The effect of donepezil on the persistent cognitive executive function deficit in traumatic brain injury patients
Design
The Phase 2 clinical trial consists of a group of 17 patients with traumatic brain injury
Settings and conduct
. Consecutive sampling will be done from all patients referred to the clinics of Guilan University of Medical Sciences who meet the inclusion criteria. Before the intervention, the patients' cognitive level is determined by the physician using the Persian version of MMSE. The Digital Signal-Stop Executive Function . In this experiment, the response time and accuracy of the response are measured.
Digital tests such as Tower of London test , Cambridge gambling test , continues performance test , lawton daily life activity test are performed at the baseline and end of the last treatment session.
Participants/Inclusion and exclusion criteria
Inclusion :Patients with all TBI intensities , age 18 to 60 years, , at least 4 years of study with formal education, MMSE score 17-23, 3 months after traumatic brain injury,.
Exclusion : history of neurological diseases , previous stroke, history of mental disorder and use of antipsychotic and antidepressant drugs, drug abuse while studying Or a few months ago, cognitive and verbal impairment before TBI and sensory deprivation such as deafness and blindness, , patient dissatisfaction with continuing to participate in the study
Intervention groups
An intervention group consisted of 17 patients receiving medication for 1 month
Main outcome variables
Cognitive dimensions and speed of information processing and executive functions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130416013027N4
Registration date:2020-08-17, 1399/05/27
Registration timing:retrospective
Last update:2020-08-17, 1399/05/27
Update count:0
Registration date
2020-08-17, 1399/05/27
Registrant information
Name
Sara Ramezani Kapourchali
Name of organization / entity
Guilan Road Trauma Research Centre
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 8373
Email address
s.ramezanislp@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-06, 1399/05/16
Expected recruitment end date
2020-08-16, 1399/05/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of donepezil on the persistent cognitive executive function deficit in traumatic brain injury patients
Public title
The effect of donepezil on the persistent cognitive executive function deficit in traumatic brain injury patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
17
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the fact that only one group of 17 people are included in the study, randomization is not performed
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Trauma research center, Poursina hospital, Namjoo ave
City
Rasht
Province
Guilan
Postal code
4193713194
Approval date
2020-07-29, 1399/05/08
Ethics committee reference number
IR.GUMS.REC.1399.217
Health conditions studied
1
Description of health condition studied
persistent cognitive executive function deficit in traumatic brain injury patients
ICD-10 code
S06
ICD-10 code description
Intracranial injury
Primary outcomes
1
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurosurgery Clinic of Poursina Hospital
Full name of responsible person
Zohair Reihanian
Street address
Parastar Ave, Poursina Hospital, Imam Reza Clinic
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3332 2444
Email
ali.shams@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohamadreza Naghi pour
Street address
Namjoo Ave, Shahid Siadati Street
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3333 5821
Email
naghi@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Zohair Reihanian
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Neurosurgery
Street address
Trauma research center, PourSina Hospital, Parastar Ave
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8773
Fax
Email
zoheir.reihanian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sara Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Trauma research center, PourSina Hospital, Parastar Ave
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8773
Email
s.ramezanislp@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Sara Ramezani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Trauma Research Center, PourSina Hospital, Parastar Ave
City
Rasht
Province
Guilan
Postal code
4193713194
Phone
+98 13 3336 8773
Email
s.ramezanislp@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some information related to main outcome are provided
When the data will become available and for how long
6 months after summary data published
To whom data/document is available
Only academic researchers
Under which criteria data/document could be used
For the therapeutic decision making in clinic
From where data/document is obtainable
s.ramezanislp@gmail.com
What processes are involved for a request to access data/document