Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder
NCT ID: NCT05491720
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
45 participants
INTERVENTIONAL
2020-08-15
2022-08-03
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
tDCS on Working Memory (WM) in Adults With ASD
NCT03255837
Transcranial Direct Current Stimulation in Autistic Spectrum Disorder
NCT05311982
tES Modalities for the Treatment of ADHD
NCT06974136
Transcranial Direct Current Stimulation and Autism
NCT01603225
Cortical Excitability and Role of Non Invasive Brain Stimulation in ADHD and AUTISM
NCT07315217
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
tDCS group
TDCS intervention protocol consists of 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days. Anodal electrode will be placed over the left dorsolateral prefrontal cortex and cathodal electrode will be placed over the right supraorbital area.
transcranial direct current stimulation
Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days
Placebo
Patients will receive placebo tablet (Galenus pharmaceutical company)
Medication group
Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
RisperiDONE 1 MG/ML
Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
sham transcranial direct current stimulation
Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days
Control group
Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days.
Placebo
Patients will receive placebo tablet (Galenus pharmaceutical company)
sham transcranial direct current stimulation
Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
RisperiDONE 1 MG/ML
Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
transcranial direct current stimulation
Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days
Placebo
Patients will receive placebo tablet (Galenus pharmaceutical company)
sham transcranial direct current stimulation
Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* being 6-16 years old
* providing written informed consent signed by parents
Exclusion Criteria
* comorbidity with other neurological disorders
* previous history of neurosurgery
* presence of any ferromagnetic metal in the head
* implanted medical devices in the head or neck region
* history of noncontrolled epilepsy with seizures in the last year
7 Years
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ardabil University of Medical Sciences
OTHER
Leibniz Research Centre for Working Environment and Human Factors
OTHER
University of Tehran
OTHER
The National Brain Mapping Laboratory (NBML)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mohammad Ali Salehinejad
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The National Brain Mapping Laboratory (NBML)
Tehran, , Iran
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IR.ARUMS.REC.1395.20
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.