Protocol summary

Summary
Objectives: To assess the effect of transcranial direct current stimulation versus no stimulation on working memory in elders with normal cognitive status Design: a double blind randomized clinical trial. Setting and conduct: The eligible elders who will refer to School of Public Health, Zahedan University of Medical Sciences, during the study period will be enrolled into the trial. Inclusion criteria: (a) age above 60 years; (b) score of MMSE less than 25. Exclusion criteria: (a) psychological disorders such as schizophrenia, mood disorder, dementia, active psychosis, and stimulant dependent; (b) neurological disorders involving central nerves system such as Alzheimer, Parkinson, stroke, multiple sclerosis; (c) chronic diseases such as diabetes, renal failure, lever failure, and hypo-thyroiditis; (d) history of head trauma during past six months. Intervention group: Andean stimulate of the left prefrontal skull with amperage 2 mA for 20 minutes daily for 5 days. Control group: Virtual stimulate of the left prefrontal skull for 20 minutes daily for 5 days. Primary outcome: Assessing the working memory using n-back test before intervention, before the third stimulation, the day after completion of stimulation and 2 week after intervention; (b) Assessing the verbal working memory using Digit span test before intervention, before the third stimulation, the day after completion of stimulation and 2 week after intervention. Secondary outcome: assessing cognitive impairment using MMSE questionnaire before intervention and 2 weeks after intervention. Randomization: Random assignment of the patients to the intervention and control groups using drawing lots. Blinding: Patients will be unaware of the type of stimulation. The examiner will not be aware of the stimulation. Therefore, the trial will be run as triple blind.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201605299014N101
Registration date: 2016-06-05, 1395/03/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-05, 1395/03/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Zahedan University of Medical Sciences
Expected recruitment start date
2016-01-05, 1394/10/15
Expected recruitment end date
2016-12-05, 1395/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of transcranial direct current stimulation versus no stimulation on working memory in elders with normal cognitive status: a double blind randomized clinical trial
Public title
Effect of transcranial direct current stimulation versus no stimulation on working memory in elders with normal cognitive status
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age above 60 years; (b) score of MMSE less than 25. Exclusion criteria: (a) psychological disorders such as schizophrenia, mood disorder, dementia, active psychosis, and stimulant dependent; (b) neurological disorders involving central nerves system such as Alzheimer, Parkinson, stroke, multiple sclerosis; (c) chronic diseases such as diabetes, renal failure, lever failure, and hypo-thyroiditis; (d) history of head trauma during past six months.
Age
From 60 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: Random assignment of the patients to the intervention and control groups using drawing lots. Blinding: Patients will be unaware of the type of stimulation. The examiner will not be aware of the stimulation. Therefore, the trial will be run as triple blind.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zahedan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Zahedan University of Medical Sciences, University Ave. Zahedan
City
Zahedan
Postal code
Approval date
2015-12-08, 1394/09/17
Ethics committee reference number
IR.ZAUMS.REC.1394.273

Health conditions studied

1

Description of health condition studied
Working memory
ICD-10 code
R41
ICD-10 code description
Other symptoms and signs involving cognitive functions and awareness

Primary outcomes

1

Description
Assessing the working memory
Timepoint
before intervention, before the third stimulation, the day after completion of stimulation and 2 week after intervention
Method of measurement
using n-back test

2

Description
Assessing the verbal working memory
Timepoint
before intervention, before the third stimulation, the day after completion of stimulation and 2 week after intervention
Method of measurement
using Digit span test

Secondary outcomes

1

Description
assessing cognitive impairment
Timepoint
before intervention and 2 weeks after intervention
Method of measurement
using MMSE questionnaire

Intervention groups

1

Description
Andean stimulate of the left prefrontal skull with amperage 2 mA for 20 minutes daily for 5 days.
Category
Treatment - Devices

2

Description
Virtual stimulate of the left prefrontal skull for 20 minutes daily for 5 days
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Public Health
Full name of responsible person
Dr Mona Kamali
Street address
School of Public Health, Health Ave.
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Zahedan University of Medical Sciences
Full name of responsible person
Dr Hooshang Rafighdoost
Street address
Zahedan University of Medical Sciences, University Ave.
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Zahedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Dr Mona Kamali
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
School of Public Health, Health Ave.
City
Zahedan
Postal code
Phone
+98 54 3329 5796
Fax
Email
kamali.m40@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health
Full name of responsible person
Dr Mahboobeh Firoozkoohi Moghadam
Position
Infant Psychiatrist
Other areas of specialty/work
Street address
School of Public Health, Health Ave.
City
Zahedan
Postal code
Phone
+98 543430543
Fax
Email
firoozkoohi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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