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A study to Assess the Effect of repetitive transcranial magnetic stimulation as an Adjunct to Applied behavior analysis in Children and Adolescents with Autism Spectrum Disorder

A Double-Blind Randomised Sham-Controlled Trial for Assessing the Effect of repetitive transcranial magnetic stimulation as an Adjunctive Treatment in Children and Adolescents with Autism Spectrum Disorder - None

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067296
Enrollment
20
Registered
2024-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F840- Autistic disorder

Interventions

Intervention1: repetitive transcranial magnetic stimulation-iTBS: iTBS - bursts of 3 pulses at frequency of 50 Hz every 200 ms 2 s of TBS trains (30 pulses) are repeated every 10 s for 190 s, with a t

Sponsors

AIIMS, New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Social Quotient more than 70 Meeting DSM 5 criteria for ASD Right handed Parents willing to give written informed consent for participation in the study Children willing to give assent Patients stable on psychotropic medication for a period of at least 2 months

Exclusion criteria

Exclusion criteria: Social Quotient less than 70 or mild moderate or severe intellectual disability, or any other comorbid psychiatric syndrome diagnosis or substance use disorder History of seizure History of receiving any treatment with brain stimulation Parents not willing for participation in study Presence of unstable medical illness Reported History suggestive of space occupying brain lesion or cerebrovascular accident Having implanted device or metal in brain head or cardiac pacemaker or ferromagnetic dental braces

Design outcomes

Primary

MeasureTime frame
To assess the improvement of social relationships and reciprocity, emotional responsiveness, speech and language communication, behavior patterns, and sensory aspects of ASD after rTMS in children and adolescents with simultaneous Applied Behavior Analysis TherapyTimepoint: 1 week before rTMS (pre rTMS) Post rTMS: 3 weeks, at 4 weeks and 12 weeks follow up.

Secondary

MeasureTime frame
To assess the persistence in improvement post rTMS at 1month and 3month intervals and assess safety with adverse event reporting.Timepoint: At 4 weeks and 12 weeks

Countries

India

Contacts

Public ContactShaheen Sithara S

All India Institute of Medical Sciences New Delhi

nandkm2001@gmail.com9899943146

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026