Dual-target iTBS for Youth With ADHD

NCT07084649 | Recruiting Phase 1 DMC

• 1 other identifier: IRB, SMHC, 2025-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (2)

• Effectiveness as measured by SNAP-IV Parent Rating Scale (assessing inattention/hyperactivity-impulsivity)

  SNAP-IV is used to assess the core symptoms of ADHD (inattention, hyperactivity/impulsivity) and symptoms of oppositional defiant disorder; the total score or subscale mean scores indicate symptom severity, with higher scores reflecting more pronounced symptoms.

  ADHD symptoms will be measured before the TMS treatment, immediately after completion of the TMS treatment.

• Clinical Global Impression-Severity Scale (CGI)

  CGI is used to evaluate disease severity and treatment response.

  GCI will be measured before the TMS treatment, immediately after completion of the TMS treatment.

Secondary Outcomes (6)

• Safety as measured by number of participants with Adverse Events

  Each afternoon after treatment during the 5 days of treatment

• Acceptability as assessed by treatment-related dropout rates

  Each afternoon after treatment during the 5 days of treatment

• BRIEF（Behavior Rating Inventory of Executive Function）

  Will be measured before the TMS treatment, immediately after completion of the TMS treatment.

• PedsQL（Pediatric Quality of Life Inventory）

  Will be measured before the TMS treatment, immediately after completion of the TMS treatment.

• A cognitive task battery

  Will be measured before the TMS treatment, immediately after completion of the TMS treatment.

Study Arms (3)

Phase 1: Open-label dual-target aiTBS

EXPERIMENTAL

Phase 1: Open label, single arm study to determine the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD.

Device: TMS

Phase 2: RCT design active aiTBS

ACTIVE COMPARATOR

Phase 1: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD.

Device: TMS

Phase 2: RCT design sham aiTBS

SHAM COMPARATOR

Phase 2: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD.

Device: TMS

Interventions

TMS DEVICE

accelerated intermittent theta burst stimulation

Phase 1: Open-label dual-target aiTBS; Phase 2: RCT design active aiTBS; Phase 2: RCT design sham aiTBS

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, None Selected, 200030, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Huiru Cui, Ph.D

CONTACT

+862134773243; cuihuiru@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Phase 1：open label；Phase 2: double-blind masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 1 is an open-label, single-arm study to explore the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD. • Phase 2 is a randomized, double-masked, controlled trial that will rigorously validate the results of Phase 1. The decision to proceed depends on Phase 1 results: * If Phase 1 demonstrates positive outcomes in clinical symptoms, cognitive functioning, safety, and acceptability, Phase 2 will be implemented. * If Phase 1 fails to show positive results, Phase 2 will be discontinued.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 24, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)