Determining the effectiveness of Transcranial Direct Current Stimulation on Working memory and narrative discourse of healthy elderly
.
Design
A clinical trial with a control group and an intervention group and a single-blind randomized trial is conducted on 36 people.
Settings and conduct
This study is conducted in Hamedan Ba'ath Hospital in a one-sided blind way on 36 healthy elderly people randomly with a control group.
Participants/Inclusion and exclusion criteria
Elderly people (60-85 years old) and Persian language should prevail.
Based on the Edinburgh test, it should be dominant in right-handed people.
The presence of a history of low vision and hearing loss is checked based on observation and interview with the patient's companions. If the visual and hearing impairment is to the extent that it cannot be compensated by auxiliary devices (glasses and hearing aids), the person will not be included in the study.
The person's cognitive status and intelligence based on the MMSE test should be normal. (Score 24 and above.)
Based on the examination of the medical record, they do not have a history of neurological and psychiatric diseases and speech and language.
No dependence on alcohol and drugs.
Not using drugs that affect the nervous system (such as antidepressants and sleeping pills)
Absence of any type of obstacle for the operation of the tDCS device, such as the presence of certain metals
Intervention groups
Intervention group: 18 healthy elderly people are subjected to brain stimulation for 20 minutes and in 5 days with a transcranial brain stimulation device and at the same time they perform the N-back test with a computer. The intensity of the stimulation with the device is 2 milliamperes.
Main outcome variables
Working memory and narrative discourse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230919059470N1
Registration date:2023-10-07, 1402/07/15
Registration timing:registered_while_recruiting
Last update:2023-10-07, 1402/07/15
Update count:0
Registration date
2023-10-07, 1402/07/15
Registrant information
Name
Ali Moshtagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4263 1318
Email address
ali.moshtagh.96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-02, 1402/07/10
Expected recruitment end date
2023-12-31, 1402/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of Transcranial direct current stimulation (tDCS) on the working memory and narrative discourse of healthy elderly
Public title
Investigating the effectiveness of Transcranial direct current stimulation (tDCS) on the working memory and narrative discourse of healthy elderly
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly people (60-85 years old) and Persian language should prevail.
Based on the Edinburgh test, it should be dominant in right-handed people.
Do not have irreparable visual or auditory sensory defects, that is, at a comfortable listening level (20 to 45 dB with hearing aids) and the vision can understand the message. The presence of a history of low vision and hearing loss is checked based on observation and interview with the patient's companions. If the visual and hearing impairment is to the extent that it cannot be compensated by auxiliary devices (glasses and hearing aids), the person will not be included in the study.
The person's cognitive status and intelligence based on the MMSE test should be normal. (Score 24 and above.)
Based on the examination of the medical record, they do not have a history of neurological and psychiatric diseases and speech and language.
No dependence on alcohol and drugs.
Not using drugs that affect the nervous system (such as antidepressants and sleeping pills)
Absence of any type of obstacle for the operation of the tDCS device, such as the presence of certain metals
Exclusion criteria:
Age
From 60 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Each person will be placed in two test (A) or control (B) groups using the random block method. The division of people into the test group or the control group will be done using blocks of 4 and the random replacement method, as follows (where A represents the test person and B represents the control person) and the allocation sequence will be determined.
ABBABABABAABABABBAABBBAABAABBAABABABAB
The type of intervention based on the predetermined sequence is written inside the envelopes in the opaque package and the envelopes will be numbered in order. After having the necessary conditions and willingness to participate in the study, each person will receive an envelope and the researcher will act based on the content inside the envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
The subjects of the study group are treated in the intervention process in each session by placing the anode electrode on the F3 area of the brain and with an intensity of 2 milliampers. The cathode electrode is placed in the right upper orbital region of the person. In the control group, the electrodes are placed in the desired areas, but after 1 minute and after reaching the intensity of 1 milliamperes, the device is automatically cut off, but the person is not aware and the sham stimulation conditions continue. It should be noted that none of the participants will be informed about the type of real and sham stimulation session.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
5th floor, Central Headquarters of University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.UMSHA.REC.1402.395
Health conditions studied
1
Description of health condition studied
working memory and narrative discourse of healthy elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Working memory
Timepoint
at the beginning of the study (before the start of the intervention) and after the end of the study (after the last day of the intervention) and 1 month after the end of the intervention
Method of measurement
N-back test
2
Description
narrative discourse
Timepoint
at the beginning of the study (before the start of the intervention) and after the end of the study (after the last day of the intervention) and 1 month after the end of the intervention
Method of measurement
Persian narrative discourse evaluation test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 18 healthy elderly people are subjected to brain stimulation for 20 minutes and in 5 days with a transcranial brain stimulation device and at the same time they perform the N-back test with a computer. The intensity of the stimulation with the device is 2 milliamperes.
Category
Rehabilitation
2
Description
Control group: 18 healthy elderly people are subjected to brain stimulation for 20 minutes and in 5 days with a transcranial brain stimulation device and at the same time they perform the N-back test with a computer. When the intensity of 1 milliampere is reached, the device is cut off.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Iraj sedighi
Street address
Shahid Beheshti Blvd, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3264 0020
Email
Besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza shokoohi
Street address
5th floor, Central Headquarters of University of Medical Sciences, Shahid Fahmideh Blvd., Hamadan, Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 4058
Email
shokoohi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Bahare rezai
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Speech therapy
Street address
Faculty of Rehabilitation Sciences, Hamadan University of Medical Sciences, Shahid Fahideh St., Hamadan
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۸۷
Phone
+98 81 3838 1571
Email
rezaeibahareh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Moshtagh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Ramdasht
City
Roudsar
Province
Guilan
Postal code
4481889363
Phone
+98 13 4263 1318
Fax
Email
Ali.moshtagh.96@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Ali Moshtagh
Position
Student of Master science
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
Ramdasht
City
Roudsar
Province
Guilan
Postal code
4481889363
Phone
+98 13 4263 1318
Fax
Email
Ali.moshtagh.96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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