Investigating the Brain's Physiological Responses in Depression and Autism, Using Transcranial Magnetic Stimulation and Electroencephalography

NCT06821646 | Enrolling By Invitation DMC

• 1 other identifier: 202209019DINB
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to investigate the brain physiological responses in depression and autism. The main questions aim to answer are:

1. 1.Comparing the ratios of cortical excitation and inhibition among four groups: autism group, autism with depression group, depression group, and normal control group using Transcranial magnetic stimulation and electroencephalography (TMS-EEG). This study explores the relationship between the ratios of cortical excitation and inhibition and the severity of clinical symptoms.
2. 2.Comparing the brain inflammation among four groups: autism group, autism with depression group, depression group, and normal control group using Positron emission tomography (PET). This study investigates the relationship between brain inflammation and the severity of clinical symptoms.
3. 3.The mutual influence between the severity of brain inflammation and Excitatory/inhibitory imbalance (E/I imbalance).

Conditions

Autism; Major Depressive Disorder (MDD)

Keywords

Autism; Major Depressive Disorder; FEPPA PET; TMS-EEG

Outcome Measures

Primary Outcomes (2)

• Standardized Uptake Value (SUV) of Translocator Protein activity imaged by Positron Emission Tomography (PET)

  1 hour

• Standardized Uptake Value (SUV) of Translocator Protein activity recorded by transcranial magnetic stimulation and electroencephalography(TMS-EEG)

  2 hours

Secondary Outcomes (1)

• the total composite scores of multiple scales

  2 hours

Study Arms (4)

Autism

Diagnostic Test: Positron Emission Tomography (PET); Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG)

Major Depression Disorder

Diagnostic Test: Positron Emission Tomography (PET); Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG)

Autism, Major Depression Disorder

Diagnostic Test: Positron Emission Tomography (PET); Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG)

Typically Developing Control

Diagnostic Test: Positron Emission Tomography (PET); Diagnostic Test: transcranial magnetic stimulation and electroencephalography(TMS-EEG)

Interventions

transcranial magnetic stimulation and electroencephalography(TMS-EEG) DIAGNOSTIC_TEST

single pulse and paired pulse

Autism; Autism, Major Depression Disorder; Major Depression Disorder; Typically Developing Control

Positron Emission Tomography (PET) DIAGNOSTIC_TEST

18F-N-((2-(2-(fluoro-18f)ethoxy)phenyl)methyl)-N-(4-phenoxy-3-pyridinyl) acetamide

Autism; Autism, Major Depression Disorder; Major Depression Disorder; Typically Developing Control

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

National Taiwan University Hospital

You may qualify if:

• Autism group : Adults aged 20-50 diagnosed with autism spectrum disorder。Intelligence Quotient(IQ) \> 70, with autonomous abilities.
• Autism group with comorbid depression : Adults aged 20-50 diagnosed with autism spectrum disorder. Diagnosed with depression. IQ \> 70. Not on antidepressants for at least one week, with autonomous abilities.
• Major depression disorder group : Adults aged 20-50. Diagnosed with major depressive disorder according to Diagnostic and Statistical Manual of Mental Disorders-IV-TR(DSM-IV-TR). IQ \> 70. Not on antidepressants for at least one week, with autonomous abilities.
• Typically developing control group : Adults aged 20-50. Never diagnosed with autism spectrum disorder. Never diagnosed with depression. IQ \> 70, with autonomous abilities.

You may not qualify if:

• Previously diagnosed with bipolar disorder, schizophrenia, attention deficit hyperactivity disorder (ADHD), or substance use disorder according to DSM-IV.
• Previously suffered from major medical or neurological diseases.
• Brain structural abnormalities (e.g., brain tumor or arteriovenous malformations) or neurological diseases (e.g., meningitis, encephalitis, stroke, or epilepsy).
• Previously undergone or soon to undergo brain surgery, or have metal implants in the head or neck area, such as neuro-stimulators or cochlear implants.
• Have a cardiac pacemaker.
• Pregnant participants.
• Participants with strong suicidal intentions.
• Other conditions that render the patient unable to cooperate, such as unsuitability after screening, unstable physical illness, or refusal to sign the informed consent.
• Claustrophobia, unable to undergo positron emission tomography(PET) and functional magnetic resonance imaging (fMRI) scans.
• Taking medications that may affect Excitatory/inhibitory balance (E/I balance).

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: collaborator
• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Autistic Disorder; Depressive Disorder, Major

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2025
• First Posted: February 12, 2025
• Study Start: May 28, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 12, 2026

Record last verified: 2025-12

Locations

TW (1)