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

ConditionTic Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-18
SponsorShanghai Children's Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1: Children and adolescents aged 5 to 18 years

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcranial Magnetic Stimulation

    Device

    Transcranial magnetic stimulation (TMS) will be administered to the child using a ZL-N-010 model device, targeting predefined sites in the prefrontal, bilateral temporal, and parietal lobes.

  • general behavioral therapy

    Behavioral

    Behavioral interventions include avoiding screen time, parental avoidance of scolding or corporal punishment, and steering clear of activities or emotional stimuli that may exacerbate symptoms.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 2 interventions
Group B: Sham-Controlled Observation GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Tic Severity

The severity of the child's clinical tic symptoms assessed via the Yale Global Tic Severity Scale.

Time frame
10 weeks
2

Changes in brain region activation intensity and resting-state connectivity before and after treatment.

Based on fMRI imaging, changes in brain region activation intensity (BOLD signals) and resting-state functional connectivity (FC) before and after treatment were compared.

Time frame
10 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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