Autism Spectrum DisorderPhase 1NCT05491720
Electrical Brain Stimulation and Pharmacological Treatments in Autism Spectrum Disorder
A Phase 1 study testing RisperiDONE 1 MG/ML and transcranial direct current stimulation in people with Autism Spectrum Disorder, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
Trial summary
This project aims to comparing the effectiveness of transcranial direct current stimulation with common pharmacological treatments on behavioral problems and cognitive deficits of children with autism spectrum disorder Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- RisperiDONE 1 MG/ML and transcranial direct current stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteIran
- Study dates
- 15 Aug 2020to 3 Aug 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of autism spectrum disorder by a psychiatrist and behavioral checklist
- being 6-16 years old
- providing written informed consent signed by parents
Who cannot join
- comorbidity with other neurodevelopmental disorders
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparable Efficacy of Transcranial Direct Current Stimulation and Pharmacological Treatments in Children With Autism Spectrum Disorder
This project aims to comparing the effectiveness of transcranial direct current stimulation with common pharmacological treatments on behavioral problems and cognitive deficits of children with autism spectrum disorder
Read the detailed description
45 children with autism spectrum disorder are recruited in Fatemi Hospital at Ardabil University of Medical Sciences. The patients will be randomized into 3 Intervention groups of 15 with tDCS stimulation, risperidone, and placebo medication as the interventions. The study will be a randomized double-blind controlled design. The experimenter and the patient are blinded and are not aware of the study. Intervention group 1: 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 F3 and cathodal electrode will be placed over the Fp2. They will also receive a placebo tablet (Galenus pharmaceutical company) in each stimulation session. Intervention group 2: Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days. Intervention group 3: Participants in this group undergo 10 daily sessions of sham tDCS concurrent with a placebo tablet (Galenus pharmaceutical company) for 10 consecutive days.
- Conditions
- Autism Spectrum Disorder
- Being tested
- RisperiDONE 1 MG/ML, transcranial direct current stimulation, Placebo, sham transcranial direct current stimulation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperiDONE 1 MG/MLDrug
Patients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days
transcranial direct current stimulationDevice
Also called tDCS
Patients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days
PlaceboDrug
Patients will receive placebo tablet (Galenus pharmaceutical company)
sham transcranial direct current stimulationDevice
Patients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Experimental | 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. Receives: Device: transcranial direct current stimulation; Drug: Placebo |
| Medication group | Experimental | Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days Receives: Drug: RisperiDONE 1 MG/ML; Device: sham transcranial direct current stimulation |
| Control group | Placebo comparator | Participants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days. Receives: Drug: Placebo; Device: sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gilliam Autism Rating Scale (GADS)
Score in the Gilliam Autism Rating Scale (GADS)
Autism index scores:
69 or less = unlikely 70-84 = possible 85 or higher = very likely
Measured: up to 3 months after the intervention
verbal fluency task
Performance in the verbal fluency task as an executive and language function task
Measured: up to 3 months after the intervention
Theory of mind
Score in the Theory of Mind Test (ToMT) Score range of subscales 1 to 3, is 0-20, 0-13, and 0-5, respectively and the total score range is 0-38.
Measured: up to 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start15 Aug 2020
- Primary completion15 Mar 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)
- Sponsor type
- University, hospital or other
- Collaborators
- Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors, University of Tehran
- Responsible party
- Principal investigator, Mohammad Ali Salehinejad, The National Brain Mapping Laboratory (NBML)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491720
- Sponsor's protocol ID
- IR.ARUMS.REC.1395.20
- Status last verified
- Nov 2023
- First submitted
- 4 Aug 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparable Efficacy of Transcranial Direct Current Stimulation and Pharmacological Treatments in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT05491720
- Acronym / sponsor ID
- IR.ARUMS.REC.1395.20
- Conditions
- Autism Spectrum Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)University, hospital or other
- Collaborators
- Ardabil University of Medical Sciences, Leibniz Research Centre for Working Environment and Human Factors, University of Tehran
- Study start
- 15 Aug 2020 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to comparing the effectiveness of transcranial direct current stimulation with common pharmacological treatments on behavioral problems and cognitive deficits of children with autism spectrum disorder
Detailed description
45 children with autism spectrum disorder are recruited in Fatemi Hospital at Ardabil University of Medical Sciences. The patients will be randomized into 3 Intervention groups of 15 with tDCS stimulation, risperidone, and placebo medication as the interventions. The study will be a randomized double-blind controlled design. The experimenter and the patient are blinded and are not aware of the study. Intervention group 1: 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 F3 and cathodal electrode will be placed over the Fp2. They will also receive a placebo tablet (Galenus pharmaceutical company) in each stimulation session. Intervention group 2: Participants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days. Intervention group 3: Participants in this group undergo 10 daily sessions of sham tDCS concurrent with a placebo tablet (Galenus pharmaceutical company) for 10 consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Experimental | Device: transcranial direct current stimulation, Drug: PlaceboTDCS 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. |
| Medication group | Experimental | Drug: RisperiDONE 1 MG/ML, Device: sham transcranial direct current stimulationParticipants in this group will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days |
| Control group | Placebo comparator | Drug: Placebo, Device: sham transcranial direct current stimulationParticipants in this group undergo 10 daily sessions of sham tDCS concurrent with placebo tablets ( Galenus pharmaceutical company) for 10 consecutive days. |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosis of autism spectrum disorder by a psychiatrist and behavioral checklist
- being 6-16 years old
- providing written informed consent signed by parents
Key exclusion criteria (6 listed)
- comorbidity with other neurodevelopmental disorders
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperiDONE 1 MG/MLPatients will receive two daily Risperidone 1 mg tablets (Sobhan Pharmaceutical Company) for 10 consecutive days | Drug | Medication group |
| transcranial direct current stimulationAlso: tDCSPatients will receive 10 sessions of 20 minutes of 1.5 mA electrical stimulation on consecutive days | Device | tDCS group |
| PlaceboPatients will receive placebo tablet (Galenus pharmaceutical company) | Drug | Control group, tDCS group |
| sham transcranial direct current stimulationPatients will receive 10 sessions of 20 minutes of sham electrical stimulation on consecutive days | Device | Control group, Medication group |
Primary outcome
Gilliam Autism Rating Scale (GADS)
Time frame: up to 3 months after the intervention
Score in the Gilliam Autism Rating Scale (GADS) Autism index scores: 69 or less = unlikely 70-84 = possible 85 or higher = very likely
verbal fluency task
Time frame: up to 3 months after the intervention
Performance in the verbal fluency task as an executive and language function task
Theory of mind
Time frame: up to 3 months after the intervention
Score in the Theory of Mind Test (ToMT) Score range of subscales 1 to 3, is 0-20, 0-13, and 0-5, respectively and the total score range is 0-38.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RisperiDONE 1 MG/ML and transcranial direct current stimulation in people with Autism Spectrum Disorder, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gilliam Autism Rating Scale (GADS) (time frame: up to 3 months after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.