control group receive placebo similar to Memantin and Donepezil. in first 1 month one and half tablet of placebo is used daily(one tablet of Donepezil placebo and half tablet of Memantine placebo at
Sponsors
Research adjutancy ,Guilan university of medical sciences
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: aphasia patients having post-traumatic cognitive deficit; moderate & severe traumatic brain injury according to GCS at first 24 h; age range between 18-60 years; GOS score 4 & 5; at least 4 years formal education; maximum of aphasia quotient 75 based on P.AD; moderate and severe cognitive deficit(MMSE score<17); post onset discharge time 2-4 weeks(sub-acute phase). Exclusion criteria: history of neurological disease including CVA, brain tumor, epilepsy, seizure, Parkinson and dementia...; previous brain trauma; history of psychiatric disorder and using of antipsychotic & antidepressant drugs; history of drug abuse and pre-existing verbal and cognitive deficit; exist of deafness and blindness; appearance of drug's side effects; exist of renal disease, heart disease, hypertension and unwillingness for continue of the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disability rate. Timepoint: before of intervention and 3 months after intervention onset. Method of measurement: disability rate scale (DRS).;Aphasia quotient. Timepoint: befor of intervention and 3 months after intervention onset. Method of measurement: Persian. aphasia diagnosis (P.AD).;Cognitive function. Timepoint: before of intervention and 3 month after intervention onset. Method of measurement: mini-mental state examination(MMSE). | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects of drugs. Timepoint: 1 month and 3 months after intervention onset. Method of measurement: observation and examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Sara Ramezani
Guilan Road trauma research center, Rasht, Guilan university of medical sciences
Outcome results
None listed