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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 18
Healthy Volunteers: f
View:

• 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:

⁃ 1\) 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.

Locations
Other Locations
China
Shanghai Mental Health Center
RECRUITING
Shanghai
Contact Information
Primary
Huiru Cui, Ph.D
cuihuiru@163.com
+862134773243
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 15
Treatments
Experimental: Phase 1: Open-label dual-target aiTBS
Phase 1: Open label, single arm study to determine the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD.
Active_comparator: Phase 2: RCT design active aiTBS
Phase 1: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD.
Sham_comparator: Phase 2: RCT design sham aiTBS
Phase 2: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD.
Sponsors
Leads: Shanghai Mental Health Center

This content was sourced from clinicaltrials.gov