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

NCT06040775 | Unknown DMC

• 1 other identifier: TBS-ASD
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Change in core function deficit in obsessive and repetitive behavior between intervention and control arm

  Difference in mean change in total Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) and Repetitive Behaviors Scale - Revised (RBS-R) score between intervention and control group CYBOCS- Clinician-report questionnaire, 70 questions, Each on scale of of 0-4, Maximum score -280, minimum score- 0. Higher scores suggest mores severe symptoms RBS-R - Self report/caregiver, 44-item, Each on scale of of 0-4, Maximum score -176, minimum- 0. Higher scores suggest mores severe symptoms

  4 weeks +/- 3 days from end of therapy

Secondary Outcomes (6)

• Change in core function deficit in social behavior and overall autism score between intervention and control arm

  4 weeks +/- 3 days from end of therapy

• Change in core function deficit in social behavior and overall autism score between intervention and control arm

  12 weeks +/- 7 days from end of therapy

• Change in parent reported quality of life as assessed by PedsQL score between intervention and control arm

  4 weeks +/- 3 days from end of therapy and 12 weeks +/- 7 days from end of therapy

• Describe Adverse events noted in intervention and control arm

  4 weeks +/- 3 days from end of therapy

• To describe effect of TBS in clinical tests for executive function using Wisconsin Card Sorting Test (in study population with IQ>70)

  at first visit, at 4 weeks +/- 3 days from end of therapy and at 12 weeks from end of therapy

Study Arms (2)

Theta burst transcranial magnetic stimulation arm

EXPERIMENTAL

Theta burst transcranial magnetic stimulation with Applied Behaviour Analysis

Device: Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil

Sham arm

SHAM COMPARATOR

Sham transcranial magnetic stimulation with Applied Behaviour Analysis

Device: Sham magnetic stimulation using sham MCF-B65 coil

Interventions

Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil DEVICE

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

Also known as: Applied Behavioral Analysis

Theta burst transcranial magnetic stimulation arm

Sham magnetic stimulation using sham MCF-B65 coil DEVICE

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

Also known as: Applied Behavioral Analysis

Sham arm

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• to 15 year age.
• Fulfills DSM-V diagnosis of autism spectrum disorder (ASD)

You may not qualify if:

• Secondary causes of autism
• Global developmental delay, hearing or vision abnormality
• Structural brain abnormalities on imaging
• Genetic or syndromic associations- Down's/Fragile X/Rett's syndrome
• Children on unstable drug regimen- (antipsychotics or anti epileptics) for last 1 months will be excluded
• Neurological or psychiatric disorder other than comorbid disorders of ASD
• Uncontrolled epilepsy as defined by seizure frequency \>1/month for preceding 3 months (including diagnosed patients with CSWS/LKS)
• Severe concurrent illness or disease or unstable medical conditions like pneumonia
• Any contraindications for TMS Implanted electronic device and non-removable metallic objects near coil e.g., pacemaker, cochlear implant Presence of ferromagnetic metal in the head outside the mouth On medication lowering seizure threshold

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sheffali Gulati

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheffali Gulati

CONTACT

9810386847; sheffaligulati@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: September 18, 2023
• Study Start: September 15, 2023
• Primary Completion: September 15, 2024
• Study Completion: September 30, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share