rTMS in Children and Adolescents With ADHD:

Sponsor
Assiut University
Study ID
NCT06389864
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
6 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • rTMS (repetitive transcranial magnetic stimulation) — DEVICE
    non invasive repetitive transcranial magnetic stimulation rTMS was administered at 10 Hz directed to the right dorsolateral prefrontal cortex. The pulse intensity was set at 80% of the observed motor threshold, 4 s on-train, 26 s off inter-train interval with 2000 pulses per session for 5 sessions per week, for 15 sessions total (i.e., 30,000 pulses total in treatment course) in the active TMS condition. For the sham rTMS, the coil was tilted over the right dorsolateral pre-frontal cortex without touching the scalp.

Study Details

Assess the effect of RTMS on ADHD symptoms and assessment of this effect clinically and objectively.

Key Dates

First listed
Apr 29, 2024
Start date
Oct 10, 2024
Status verified
Aug 2024
Primary completion
Apr 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Real group
    rTMS administered at 10 Hz directed to the right dorsolateral prefrontal cortex. The pulse intensity was set at 80% of the observed motor threshold, 4 s on-train, 26 s off inter-train interval with 2000 pulses per session(29) for 5 sessions per week, for 15 sessions total (i.e., 30,000 pulses total in treatment course).
  • Sham Comparator: Sham control group
    the rTMS coil was tilted over the right dorsolateral pre-frontal cortex without touching the scalp administered at 10 Hz. The pulse intensity was set at 80% of the observed motor threshold, 4 s on-train, 26 s off inter-train interval with 2000 pulses per session for 5 sessions per week. for 15 sessions total.

Primary Outcome Measure

The resting motor threshold (RMT) [ Time Frame: immediately after the end of sessions And follow up 1 month after the end sessions. ]

Central Contacts

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