Dual-target iTBS for Youth With ADHD

Sponsor
Shanghai Mental Health Center
Study ID
NCT07084649
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS — DEVICE
    accelerated intermittent theta burst stimulation

Study Details

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.

Key Dates

First listed
Jul 24, 2025
Start date
Jan 1, 2025
Status verified
Jul 2025
Primary completion
Sep 1, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Effectiveness as measured by SNAP-IV Parent Rating Scale (assessing inattention/hyperactivity-impulsivity) [ Time Frame: ADHD symptoms will be measured before the TMS treatment, immediately after completion of the TMS treatment. ]

Central Contacts

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