RecruitingPhase 1Phase 2NCT07084649

Dual-target iTBS for Youth With ADHD

The Efficacy of Dual-target iTBS in Youth With Attention-Deficit/Hyperactivity Disorder (ADHD)

Sponsor

Shanghai Mental Health Center

Enrollment

15 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

ADHD

Summary

This study will employ accelerated intermittent theta burst stimulation (aiTBS) targeting two transcranial magnetic stimulation (TMS) sites: the right inferior frontal gyrus and left inferior parietal lobule.

Eligibility

Min Age: 10 YearsMax Age: 18 Years

Inclusion Criteria7

ADHD Diagnosis: Meets the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
Inadequate Response to Medication: After a full course of pharmacological treatment, the SNAP-IV Parent Rating Scale (first 18 items, assessing inattention/hyperactivity-impulsivity) score >1, and the Clinical Global Impression-Severity Scale (CGI-S) score >2;
Age and Gender: 10-18 years old; males or females;
Intellectual Functioning: Full-scale intelligence quotient (IQ) >70 on the China-Wechsler Intelligence Scale for Children (C-WISC) (excluding participants with intellectual disability);
Symptom Severity: A score of ≥1.6 on either the Inattention or Hyperactivity/Impulsivity subscale of the SNAP-IV Parent Rating Scale;
Medication Requirements:
\) Medication-naïve or currently off medication; 2) If currently on medication, must be on a stable medication regimen for at least 4 weeks prior to the baseline visit and throughout the study duration; 3) Prohibited medications: Psychostimulants; 7. Right-handed.

Exclusion Criteria9

Contraindications for TMS therapy include epilepsy, cardiac pacemakers, cochlear implants, and metal implants.
Contraindications for MRI include metal implants in the body, claustrophobia, and tattoos.
Significant medical history: history of epilepsy, organic brain disorders, traumatic brain injury (TBI), or severe physical illnesses.
Behavioral risks: history of violent or suicidal behavior.
Comorbid neurodevelopmental disorders, such as autism spectrum disorder (ASD), tic disorders, etc.
Comorbid psychiatric disorders: any other primary psychiatric disorders, except conduct disorder/oppositional defiant disorder, mild anxiety, or depression.
Substance abuse.
Currently receiving any non-medical treatments, such as cognitive behavioral therapy (CBT), neurofeedback, etc.
Female participants must not be pregnant or breastfeeding.

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Interventions

DEVICETMS

accelerated intermittent theta burst stimulation

Locations(1)

Shanghai Mental Health Center

Shanghai, None Selected, China

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NCT07084649

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