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

NCT06305988 | Completed

• 1 other identifier: LYG2023021
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ASD

Outcome Measures

Primary Outcomes (1)

• Autism assessment assessment index

  3\. 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).

  Baseline, the day after intervention, three weeks after intervention

Secondary Outcomes (6)

• EEG physiological detection index

  Baseline, the day after intervention, three weeks after intervention

• Social Communication Changes index

  Baseline, the day after intervention, three weeks after intervention

• Stereotyped behavior index

  Baseline, the day after intervention, three weeks after intervention

• Sensory index

  Baseline, the day after intervention, three weeks after intervention

• Abnormal behavior indicator

  Baseline, the day after intervention, three weeks after intervention

Other Outcomes (2)

• Plasma Metabolite Levels Assessment

  At baseline, the first day of intervention

• Safety evaluation SAFTEE indicator

  Baseline, the day after intervention, three weeks after intervention

Study Arms (2)

intervention group（Transcranial direct current stimulation）

EXPERIMENTAL

tDCS group participants will receive tDCS intervention stimulation for 1 week (1.5mA, 20min/ time, twice a day)

Device: Transcranial direct current stimulation

control group（Sham Transcranial direct current stimulation）

PLACEBO COMPARATOR

Placebo comparator group subjects will receive similar sites and the same frequency of spurials (0mA, 20min/ time, twice daily) for 1 week

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

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.

control group（Sham Transcranial direct current stimulation）; intervention group（Transcranial direct current stimulation）

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• b) Imaging examination showed significant brain structural abnormalities;
• c) Having serious neurological diseases, a clear family history, or potential risks;
• d) Metal or pacemaker implantation in the body, holes or cracks in the skull;
• e) Taking benzodiazepines or anticonvulsants;
• f) The existence of clear or suspicious genetic diseases;
• g) Conforming to the diagnosis of other serious mental illnesses, such as schizophrenia and bipolar disorder.

Sponsors & Collaborators

• Jian-Jun Ou: lead

Study Sites (1)

Department of Psychiatry, Xiangya Second Hospital, Central South University

Changsha, Hunan, 410000, China

Location

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jianjun Ou, doctor

  Central South University

  STUDY CHAIR

• Yanting Hou, doctor

  Central South University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: March 12, 2024
• Study Start: August 1, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)