Investigating the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on treatments of symptoms attention deficit-hyperactivity disorder( ADHD) in adults aged 18-40
Investigation of the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) on the treatment of symptoms of hyperactivity and attention deficit in adults.
Design
A clinical trial without control group on 15 patients
Settings and conduct
The project is conducted on 15 patients at Tehran University of Medical Sciences, who are diagnosed by a skilled psychiatrist based on DSM-V criteria. After the clinical diagnosis, the patient is referred to the TMS unit for basic evaluations including (Conners Adult Scale (CAARS); General Clinical Evaluation CGI; Brown Attention Deficit Scale (BADDS)
Integrated Assessment of Visual and Auditory Assessment (IVA);Barkley Deficits in Executive Functioning Scale (BDEFS)
the patient's treatment sessions will be implemented during 3 weeks, which includes 15 rTMS sessions, which will be done 5 times a week. Then the above tests are taken again. The participants are followed up for one month, then they receive another rTMS session (session 16) and the tests are taken from the participants for the third time. The results of the basic data are compared after the 15th session and one month later (16th session).
Participants/Inclusion and exclusion criteria
Diagnosis of attention deficit hyperactivity disorder (ADHD) based on the diagnostic criteria ;that are between the ages of 18 and 40 years old ;They are no suffering from epilepsy and other major psychiatric disorders
Intervention groups
Repetitive transcranial magnetic stimulation(rTMS)will be performed on 15 patients during 3 weeks, which includes 15 treatment sessions that will be performed 5 times a week. The participants are followed for one month, then they receive another session.
Main outcome variables
Connors questionnaire score; Brown questionnaire score; IVA-2 questionnaire score; BDEF questionnaire score; CGI general clinical evaluation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240123060776N1
Registration date:2024-05-30, 1403/03/10
Registration timing:retrospective
Last update:2024-05-30, 1403/03/10
Update count:0
Registration date
2024-05-30, 1403/03/10
Registrant information
Name
Narges Karimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4444 7514
Email address
karimpournarges@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on treatments of symptoms attention deficit-hyperactivity disorder( ADHD) in adults aged 18-40
Public title
Ivestigating the effect of rTMS on adult ADHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 to 40
Ability to understand Persian language
Diagnosis of attention deficit hyperactivity disorder (ADHD) based on DSM5 diagnostic criteria
Informed consent of the individual
Exclusion criteria:
suffering from other psychiatric disorders except simple phobia and nicotine addiction, (psychiatric disorders including mood disorders (major depression or bipolar disorder), obsessive compulsive disorder, personality disorder (including antisocial), substance abuse) and psychosis
risk of serious suicide
taking antipsychotic, antidepressant or mood stabilizer drugs
A history of epilepsy in yourself or a first-degree relative
severe physical problems or neurological disorder
Taking drugs that lower the seizure threshold
The presence of a magnetic device or metal splinter in the head, and a cardiac pacemaker
pregnancy
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group/Ethics Committee in Research Faculty of Medicine - Tehran University of Medical Scienc
Street address
Rozbeh Hospital , below Lashgar intersection,1ضشSouth Kargar St.
To evaluate the clinical symptoms of hyperactivity, Connors questionnaire score, Brown questionnaire score ;Clinical global impression
Timepoint
before the start of the study (week=0)and three weeks after (week=3)and seven weeks after(week=7) the start of the intervention
Method of measurement
Connors questionnaire score, Brown questionnaire score ;Clinical global impression
2
Description
attention deficit
Timepoint
before the start of the study (week=0)and three weeks after (week=3)and seven weeks after(week=7) the start of the intervention
Method of measurement
Connors questionnaire score, Brown questionnaire score ;Clinical global impression
3
Description
Accuracy and error in auditory and visual attention
Timepoint
before the start of the study (week=0)and three weeks after (week=3)and seven weeks after(week=7) the start of the intervention
Method of measurement
Integrated visual and auditory assessment (IVA-2) which is a Computer test
Secondary outcomes
1
Description
Symptoms related to defects in executive functions
Timepoint
before the start of the study (week=0)and three weeks after (week=3)and seven weeks after(week=7) the start of the intervention
Method of measurement
Barkley Deficits in Executive Functioning Scale
Intervention groups
1
Description
Intervention group: rTMS intervention will be in the form of 120% motor threshold on the right frontal cortex, or 18 Hz stimulation frequency, including 40 trains, for 2 seconds, with an interval of 20 seconds, (a total of 1440 pulses per session). The patient will be treated during 3 weeks, which includes 15 treatment sessions, which will be done 5 times a week. The participants will be followed up for one month, then they will receive another rTMS session (16 sessions).
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Javad Alaghband-rad
Street address
South Kargar Ave
City
Tehran
Province
Tehran
Postal code
1337159140
Phone
+98 21 5541 2200
Email
jalaghbandrad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Central Organization of the University, 6th floor of Research and Technology Vice-Chancellor ,Qods st, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3658
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Javad Alaghband-rad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh hospital. South kargar
City
Tehran
Province
Tehran
Postal code
1337159140
Phone
009855419151
Email
jalaghbandrad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Javad Alaghband-rad
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Roozbeh hospital. South kargar
City
Tehran
Province
Tehran
Postal code
1337159140
Phone
009855419151
Email
jalaghbandrad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narges karimpour
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
South Kargar
City
Tehran
Province
Tehran
Postal code
1337159140
Phone
+98 21 5541 9151
Email
karimpournarges@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after de-identification
When the data will become available and for how long
The data can be made available 6 months after the results are published
To whom data/document is available
Researchers in academic and scientific institutions can access the data
Under which criteria data/document could be used
Data can be used for meta-analyses if needed. It is necessary to mention the names of the main researchers of this research.
From where data/document is obtainable
In case of data request, write to jalaghbandrad@gmail.com.
What processes are involved for a request to access data/document
After receiving the request and its review by the main researcher, the data will be sent to the applicant along with a letter of commitment stating that the data will not be published without the name of the main researcher within one month