Assessment the efficacy of intermittent theta-burst stimulation to improve the symptoms of patients with ASD
Design
A randomized wait-list control trial with a sample size of 28 subjects and equal allocation between groups.
Randomization will be based on the random allocation rule.
Settings and conduct
The study population will be included the children who met the Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria for diagnosis of ASD. Eligible individuals are divided into two groups of experimental and waiting list. Interventions are performed by 2 trained technicians in Rad Clinic in Tehran and Dr. Hosseini's office in Sari. This study is not blinded. Patients will be evaluated before the intervention, immediately and one months after the end of the sessions by four psychometric instruments.
Participants/Inclusion and exclusion criteria
Inclusion criteria;
1)Autism Spectrum Disorder (ASD) in the age group of 9 to 17 years
2)Mild to moderate ASD
3) Stable clinical condition in the last 2 months
4) Stable treatment schedule in the last 2 months
5) Intelligence quotient of 55 or greater on the Wechsler test
Criteria for non-inclusion in the study;
1)Severe ASD
2) Intelligence quotient less than 55 on the Wechsler test
3) History of seizures
4) History of serious head trauma
5) The presence of implants in the brain
6) History of substance abuse
Intervention groups
The experimental group will receive 15 sessions of intermittent theta-burst stimulation over the right dorsolateral prefrontal cortex and in the control group no intervention will be used.
Main outcome variables
Severity of Autism spectrum disorder symptoms based on Autism Behavior Checklist;
Severity of obsessive compulsive symptoms based on score of Yale-Brown Obsessive Compulsive Scale;
Selective attention based on Stroop test;
Executive function based on Wisconsin Card Sorting test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220204053933N1
Registration date:2022-03-13, 1400/12/22
Registration timing:registered_while_recruiting
Last update:2022-03-13, 1400/12/22
Update count:0
Registration date
2022-03-13, 1400/12/22
Registrant information
Name
Seyede Hakime Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 1811
Email address
s.hakime.hashemi64@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-05, 1400/12/14
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intermittent theta-burst trans-cranial magnetic stimulation for autism spectrum disorder: A randomized Controlled Trial
Public title
Intermittent theta-burst stimulation for autism spectrum disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with autism spectrum disorder (ASD) aged 9 to 17 years
Mild to moderate ASD
Stable clinical conditions in the last 2 months
Stable treatment schedule in the last 2 months
Intelligence quotient of 55 or greater on the Wechsler test
Exclusion criteria:
Patients with severe ASD
Intelligence quotient <55 based on Wechsler intelligence test
History of seizures
History of serious head trauma
The presence of implants in the brain
History of substance abuse
Age
From 9 years old to 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be performed.
Before the study, 28 sealed envelopes containing treatment information (test or waiting list, with equal allocation) were prepared, and after the start of the study, they were randomly selected for each participant.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
13th floor,Block A, Ministry of Health and Medical Education, Simaye Iran Street, Qods Town, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2021-09-08, 1400/06/17
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.634
Health conditions studied
1
Description of health condition studied
Autism Spectrum Disorder
ICD-10 code
F84.0
ICD-10 code description
Autistic disorder
Primary outcomes
1
Description
Severity of Autism Spectrum Disorder Symptoms Based on Autism Behavior Checklist
Timepoint
Evaluation before the intervention, immediately after the end of 15 sessions, one month after the end of the sessions
Method of measurement
Autism Behavior Checklist
2
Description
Severity of obsessive-compulsive symptoms based on score of Yale-Brown Obsessive Compulsive Scale (YBOCS)
Timepoint
Evaluation before the intervention, immediately after the end of 15 sessions, one month after the end of the sessions
Method of measurement
Yale-Brown Obsessive Compulsive Scale (YBOCS)
3
Description
Changes in selective attention based on Stroop test
Timepoint
Evaluation before the intervention, immediately after the end of 15 sessions, one month after the end of the sessions
Method of measurement
Stroop test
4
Description
Change in executive function based on Wisconsin Card Sorting Test
Timepoint
Evaluation before the intervention, immediately after the end of 15 sessions, one month after the end of the sessions
Method of measurement
Wisconsin Card Sorting Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 15 theta burst stimulation sessions (one session per day for 3 consecutive weeks) will be conducted for each participant in the intervention group. In this study, electromagnetic excitations on the right dorsolateral prefrontal cortex will be considered. Theta-burst stimulation parameters include: Burst pattern: three pulses delivered at 50Hz Train duration: bursts repeated five times per second (5Hz) for 2s (10 bursts). Intensity: 100% of resting motor threshold. Inter-train interval: 8s. Total time: 300s Total trains: 30. Total bursts: 300. Total pulses: 600
Category
Treatment - Devices
2
Description
Control group: The control group did not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Seyede Hakime Hashemi
Street address
South Kargar Street
City
Tehran
Province
Tehran
Postal code
13337159140
Phone
+98 21 5541 2244
Email
hosp_roozbeh@tums.ac.com
Web page address
https://roozbehhospital.tums.ac.ir/public/en
2
Recruitment center
Name of recruitment center
Dr. Seyed Hamzeh Hosseini's office
Full name of responsible person
Seyede Hakime Hashemi
Street address
Berlian Medical Complex, Upper floor of Tejarat Bank, Imam Square
City
Sari
Province
Mazandaran
Postal code
4815715945
Phone
+98 11 3336 9323
Email
Hosseinish20@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Sixth floor, Vice Chancellor for Research and Technology, University Central Organization, Qods St., Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Web page address
https://vcr.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
50
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
2
Sponsor
Name of organization / entity
Cognitive Science and Technologies Council
Full name of responsible person
Seyed Kamal Kharrazi
Street address
No 35, Cognitive Science and Technologies Council Building, Alvand St, Argentina Sq, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1967875319
Phone
+98 21 8819 4956
Fax
+98 21 8819 4954
Email
info@cogc.ir
Web page address
https://cogc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?