Determining the extent of improvement of cognitive abilities and brain signals by stimulating extracranial direct current in patients with bipolar disorder and healthy individuals
Design
The present study is a clinical trial with pre-test, post-test and follow-up. The statistical sample of this study is 45 people and they will be randomly assigned to three groups of 15. Random allocation is done by dividing the participants into target groups
Settings and conduct
Location of Beheshti Hospital - non-identical examiner and therapist - pre-test, post-test and quarterly follow-up
Participants/Inclusion and exclusion criteria
Inclusion criteria are: 1_ having an age of at least 18 and a maximum of 65 years 2_ having a diagnosis of bipolar disorder type 1 3 - patients in the euthemic phase of their disorder 4 Drug use and dependence 2_ Having a history of neurological diseases 3_ Having a disease related to the scalp 4_ Having a history of head trauma 5_ Having a device or tool in the head
Intervention groups
Cranial direct current stimulation (tDCS) treatment program with electrodes 35 cm in size and 2 mA intensity for 10 sessions of 20 minutes in 3 consecutive weeks for two groups, the first group tDCS (anode in L-DLPFC, cathode in (L -TPC, the same protocol will be implemented in the second group (Sham-tDCS) for forty seconds. Also in the third group, which is healthy people, the same protocol will be performed in the experimental group. Run and after three months the same tools will be run again on the subjects
The effectiveness of transcranial direct current stimulation on neurocognition in patients with type 1 bipolar disorder.
Public title
Treatment of patients with type 1 bipolar disorder: clinical trial a double-blind study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a diagnosis of bipolar disorder type one
Being in the euthanic phase based on assessment
The same dose and medicine
Stabilization in medical treatment for at least 4 weeks
Stabilization of drug and medicine dose during research
Exclusion criteria:
Having drug use and dependence up to 6 months before treatment
Having a history of neurological diseases
Having diseases related to the scalp
Having a history of head injuries
The presence of a device or tool in the head
Exclude from the study after absence in two consecutive sessions of treatment
Being left-handed
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects are selected from purposive sampling method and using simple randomization method, based on which the subjects are assigned to the two groups of control and experiment by tossing coins.This method is used for two-group clinical trials, according to which one group is called a lion, and the other is called a line, and thus the number of coin samples is tossed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the clinical evaluator and therapist will be blind to assigning subjects to control and experimental groups. In addition, we use the clinical evaluator separately for baseline assessments and follow-up, and the therapist separately for treatment.Subjects will also be assigned to control groups or blind experiments, so that subjects will not meet outside of the sessions and will visit at times when no other subjects will be present.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Shahid Beheshti Hospital, Ark Gate, Saadi Crossroads, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
8431575143
Approval date
2022-05-02, 1401/02/12
Ethics committee reference number
IR.ZUMS.REC.1401.049
Health conditions studied
1
Description of health condition studied
Bipolar disorder type 1
ICD-10 code
اختلال دو
ICD-10 code description
F39
2
Description of health condition studied
Bipolar disorder type 1, mania, manic depression, bipolar depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Executive performance: Executive performance refers to the ability to integrate thought and action to achieve a goal
Timepoint
pre test_post test_3mounth follow up
Method of measurement
The score that a person gets from the second part of the sequence test
2
Description
Spatial visual memory: means the ability to store and manipulate information in consciousness for a short period of time
Timepoint
pre test_post test_3mounth follow up
Method of measurement
The score that a person gets from the test of complex images
3
Description
Delayed Recognition: The ability to retrieve specific information after a period of time or distraction
Timepoint
pre test_post test_3mounth follow up
Method of measurement
The score that a person gets from the test of complex images
Secondary outcomes
1
Description
Attention is a cognitive process in which the mind focuses on a specific stimulus or stimuli from the environment and other environmental stimuli are ignored.
Timepoint
pre test_post test_3mounth follow up
Method of measurement
The score that a person gets from the sequence test in the first part
Intervention groups
1
Description
Intervention group: Treatment with stimulation of transcranial direct current stimulation with a cintensity of 2 mA for 20 minutes on the lateral dorsal forehead cortex will receive 10 sessions of 20 minutes in 3 consecutive weeks.
Category
Treatment - Other
2
Description
Control group: Intervention group: Treatment with stimulation of transcranial direct current stimulation with a cintensity of 2 mA for 40 seconds on the lateral dorsal forehead cortex will receive 10 sessions of 20 minutes in 3 consecutive
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Educational and Medical Center in Zanjan
Full name of responsible person
Dear Dr. Ramin Maleki
Street address
Shahid Beheshti Hospital, Ark Gate, Saadi Crossroads, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
7531974143
Phone
+98 21 8670 5504
Email
farahnaz.yosefi76@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Parviz Ghezelbash
Street address
Zanjan University of Medical Sciences, Sabouti Blvd., Zanjan Province
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
40
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
Islamic Azad University
Full name of responsible person
Omidreza Heidari
Position
Teaching assistant
Latest degree
Bachelor
Other areas of specialty/work
Medical Engineering
Street address
Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
7531974143
Phone
+98 21 8670 5698
Email
omid.orh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farahnaz Yousefick[hk
Position
Master of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
7531974143
Phone
02445731
Email
farahnaz.yosefi76@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Farahnaz Yousefi
Position
کارشناس ارشد روانشناسی بالینی
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
City
zanjan
Province
Zanjan
Postal code
7531974143
Phone
02447185
Email
farahnaz.yosefi76@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
No - There is not 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
All information of individuals except names and confidential information will be published at the end of the research. Publishable information including: therapeutic changes, results of questionnaires, statistical results of signal analysis, dose and medication used
When the data will become available and for how long
The results of this research will be published three months after the end of the research
To whom data/document is available
All researchers, researchers, colleagues, and others
Under which criteria data/document could be used
To carry out similar projects and if all the material and intellectual rights of researchers are observed.
From where data/document is obtainable
Contact the following email address to receive the documentation: Farahnaz Yousefi Master of Clinical Psychology farahnaz.yosefi76@gmail.com Address: Beheshti Hospital, Ark Gate, Chahar Ra Saadi, Zanjan Province
What processes are involved for a request to access data/document
The data will be provided to the applicant after receiving the e-mail of the applicant and observing the material and intellectual rights of the researchers.