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ASDNCT06305988

Neuroregulatory Effect and Mechanism of tDCS on Medial Prefrontal Cortex in ASD

A study testing Transcranial direct current stimulation in people with ASD, run by Jian-Jun Ou at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In this proposed study, a transcranial direct current stimulator is used to intervene in the medial prefrontal cortex of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed. Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
ASD
What is being tested?
Transcranial direct current stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteChina
Study dates
1 Aug 2023to 31 May 2024
Phase
Interventional
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 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 4-18 years old;
  • Clinically diagnosed by a psychiatrist with autism spectrum disorder;
  • Confirmed by researchers (pediatric psychiatrists) that they meet the diagnostic criteria for autism spectrum disorders in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) of the United States;
  • Evaluated by researchers (pediatric psychiatrists) using the Autism Diagnostic Interview Revised (ADI-R) and Autism Diagnostic Observation Schedule (ADOS), it is consistent with the diagnosis of autism spectrum disorders;
  • Capable of cooperating with magnetic resonance spectroscopy and transcranial direct current stimulation.

Who cannot join

  • a) Existence of serious physical diseases and conditions, such as significant intracranial lesions, thyroid diseases, epilepsy, congenital heart disease, severe hematological diseases, systemic lupus erythematosus, visual and auditory impairments, etc;
  • Imaging examination showed significant brain structural abnormalities;
  • Having serious neurological diseases, a clear family history, or potential risks;
  • Metal or pacemaker implantation in the body, holes or cracks in the skull;
  • Taking benzodiazepines or anticonvulsants;
  • The existence of clear or suspicious genetic diseases;
  • Conforming to the diagnosis of other serious mental illnesses, such as schizophrenia and bipolar disorder.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Psychiatry, Xiangya Second Hospital, Central South University

    Changsha, Hunan, 410000

Other trials in China

About this study

Official title: Neuroregulatory Effect and Mechanism of Transcranial Direct Current Stimulation on Medial Prefrontal Cortex in Autism Spectrum Disorder

In this proposed study, a transcranial direct current stimulator is used to intervene in the medial prefrontal cortex of children with autism, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of Autism Spectrum Disorders' intervention is discussed.

Read the detailed description

This is a randomized controlled double-blind trial. Using a transcranial direct current stimulator to stimulate the Autism Spectrum Disorders of children with autism, place an anode patch on Fz and a cathode patch on right cheek to observe whether it can improve social and cognitive function in autism. Parameter settings: The current size is 1.5mA. Treat twice a day for 20 minutes, for a total of 7 days.

Conditions
ASD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial direct current stimulationDevice

    The anode patch is placed in Fz, and the cathode patch is placed on right cheek, powered by direct current with a current of 1.5mA. Subjects in the placebo comparator group will receive sham tDCS for 1 week, which mimics the tDCS intervention in terms of electrode placement and session frequency. However, the device will deliver a 0mA current, ensuring no actual stimulation occurs. The anode patch is placed at Fz, and the cathode patch is positioned on the right cheek, to maintain the blinding of the intervention.

Study groups in NCT06305988
Study groupRoleWhat they receive
intervention group（Transcranial direct current stimulation）ExperimentaltDCS group participants will receive tDCS intervention stimulation for 1 week (1.5mA, 20min/ time, twice a day)
Receives: Device: Transcranial direct current stimulation
control group（Sham Transcranial direct current stimulation）Placebo comparatorPlacebo comparator group subjects will receive similar sites and the same frequency of spurials (0mA, 20min/ time, twice daily) for 1 week
Receives: Device: Transcranial direct current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Autism assessment assessment index

    1. Autism was assessed using the Oregon State University Autism Rating Scale, DSM-5 (OARS-5), which includes the signs and symptoms of autism spectrum disorders described in the DSM-5. The scores include :1; Total number of symptoms. Every symptom that occurs (i.e., 1, 2, or 3 points) is recorded in the symptom count. 2. Weighted average severity. The clinician scored each item on a scale of 0, 1, 2 or 3 based on the parent's description of the particular problem. 3. Damage index. In Section C of OARS-5, after discussion with the child/adolescent's caregiver, the clinician will rate the level of support on a scale of 0(no support) to 3(maximum support).

    Measured: Baseline, the day after intervention, three weeks after intervention

Secondary outcomes (6)

  1. EEG physiological detection index

    detect resting state and task state EEG, analyze and calculate the functional E/I ratio of EEG power spectrum

    Measured: Baseline, the day after intervention, three weeks after intervention

  2. Social Communication Changes index

    Assessed by the Social Response Scale (SRS-II). The change in social communication scores from baseline to the end of the study period will be the primary outcome of interest, the critical value is 59.5, and the total score is the sum of all entries, with the lowest score of 0 and the highest score of 3 for each entry.

    Measured: Baseline, the day after intervention, three weeks after intervention

  3. Stereotyped behavior index

    The Repetitive Stereotyping Behavior Scale-Revised (RBS-R) is a tool used to assess repetitive and stereotyping behaviors in autism spectrum disorders (ASD) and other related disorders. The scale consists of 5 subscales, namely Ⅰ stereotypical behavior scale, Ⅱ self-injury behavior scale, Ⅲ impulsive behavior scale, Ⅳ ritualistic behavior scale, Ⅴ fixed behavior scale, and the score is 0= these behaviors have never happened -- 3= these behaviors have happened. And it's serious; The number of positive items is items other than those with a zero score.

    Measured: Baseline, the day after intervention, three weeks after intervention

  4. Sensory index

    The Short Sensory Profile (SSP) was used to assess sensory processing abnormalities in children. Each statement has a rating range, which is a 5-point scale from "always" to "never." Raters need to rate the child based on how often they respond to specific sensory inputs. The total score of the SSP is the sum of the scores of all entries. The lowest score generally reflects a higher level of sensory processing difficulty, while the highest score indicates less difficulty.

    Measured: Baseline, the day after intervention, three weeks after intervention

  5. Abnormal behavior indicator

    Individuals are assessed for behavioral abnormalities using the Aberrant Behavior Checklist-Second Edition (ABC-II), a scoring system designed according to the frequency and severity of behavioral problems. For each entry, raters are asked to rate it according to the following criteria: 0: no problem at all. Score 1: The behavior is problematic, but the degree is not serious. Score 2: The problem is moderately serious. 3 marks: The problem is serious. The total score for ABC-II is the sum of scores for all entries, with the lowest score (i.e., all entries are rated 0) indicating that no behavioral problems were observed, while the highest score (i.e., all entries are rated 3) indicating widespread and serious behavioral problems.

    Measured: Baseline, the day after intervention, three weeks after intervention

  6. Sleep index

    Childhood Sleep Disorders Scale (SDSC) was used to assess children's sleep problems and habits. Ratings are usually based on frequency and duration, such as "always," "often," "sometimes," "occasionally," or "never happens." Each entry is typically scored on a scale of 0 to 5, with 0 being no problem and the highest being the most serious. The total score of the CSHQ is the sum of the scores of all entries.

    Measured: Baseline, the day after intervention,three weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start1 Aug 2023
  3. Primary completion31 May 2024
  4. Study completion31 May 2024

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06305988
Sponsor's protocol ID
LYG2023021
Status last verified
Jun 2024
First submitted
26 Jan 2024
Last updated
27 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation in people with ASD, run by Jian-Jun Ou at 1 site in China.

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 5 inclusion and 7 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 27 Jun 2024. 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 China. 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.

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?

Autism assessment assessment index (time frame: Baseline, the day after intervention, three weeks after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06305988.

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 27 Jun 2024.

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