Clinical Study on a Novel Strategy of Individualized Non-Invasive Neuromodulation for the Treatment of Tic Disorders in Children

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Tic Disorders

Treatments: Device: Transcranial Magnetic Stimulation; Behavioral: general behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07351955

LY202504140

Details and patient eligibility

About

This study aims to establish a novel personalized closed-loop NiBS/TMS therapeutic strategy and clinical protocol for children with Tic Disorders (TDs) through a series of scientific investigations. Additionally, it seeks to elucidate the underlying neural circuit mechanisms, enhance the therapeutic efficacy of TMS in pediatric TDs, and achieve precision neuromodulation for children with TDs.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 months to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1: Children and adolescents aged 5 to 18 years

  2: Meets DSM-5 diagnostic criteria for Tic Disorders (TDs) with normal EEG findings

  3: No prior treatment received for TDs

  4: Full-scale intelligence quotient (FIQ) ≥70 on the Wechsler Intelligence Scale for Children-Revised (WISC-R)

Exclusion criteria

• 1: WISC-R Full-Scale Intelligence Quotient (FIQ) <70

  2: Presence of metal implants in the body ，Non-right-handedness

  3: Head movement (HM) >2mm during fMRI scanning, including both translational movement (TM) and rotational movement (RM)

  4: Any other neurological or psychiatric conditions, including but not limited to autism spectrum disorder (ASD), epilepsy, obsessive-compulsive disorder (OCD), etc

  5: Previous head trauma ，Neurological diseases ，Major systemic illnesses

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

The child will use a transcranial magnetic stimulator model ZL-N-010 to stimulate preselected targets located in the prefrontal lobe, bilateral temporal lobes, and parietal lobe. The child may rest as needed during the treatment process. Each TMS session lasts approximately 30 minutes. A total of 10 sessions will be administered. They will also use general behavioral therapy.

Treatment:

Behavioral: general behavioral therapy

Device: Transcranial Magnetic Stimulation

Sham-Controlled Observation Group

Placebo Comparator group

Description:

The child will receive sham stimulation and general behavioral therapy.

Treatment:

Behavioral: general behavioral therapy