xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06040775</url>
    </required_header>
    <id_info>
      <org_study_id>TBS-ASD</org_study_id>
      <nct_id>NCT06040775</nct_id>
    </id_info>
    <brief_title>Evaluation of Theta Burst Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder</brief_title>
    <official_title>Evaluation of 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 - a Randomized, Double Blind, Sham Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>All India Institute of Medical Sciences, New Delhi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>All India Institute of Medical Sciences, New Delhi</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate Theta Burst Transcranial Magnetic Stimulation&#xD;
        as an adjunct to standard therapy in improving core function deficits in children 5-15 year&#xD;
        age with Autism Spectrum disorder. The main question it aims to answer is whether Theta burst&#xD;
        Transcranial Magnetic Stimulation would improve core function deficit in children age 5 - 15&#xD;
        years with Autism Spectrum Disorder as an adjunct to standard therapy. Participants will&#xD;
        receive patterned transcranial magnetic stimulation- theta burst stimulation for consecutive&#xD;
        7 days with standard therapy and the comparison group would receive standard therapy alone.&#xD;
        Outcome in the form of change in obsessive, repetitive behavior would be measured at 1 month&#xD;
        from end of therapy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Autism spectrum disorder (ASD) is a neurodevelopmental disorder with varying degrees of&#xD;
        severity and symptoms with core deficits in social communication and interaction and&#xD;
        repetitive behavior with restricted interests and activities -American Psychiatric&#xD;
        Association, 2013. Diagnosis requires fulfilment of DSM V criterion for Autism Spectrum&#xD;
        Disorder. ASD is a lifelong disorder with onset in early developmental period and most&#xD;
        patients remain severely impaired in terms of psychosocial functioning throughout their adult&#xD;
        lives.&#xD;
  &#xD;
        Need for exploration of newer treatment modalities - Currently there is no definitive&#xD;
        treatment of Autism and for now the management strategies include - Applied Behavioral&#xD;
        Analysis (ABA), sensory integration, and structured teaching targeting core deficits which&#xD;
        are time taking process and labor intensive from both the caregiver and the provider's&#xD;
        perspective. Pharmacotherapy is effective for targeting associated comorbidities like&#xD;
        irritability, aggression, destructive behavior or hyperactivity and had the added&#xD;
        disadvantage of side effects like sedation. For Complementary and Alternative Medicine&#xD;
        strategies, proof of efficacy has not been unestablished for many. In this context&#xD;
        Transcranial Magnetic Stimulation, TMS may prove to be a good non-invasive neuromodulation&#xD;
        technique and could be an effective tool in the treatment of ASD core manifestations.&#xD;
  &#xD;
        Transcranial Magnetic Stimulation (TMS) is a non-invasive neuromodulation technique. It uses&#xD;
        electromagnetic induction to generate transient, localized electrical fields in the brain&#xD;
        cortex, causes depolarization and firing of local neurons. Acute effects of TMS include&#xD;
        phasic activation of neural circuits and prolonged effects of TMS include alteration in&#xD;
        Neuroplasticity by change in synaptic efficacy, leading to long term potentiation or&#xD;
        long-term depression, this occurs via alteration in neurotropic factor, modulation of&#xD;
        cortical excitability, modulation of functional connectivity. The current study aims to&#xD;
        explore role of patterned TMS known as Theta Burst Stimulation (TBS)- in which pulses are&#xD;
        applied in bursts of three, frequency of 50 Hz and an inter-burst interval of 200 milli&#xD;
        seconds. TBS is a patterned form of repetitive transcranial magnetic stimulation (rTMS)&#xD;
        modelled after endogenous hippocampal discharge patterns and has been shown to be more&#xD;
        efficient than standard rTMS in modulating cortical excitability. The potential advantages of&#xD;
        TBS over rTMS, particularly for children with ASD include shorter overall stimulation&#xD;
        duration (5minutes in TBS). Also, TBS could be better tolerated overall and perhaps even&#xD;
        safer than standard rTMS as sub threshold intensities are given for shorter periods. Effects&#xD;
        of TBS on synaptic plasticity occur much more rapidly than with traditional repetitive TMS&#xD;
        protocols. It is also less noisy due to lower amplitudes used which may reduce hyper sensory&#xD;
        stimulation and may be one of the reasons why TBS could be better tolerated in children with&#xD;
        ASD There seems to be converging in implication of role of dorsolateral prefrontal cortex in&#xD;
        pathophysiology and aberrant neural circuitry of children with ASD. This study aims to study&#xD;
        the effect of TBS as an adjunct to the ongoing standard therapy on core deficits in autism as&#xD;
        measured by CY-BOCS - Children's Yale-Brown Obsessive Compulsive Scale, RBS-R - Repetitive&#xD;
        Behavior Scale- Revised, social behavior change as measured by SRS-2 - Social Responsiveness&#xD;
        Scale- version 2 and overall autistic traits using CARS-2 - Childhood Autism Rating Scale-&#xD;
        version 2 at 1 month and 3 month from end of TBS sessions. It also aims to measure parent&#xD;
        reported quality of life and adverse event rates participants. Change in cognitive function&#xD;
        using Wisconsin card sorting and time to stroop will be used in participants with IQ&gt;70.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 15, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in core function deficit in obsessive and repetitive behavior between intervention and control arm</measure>
      <time_frame>4 weeks +/- 3 days from end of therapy</time_frame>
      <description>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&#xD;
  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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in core function deficit in social behavior and overall autism score between intervention and control arm</measure>
      <time_frame>4 weeks +/- 3 days from end of therapy</time_frame>
      <description>Difference in mean change in total Social Responsiveness Scale, Second Edition (SRS-2) and Childhood Autism Rating Scale, Second Edition (CARS-2) scores between intervention and control group&#xD;
  SRS-2- Parent or teacher questionnaire (65 items on a 4- point Likert scale), Five domain scores (&quot;Treatment Subscales&quot;), Expressed as a raw score or a T-scores. Higher scores more severe social impairment CARS-2 -15 item scale, 1-4 in key areas related to autism diagnosis. For under 12 years of age, scores of 30 or above are indicative of autism and for students 12 years and older, scores of 28 or above are considered to be indicative of autism.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in core function deficit in social behavior and overall autism score between intervention and control arm</measure>
      <time_frame>12 weeks +/- 7 days from end of therapy</time_frame>
      <description>Difference in mean change in total CY-BOCS, RBS-R, SRS-2, CARS-2 scores 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 SRS-2- Parent or teacher questionnaire (65 items on a 4- point Likert scale), Five domain scores (&quot;Treatment Subscales&quot;), Expressed as a raw score or a T-scores. Higher scores more severe social impairment CARS-2 -15 item scale, 1-4 in key areas related to autism diagnosis. For under 12 years of age, scores of 30 or above are indicative of autism and for students 12 years and older, scores of 28 or above are considered to be indicative of autism.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in parent reported quality of life as assessed by PedsQL score between intervention and control arm</measure>
      <time_frame>4 weeks +/- 3 days from end of therapy and 12 weeks +/- 7 days from end of therapy</time_frame>
      <description>Difference in mean change in total Pediatric Quality of Life Inventory (PedsQL) score between intervention and control group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Describe Adverse events noted in intervention and control arm</measure>
      <time_frame>4 weeks +/- 3 days from end of therapy</time_frame>
      <description>Adverse event rate defined as ratio of sessions with adverse events divided by total sessions&#xD;
  Adverse event will be defines as- positive increase in any of the ROS (review of systems) criteria compared to pre therapy (which will be filled at end of each therapy session)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To describe effect of TBS in Clinical test of cognition and executive function (in study population with IQ&gt;70)</measure>
      <time_frame>at first visit, at 4 weeks +/- 3 days from end of therapy and at 12 weeks from end of therapy</time_frame>
      <description>Wisconsin Card Sorting Test- Mean of change in total error score will be calculated for intervention and control arms Stroop test time- Total time to complete 3 paged stroop test (in seconds) will be compared</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">82</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>Theta burst transcranial magnetic stimulation arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Theta burst transcranial magnetic stimulation with Applied Behaviour Analysis</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham arm</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Sham transcranial magnetic stimulation with Applied Behaviour Analysis</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil</intervention_name>
      <description>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 .&#xD;
  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</description>
      <arm_group_label>Theta burst transcranial magnetic stimulation arm</arm_group_label>
      <other_name>Applied Behavioral Analysis</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Sham magnetic stimulation using sham MCF-B65 coil</intervention_name>
      <description>Similar set parameters using a sham coil which simulates sound and tactile effect of real coil but no electromagnetic induction is produced.&#xD;
  Standard therapy with Applied Behavior Analysis and sensory integration would continue</description>
      <arm_group_label>Sham arm</arm_group_label>
      <other_name>Applied Behavioral Analysis</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 5 to 15 year age.&#xD;
  &#xD;
            2. Fulfills DSM-V diagnosis of autism spectrum disorder (ASD)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Secondary causes of autism&#xD;
  &#xD;
                 -  Global developmental delay, hearing or vision abnormality&#xD;
  &#xD;
                 -  Structural brain abnormalities on imaging&#xD;
  &#xD;
                 -  Genetic or syndromic associations- Down's/Fragile X/Rett's syndrome&#xD;
  &#xD;
            2. Children on unstable drug regimen- (antipsychotics or anti epileptics) for last 1&#xD;
               months will be excluded&#xD;
  &#xD;
            3. Neurological or psychiatric disorder other than comorbid disorders of ASD&#xD;
  &#xD;
            4. Uncontrolled epilepsy as defined by seizure frequency &gt;1/month for preceding 3 months&#xD;
               (including diagnosed patients with CSWS/LKS)&#xD;
  &#xD;
            5. Severe concurrent illness or disease or unstable medical conditions like pneumonia&#xD;
  &#xD;
            6. Any contraindications for TMS Implanted electronic device and non-removable metallic&#xD;
               objects near coil e.g., pacemaker, cochlear implant Presence of ferromagnetic metal in&#xD;
               the head outside the mouth On medication lowering seizure threshold&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>15 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sheffali Gulati</last_name>
      <role>Principal Investigator</role>
      <affiliation>All India Institute of Medical Sciences, New Delhi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sheffali Gulati</last_name>
      <phone>9810386847</phone>
      <email>sheffaligulati@gmail.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>All India Institute of Medical Sciences, New Delhi</investigator_affiliation>
      <investigator_full_name>Sheffali Gulati</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autistic Disorder</mesh_term>
      <mesh_term>Autism Spectrum Disorder</mesh_term>
      <mesh_term>Child Development Disorders, Pervasive</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06040775
  org study id: TBS-ASD
  nct id: NCT06040775
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  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
  Autism spectrum disorder (ASD) is a neurodevelopmental disorder with varying degrees of
        severity and symptoms with core deficits in social communication and interaction and
        repetitive behavior with restricted interests and activities -American Psychiatric
        Association, 2013. Diagnosis requires fulfilment of DSM V criterion for Autism Spectrum
        Disorder. ASD is a lifelong disorder with onset in early developmental period and most
        patients remain severely impaired in terms of psychosocial functioning throughout their adult
        lives.
  
        Need for exploration of newer treatment modalities - Currently there is no definitive
        treatment of Autism and for now the management strategies include - Applied Behavioral
        Analysis (ABA), sensory integration, and structured teaching targeting core deficits which
        are time taking process and labor intensive from both the caregiver and the provider's
        perspective. Pharmacotherapy is effective for targeting associated comorbidities like
        irritability, aggression, destructive behavior or hyperactivity and had the added
        disadvantage of side effects like sedation. For Complementary and Alternative Medicine
        strategies, proof of efficacy has not been unestablished for many. In this context
        Transcranial Magnetic Stimulation, TMS may prove to be a good non-invasive neuromodulation
        technique and could be an effective tool in the treatment of ASD core manifestations.
  
        Transcranial Magnetic Stimulation (TMS) is a non-invasive neuromodulation technique. It uses
        electromagnetic induction to generate transient, localized electrical fields in the brain
        cortex, causes depolarization and firing of local neurons. Acute effects of TMS include
        phasic activation of neural circuits and prolonged effects of TMS include alteration in
        Neuroplasticity by change in synaptic efficacy, leading to long term potentiation or
        long-term depression, this occurs via alteration in neurotropic factor, modulation of
        cortical excitability, modulation of functional connectivity. The current study aims to
        explore role of patterned TMS known as Theta Burst Stimulation (TBS)- in which pulses are
        applied in bursts of three, frequency of 50 Hz and an inter-burst interval of 200 milli
        seconds. TBS is a patterned form of repetitive transcranial magnetic stimulation (rTMS)
        modelled after endogenous hippocampal discharge patterns and has been shown to be more
        efficient than standard rTMS in modulating cortical excitability. The potential advantages of
        TBS over rTMS, particularly for children with ASD include shorter overall stimulation
        duration (5minutes in TBS). Also, TBS could be better tolerated overall and perhaps even
        safer than standard rTMS as sub threshold intensities are given for shorter periods. Effects
        of TBS on synaptic plasticity occur much more rapidly than with traditional repetitive TMS
        protocols. It is also less noisy due to lower amplitudes used which may reduce hyper sensory
        stimulation and may be one of the reasons why TBS could be better tolerated in children with
        ASD There seems to be converging in implication of role of dorsolateral prefrontal cortex in
        pathophysiology and aberrant neural circuitry of children with ASD. This study aims to study
        the effect of TBS as an adjunct to the ongoing standard therapy on core deficits in autism as
        measured by CY-BOCS - Children's Yale-Brown Obsessive Compulsive Scale, RBS-R - Repetitive
        Behavior Scale- Revised, social behavior change as measured by SRS-2 - Social Responsiveness
        Scale- version 2 and overall autistic traits using CARS-2 - Childhood Autism Rating Scale-
        version 2 at 1 month and 3 month from end of TBS sessions. It also aims to measure parent
        reported quality of life and adverse event rates participants. Change in cognitive function
        using Wisconsin card sorting and time to stroop will be used in participants with IQ>70.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Change in core function deficit in obsessive and repetitive behavior between intervention and control arm
  time frame: 4 weeks +/- 3 days from end of therapy
  description: 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
  measure: Change in core function deficit in social behavior and overall autism score between intervention and control arm
  time frame: 4 weeks +/- 3 days from end of therapy
  description: Difference in mean change in total Social Responsiveness Scale, Second Edition (SRS-2) and Childhood Autism Rating Scale, Second Edition (CARS-2) scores between intervention and control group
  SRS-2- Parent or teacher questionnaire (65 items on a 4- point Likert scale), Five domain scores ("Treatment Subscales"), Expressed as a raw score or a T-scores. Higher scores more severe social impairment CARS-2 -15 item scale, 1-4 in key areas related to autism diagnosis. For under 12 years of age, scores of 30 or above are indicative of autism and for students 12 years and older, scores of 28 or above are considered to be indicative of autism.
  measure: Change in core function deficit in social behavior and overall autism score between intervention and control arm
  time frame: 12 weeks +/- 7 days from end of therapy
  description: Difference in mean change in total CY-BOCS, RBS-R, SRS-2, CARS-2 scores 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 SRS-2- Parent or teacher questionnaire (65 items on a 4- point Likert scale), Five domain scores ("Treatment Subscales"), Expressed as a raw score or a T-scores. Higher scores more severe social impairment CARS-2 -15 item scale, 1-4 in key areas related to autism diagnosis. For under 12 years of age, scores of 30 or above are indicative of autism and for students 12 years and older, scores of 28 or above are considered to be indicative of autism.
  measure: Change in parent reported quality of life as assessed by PedsQL score between intervention and control arm
  time frame: 4 weeks +/- 3 days from end of therapy and 12 weeks +/- 7 days from end of therapy
  description: Difference in mean change in total Pediatric Quality of Life Inventory (PedsQL) score between intervention and control group
  measure: Describe Adverse events noted in intervention and control arm
  time frame: 4 weeks +/- 3 days from end of therapy
  description: Adverse event rate defined as ratio of sessions with adverse events divided by total sessions
  Adverse event will be defines as- positive increase in any of the ROS (review of systems) criteria compared to pre therapy (which will be filled at end of each therapy session)
  measure: To describe effect of TBS in Clinical test of cognition and executive function (in study population with IQ>70)
  time frame: at first visit, at 4 weeks +/- 3 days from end of therapy and at 12 weeks from end of therapy
  description: Wisconsin Card Sorting Test- Mean of change in total error score will be calculated for intervention and control arms Stroop test time- Total time to complete 3 paged stroop test (in seconds) will be compared
  arm group label: Theta burst transcranial magnetic stimulation arm
  arm group type: Experimental
  description: Theta burst transcranial magnetic stimulation with Applied Behaviour Analysis
  arm group label: Sham arm
  arm group type: Sham Comparator
  description: Sham transcranial magnetic stimulation with Applied Behaviour Analysis
  intervention type: Device
  intervention name: Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil
  description: 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
  arm group label: Theta burst transcranial magnetic stimulation arm
  other name: Applied Behavioral Analysis
  intervention type: Device
  intervention name: Sham magnetic stimulation using sham MCF-B65 coil
  description: 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
  arm group label: Sham arm
  other name: Applied Behavioral Analysis
  criteria: 
  gender: All
  minimum age: 5 Years
  maximum age: 15 Years
  healthy volunteers: No
  last name: Sheffali Gulati
  role: Principal Investigator
  affiliation: All India Institute of Medical Sciences, New Delhi
  last name: Sheffali Gulati
  phone: 9810386847
  email: sheffaligulati@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: All India Institute of Medical Sciences, New Delhi
  investigator full name: Sheffali Gulati
  investigator title: Professor
  mesh term: Autistic Disorder
  mesh term: Autism Spectrum Disorder
  mesh term: Child Development Disorders, Pervasive
  sharing ipd: No