studying the effectiveness of working memory training in Alzheimer patients
Design
A randomised clinical trial with a parallel group design and 20 patients enrolled in julay 2019
Settings and conduct
research is conducted under supervision of a neurologist in his clinic.participants are put in experimental or control group by flipping a coin. according to subject's health status the training take place in their home.the executor shows and play the game in her laptop and trains patients
Participants/Inclusion and exclusion criteria
Inclusion criteria:
having Alzheimer,
being right handed,
being over 50 years old,
having normal vision.
Exclusion criteria:
stroke,
Epilepsy,
having any kind of neurodegenerative disease,
use of psychiatric medicine
Intervention groups
participants in the training group attend 12 sessions(30 minutes each).the sessions take place 3 days a week for 4 weeks in row.The subject is presented with a sequence of stimuli and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence.The load factor n can be adjusted to make the task more or less difficult.the visual n-back test is similar to the "concentration game" but instead of different items that are in a fixed location, there is only 1 item that appears in different positions.subject must remember if the current location of item matches with n step earlier in the sequence."N-1" means you must remember the position of the item,1 turn back.if the score of subject is more than 75% he/she goes to next n-back level.if the score is between 50%-75% he/she remains the current level and if the score is less than 50% he/she goes 1 level back.control group wont practice any memory training between pretest and post-test
The effectiveness of working memory training on brain waves changes in early stage of Alzheimer disease
Public title
The effectiveness of working memory training in Alzheimer disease.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Alzheimer patients which are in the early stage of their disease
participants are right hand
participants have normal vision
being over 50 years old
Exclusion criteria:
Epilepsy,
use of psychiatric medication
any kind of degenerative neurological pathway
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
patients will be subdivided into intervention and control groups by flipping a coin (simple individual randomization)
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahid Bahonar University of Medical Science
Street address
Shahid Bahonar University., Pajoohesh Sq., Kerman
City
Kerman
Province
Kerman
Postal code
76169-14111
Approval date
2019-08-25, 1398/06/03
Ethics committee reference number
IR.KMU.REC.1398.279
Health conditions studied
1
Description of health condition studied
Alzeimer
ICD-10 code
G30
ICD-10 code description
Alzheimer's disease
Primary outcomes
1
Description
Alpha peak
Timepoint
3 day before and 3 day after the intervention
Method of measurement
electroencephalograph
2
Description
alpha absolute power
Timepoint
3 day before and 3 day after the intervention
Method of measurement
electroencephalograph
3
Description
relative Alpha power
Timepoint
3 day before and 3 day after the intervention
Method of measurement
electroencephalograph
4
Description
beta absolute power
Timepoint
3 day before and 3 day after the intervention
Method of measurement
electroencephalograph
5
Description
relative beta power
Timepoint
3 day before and 3 day after the intervention
Method of measurement
electroencephalograph
6
Description
working memory
Timepoint
3 day before and 3 day after the intervention
Method of measurement
digit span questionare
7
Description
Severity of dementia
Timepoint
3 day before and 3 day after the intervention
Method of measurement
mini-mental status examination test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: participants in the training group attend 12 sessions (30 minutes each). the sessions take place 3 days a week for 4 weeks in row (in another words for 1 month). The subject is presented with a sequence of stimuli, and the task consists of indicating when the current stimulus matches the one from n steps earlier in the sequence. The load factor n can be adjusted to make the task more or less difficult.To clarify, the visual n-back test is similar to the classic memory game of "Concentration". However, instead of different items that are in a fixed location on the game board, there is only one item, that appears in different positions on the game board during each turn and subject must remember if the current location of item matches with n step earlier in the sequence. "N-1" means that you have to remember the position of the item, one turn back. "N-2" means that you have to remember the position of the item two turns back, and so on. if the score of subject is more than 75% he or she will go to next n-back level. if the score is between 50%-75% he/she remain the current level. and if the score is less than 50% he/she will go one level back.
Category
Treatment - Devices
2
Description
Control group: the control group is not under any intervention or treatment.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Neuroscience Center
Full name of responsible person
Doctor Hosein-ali Ebrahimi meimand
Street address
No.1 Jahad ave., - infront of Besat clinic
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 4198
Email
hebrahimi@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Reza Dehnavi
Street address
Kerman University of Medical Sciences,Medical University Campus,Haft-Bagh Highway, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
13555-76169
Phone
+98 34 3132 5402
Email
rdehnavi@gmail.com
Web page address
http://futures.kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Hosein-ali Ebrahimi meimand
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Center of Brain Disease Research., Shafa hospital., Kosar ave,. Kerman
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3212 4727
Email
hebrahimi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hosein Ali Ebrahimi
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Neuroscience
Street address
Center of Neurology Research , Shafa Hospital,. Kosar ave.
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۱۱۵۱
Phone
+98 34 2345 3032
Email
hebrahimi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Pegah Dehghan
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Shahid Bahonar University.; Pajoohesh Sq
City
Kerman
Province
Kerman
Postal code
76169-14111
Phone
+98 34 3132 3066
Email
pegah.dehghan14@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
the data about main consequence (dependent variables) will be shared
When the data will become available and for how long
6 Month after the conclusion get published
To whom data/document is available
limitless
Under which criteria data/document could be used
there is no limit
From where data/document is obtainable
email: pegah.dehghan14@gmail.com
It will be also published as a thesis and will be available in library of Shahid Bahonar University
What processes are involved for a request to access data/document
first the responsible of research must approve the request.then data will be sent.