The present study seeks to investigate high definition-transcranial direct-current stimulation (HD-tDCS) on cognitive and depression symptoms of the elderly.
Design
This is a clinical trial research with pre-test, post-test, one-month follow-up and control group. There are parallel groups of 30 participants that We will randomly divide the clients into two groups (experimental and control).
Settings and conduct
This is a randomized clinical trial study in which the double blind method will be used. Therefore we refer to Shiraz geriatric research center and by using the convenience sampling method, people with discomfort and complaints of depression are suggested to participate in the study. We offer neurotherapy to satisfy the clients to participate in the research.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of the disorder by a psychiatrist, Rejecting differential diagnosis by a neurologist, Aged between 50 to 75 years, Not suffering from cardiovascular disease and diabetes, Not Smoking. Exclusion criteria: Dissatisfaction to participate in the research, Having a type of motor or cognitive disabilities, Receiving simultaneous psychiatric treatment, History of seizure disorders, Having a pacemaker.
Intervention groups
The intervention group received high definition-transcranial direct-current stimulation (HD-tDCS) at 2 mA (positive stimulation) over 10 consecutive sessions. Ten sessions of HD-tDCS without electricity flow (sham mode) will be used for the control group.
Main outcome variables
Cognitive Symptoms, Depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190708044138N2
Registration date:2020-05-18, 1399/02/29
Registration timing:registered_while_recruiting
Last update:2020-05-18, 1399/02/29
Update count:0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Mohammad Hossein Sorbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3621 1306
Email address
sorbih@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-12, 1398/08/21
Expected recruitment end date
2020-08-10, 1399/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of High Definition-transcranial Direct Current Stimulation (HD-tDCS) on Cognitive Problems and Mood of Shiraz Elderly
Public title
Effectiveness of High Definition-transcranial Direct Current Stimulation (HD-tDCS) on the mental health of elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Gaining mild to moderate depression score (scores from 14to 30) in the Beck depression inventory
Rejecting differential diagnosis of neuro-motor disorder by a neurologist and absence of neurological disorder
Aged between 50 to 75 years
Not suffering from cardiovascular disease, kidney disease and diabetes (getting information by asking from participants and get help from a physician)
Not Smoking and not taking painkillers, sedatives and hypnotics.
Exclusion criteria:
Dissatisfaction to participate in the research
Having a type of motor or cognitive disabilities that interferes working with computer
Receiving simultaneous psychiatric treatment or other psychotherapies to relieve depression disorder
History of seizure disorders in individuals
having a pacemaker, having a metal object in the head and neck or any other obstacle to do electrical stimulation
Age
From 50 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using www.randomization.com to assign equal participants in each group (1:1 allocation ). An independent researcher will make random allocation cards using computer-generated random numbers. he will keep the original random allocation sequences until analysis time. Another researcher will measure the patients outcome and he will not know the allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The neuroscientist of geriatric research center will be aware of the research topic and will perform therapeutic interventions. He codes the patients and refers them to a psychologist to check the patient's mental state and record the relevant criteria based on the same code. The patients will be tested in the same condition in the neurotherapy room and the electrodes of the device will be connected to their, but they will not be aware of the real or sham stimulation. Accordingly, this study will be a double-blind study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Zand St, Central building of Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2019-08-07, 1398/05/16
Ethics committee reference number
IR.SUMS.REC.1398.746
Health conditions studied
1
Description of health condition studied
Major depressive disorder, single episode, moderate
ICD-10 code
F32.1
ICD-10 code description
Major depressive disorder, single episode, moderate
Primary outcomes
1
Description
Cognitive Symptoms
Timepoint
Cognitive Symptoms was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session.
Method of measurement
The Integrated Visual and Auditory (IVA-2)
2
Description
Depression
Timepoint
Depression was measured at the beginning of the study (before the intervention), after the last treatment session, and 30 days (one month) after the last treatment session.
Method of measurement
Beck depression inventory (BDI-II)
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group received high definition-transcranial direct current stimulation (HD-tDCS) at 2 mA (positive or anode stimulation) over 10 consecutive sessions (25 minutes per session)
Category
Treatment - Devices
2
Description
The control group received high definition-transcranial direct current stimulation (HD-tDCS) with sham mode over 10 consecutive sessions.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Geriatric Research Center
Full name of responsible person
Dr. Mohammad Ali Nazarinia
Street address
Zand St, Shiraz Geriatric Research Center, Shiraz University of Medical Science
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3612 2203
Email
nazariniam@sums.ac.ir
Web page address
http://sgrc.sums.ac.ir/en/index.html
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Zand St, Central building of Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2884
Email
gsia@sums.ac.ir
Web page address
https://www.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Urmia University
Full name of responsible person
Mohammad Hossein Sorbi
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Eleven kilometers of University Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
+98 44 3275 2741
Email
Sorbih@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Ali Nazarinia
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Zand St, Shiraz Geriatric Research Center
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2283
Email
nazariniam@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Urmia University
Full name of responsible person
Mohammad Hossein Sorbi
Position
Instructor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Eleven kilometers of University Boulevard
City
Urmia
Province
West Azarbaijan
Postal code
5756151818
Phone
009832752741
Email
Sorbih@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not 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
Participant Data File: Because the individual data of the study participants are considered, this study shares some of the data such as information about the main outcomes of the study.
When the data will become available and for how long
The access period starts 9 months after the results are published.
To whom data/document is available
The data obtained from this study are only available to researchers working at Urmia University snd Shiraz University of Medical Sciences.
Under which criteria data/document could be used
The data of this research are only permitted for review and meta-analysis studies.
From where data/document is obtainable
Visit Mr. Mohammad Hossein Sorbi from Urmia University, or contact him by email or phone. Phone: 09131560290, Email: Sorbih@gmail.com
What processes are involved for a request to access data/document
Applicants are required to submit a written request to Mr. Sorbi by email (9 months after the publication of the research results). After reviewing the request, the data will be sent to the applicant online via email.