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Evaluation of Theta Burst Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder

NCT06040775 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-09-26

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate Theta Burst Transcranial Magnetic Stimulation as an adjunct to standard therapy in improving core function deficits in children 5-15 year age with Autism Spectrum disorder. The main question it aims to answer is whether Theta burst Transcranial Magnetic Stimulation would improve core function deficit in children age 5 - 15 years with Autism Spectrum Disorder as an adjunct to standard therapy. Participants will receive patterned transcranial magnetic stimulation- theta burst stimulation for consecutive 7 days with standard therapy and the comparison group would receive standard therapy alone. Outcome in the form of change in obsessive, repetitive behavior would be measured at 1 month from end of therapy

Conditions

Interventions

DEVICE

Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil

Site of stimulation will be predetermined at Dorsolateral prefrontal cortex of non-dominant side using the BeamF3 method.1 burst will be - 3 pulses at 50 Hz, burst will be set at 5Hz i.e. interburst interval 200ms . At100% of resting motor threshold of dominant side - 5 trains (each 40sec on and 20 sec off) will be given at each session with a pause of 1 minute in between 2 trains Standard therapy with Applied Behavior Analysis and sensory integration would continue

DEVICE

Sham magnetic stimulation using sham MCF-B65 coil

Similar set parameters using a sham coil which simulates sound and tactile effect of real coil but no electromagnetic induction is produced. Standard therapy with Applied Behavior Analysis and sensory integration would continue

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Sheffali Gulati · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-15
Primary Completion
2024-09-15
Completion
2024-09-30

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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 NCT06040775 on ClinicalTrials.gov