Comparison of the effectiveness of transcranial magnetic stimulation (TMS) therapy with and without computer-based cognitive rehabilitation (CCR) in the brain signal of patients with bipolar disorder
The main aim of the present study is to investigate the effectiveness of computer based cognitive rehabilitation treatment with transcranial magnetic stimulation on cognitive functions, brain signals and symptoms of bipolar disorder.
Design
Clinical trial without control group, with two non-randomized groups and evaluation before and after treatment in 30 patients.
Settings and conduct
30 patients in Atieh Clinic in Tehran will be assigned to two groups. The first group receives bilateral rTMS for 20 sessions on right and left DLPFC; the second group receives the same rTMS protocol with 14 sessions of cognitive rehabilitation after that.
Participants/Inclusion and exclusion criteria
Outpatients male and female with the range of 18-65 years of age; the diagnosis of bipolar disorder according to DSM-V; having stable symptoms; completion of the consent form. Exclusion Criteria: The history of rTMS treatment; cardiac pacemaker; the risk of seizure with any reasons; pregnancy; intracranial implant.
Intervention groups
Two intervention groups; The first group will be treated with TMS and the second group will be treated with TMS and Computer based cognitive rehabilitation (TMS+CCR) at the same time
Main outcome variables
The Bipolar Depression Rating Scale (BDRS) score, Cognitive function (Assessment by Cantab Test), and The power of frequency bands in resting conditions and Changes in the P300 components in the Go-NoGo task (Brain signal recording with Mitsar device)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220321054335N1
Registration date:2022-10-29, 1401/08/07
Registration timing:retrospective
Last update:2022-10-29, 1401/08/07
Update count:0
Registration date
2022-10-29, 1401/08/07
Registrant information
Name
Haniyeh Ahmadi Segazi
Name of organization / entity
The University Of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 6519 7187
Email address
ahmadi.hanie@alumni.ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of transcranial magnetic stimulation (TMS) therapy with and without computer-based cognitive rehabilitation (CCR) in the brain signal of patients with bipolar disorder
Public title
Effect of rTMS with and without CCR in treatment of the bipolar disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All adults diagnosed with bipolar disorder by psychologists and psychiatrists
Minimum education in reading and writing
Exclusion criteria:
History of epilepsy or convulsions in the person or first degree relatives
Having acute heart disease
No history of drug use and head trauma
Pregnant or breastfeeding women
The presence of intracranial implants (such as shunts, electrodes) or any other metal object in or near the head (such as the mouth)
Having a pacemaker
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study,psychologists (evaluators), technicians, therapists (Health care personnel), and psychometricians will be blinded to the research design. In other words, the people referred to the evaluator or for treatment will be completely unaware that this person is part of a research project or a regular clinic patient.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Faculty of Psychology and Education
Street address
Dr. Kardan St., in front of Nasr Koi, Faculty of Psychology, University of Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۹۸۳۸۶۱
Approval date
2022-05-11, 1401/02/21
Ethics committee reference number
IR.UT.PSYEDU.REC.1401.026
Health conditions studied
1
Description of health condition studied
Bipolar Disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
The score of Bipolar Depression Rating Scale (BDRS)
Timepoint
Evaluation of mood symptoms before the start of the intervention and after the last session of TMS and CCR treatment.
Method of measurement
Bipolar Depression Rating Scale (BDRS)
2
Description
Evaluation of cognitive functions by Cantab
Timepoint
Evaluation of cognitive functions before the start of the intervention and after the last session of TMS and CCR treatment.
Method of measurement
the Cambridge Neuropsychological Test Automated Battery (CANTAB) will be used.
3
Description
Power of frequency bands in rest condition and changes of P300 component during Go-NoGo task (using Mitsar EEG recording device).
Timepoint
Evaluation of brain signal before the start of the intervention and after the last session of TMS and CCR treatment.
Method of measurement
by 19-channel EEG device during rest and Go-NoGo task
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Bilateral rTMS; The coil will locate on F3 and F4 in accordance with the 10-20 international system. Bilateral rTMS include stimulate the right DLPFC at 1 Hz for a 10 seconds train of stimulation, and a total of 900 pulse trains. Immediately after that, the stimulation was carried out on the left DLPFC at 10 Hz, 5 seconds of stimulation, with 10 second inter-train interval and 75 pulse trains
Category
Treatment - Other
2
Description
Intervention group: Bilateral rTMS with Cognitive rehabilitation therapy; In this group, the same TMS protocol as the first group will be used, and after a short break from the end of the TMS session, they will receive attention and memory exercises according to their level in about 45 minutes for 14 sessions using Rahacom rehabilitation software.
No. 628, Khazaei Alley, Shahid Sadoughi Street, Mallard Road, Tehran
City
Tehran
Province
Tehran
Postal code
3169467471
Phone
+98 21 6519 7187
Email
ahmadi.hanie123@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Atieh Clinical Neuroscience Center (ACNC)
Full name of responsible person
Haniyeh Ahmadi Segazi
Position
psychologist
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 628, Khazaei Alley, Shahid Sadoughi Street, Mallard Road, Tehran
City
Malard
Province
Tehran
Postal code
3169467471
Phone
+98 21 6519 7187
Email
ahmadi.hanie123@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
Yes - There is 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
All the initial and final evaluations of the treatment will be stored in Excel without the names of the participants.
When the data will become available and for how long
After the end of the study and the analysis of the results and the publication of the preliminary results (assuming about 6 months after the end of the study), it will be possible to request access to the data.
To whom data/document is available
Researchers in line with the research topic without restrictions
Under which criteria data/document could be used
In order to improve the treatment and the scientific field in question, all researchers can apply with a guarantee of trustworthiness.
From where data/document is obtainable
ahmadi.hanie@gmail.com
What processes are involved for a request to access data/document
In the form of an email, the type of data and documents expected and the reason for the request will be sent, and the researcher will send the information format.