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Therapeutic Use of rTMS in Pediatric ASD and ADHD Cohorts

NCT06069323 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-10-05

No results posted yet for this study

Summary

In this interventional, pilot clinical trial investigators will stimulate the dorsolateral prefrontal cortex (DLPFC) in patients with Autism and ADHD. The goal of the study is to improve Cognition and Executive Functions associated with this brain region and, consequently, ameliorate the core symptoms of the disorders.

Specifically, the primary purpose is to establish the efficacy, safety, and tolerability of TMS in pediatric patients with ASD and ADHD. Concurrently, the research aims to uncover the impact of TMS on particular biomarkers associated with the development of these disorders and validate the hypothesis suggesting that the BDNF gene polymorphism (Val66Met) could influence an individual's susceptibility to TMS.

Participants will be randomized into the active group and placebo group, to guarantee a real assessment of the impact of neurostimulation on the cognitive, behavioral, and biochemical parameters. Participants will be asked to complete a neuropsychological evaluation and a biological sample collection before and after TMS treatment, and 1-month post-treatment completion.

Conditions

Interventions

DEVICE

repetitive Transcranial Magnetic Stimulation

Pediatric patients with ASD and ADHD will be randomized both in active and sham groups.

Sponsors & Collaborators

  • Ospedali Riuniti di Foggia

    lead OTHER

Principal Investigators

  • Anna N Polito, MD · Neuropsychiatric Unit for Child and Adolescent, at General Hospital "Riuniti" of Foggia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2024-12-31
Completion
2026-06-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06069323 on ClinicalTrials.gov