NCT06389864

rTMS in Children and Adolescents With ADHD:

High Frequency rTMS in Children and Adolescents With ADHD: a Randomized, Double Blind Clinical Trial.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Sixty children with ADHD of both sexes and ages ranging between 8 and 16 years old were included in the study. Randomization of patients: Our patients in each subgroup were randomly allocated to intervention arms (real versus sham) by using serially numbered opaque closed envelopes. Each patient was placed in the appropriate group after opening the corresponding sealed envelope. The official sheet of the assiut university of Psychiatry was used for the assessment and interview. This includes demographic data, personal and family history, medical history, and mental state examination. All subjects were then assessed using the Full psychiatric interview (Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) to diagnose ADHD and to exclude other diagnoses according to DSM5 classification, which took place in the first interview with the participants before the start of the study. An informed written consent was offered for the parents of the patients participating in the study. All participants were on drugs (stimulants and non-stimulants), and all other medications were stopped 2 weeks before the beginning of the study. Atomoxetine was (from 0.5 to 1.2 mg/ kg/day )(24-25-26) . thirty participants were allocated to the rTMS group who received 15 sessions of rTMS over the right DLPC, in conjunction with Atomoxetine 1.2 mg/kg/day. The other 30 participants were allocated to the Sham control group who received 15 sessions of sham rTMS and atomoxetine 1.2 mg/kg/day. All participants underwent assessments of the severity of ADHD symptoms done at 3 points, before the beginning of treatment (pre), after receiving 15 sessions of rTMS/Sham rTMS (post), and on follow-up 1 month after treatment (FU) (27), using Arabic version Conners' Parent Rating Scale - Revised Long form ,Clinical Global Impression and the resting motor threshold (RMT). The scores pre, post, and follow-up were compared to evaluate the improvement of clinical symptoms, and the therapeutic effects among the 2 groups were also compared. rTMS was delivered through a figure of 8 coil (the outer diameter of each wing is 9 cm, the maximum field strength=1.9 tesla) attached to a Magstim (UK) super rapid magnetic stimulator, (28) which administered at 10 Hz directed to the right dorsolateral prefrontal cortex, located at the F4 location from the EEG 10-20 system. 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) in the active TMS condition. For the sham rTMS, the coil was tilted over the right dorsolateral pre-frontal cortex without touching the scalp. Participants who received less than 75% of the number of sessions (12 sessions) were considered dropouts.

Conditions

• ADHD

Interventions

Type	Name	Description
DEVICE	rTMS (repetitive transcranial magnetic stimulation)	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.

Timeline

• Start date: 2024-10-10
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2024-04-29
• Last updated: 2024-08-06