Autism Spectrum DisorderNCT06040775
Evaluation of Theta Burst Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorder
A study testing Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil in people with Autism Spectrum Disorder, run by All India Institute of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 5 to 15 year age.
- Fulfills DSM-V diagnosis of autism spectrum disorder (ASD)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the detailed description
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil, Sham magnetic stimulation using sham MCF-B65 coil
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coilDevice
Also called Applied Behavioral Analysis
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
Sham magnetic stimulation using sham MCF-B65 coilDevice
Also called Applied Behavioral Analysis
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
| Study group | Role | What they receive |
|---|---|---|
| Theta burst transcranial magnetic stimulation arm | Experimental | Theta burst transcranial magnetic stimulation with Applied Behaviour Analysis Receives: Device: Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil |
| Sham arm | Sham comparator | Sham transcranial magnetic stimulation with Applied Behaviour Analysis Receives: Device: Sham magnetic stimulation using sham MCF-B65 coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: 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
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.
Measured: 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
Difference in mean change in total Pediatric Quality of Life Inventory (PedsQL) score between intervention and control group
Measured: 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
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)
Measured: 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)
Wisconsin Card Sorting Test- Mean of change in total error score will be calculated for intervention and control arms
Measured: at first visit, at 4 weeks +/- 3 days from end of therapy and at 12 weeks from end of therapy
To describe effect of TBS in clinical tests for executive function using Stroop test time(in study population with IQ>70)
Stroop test time- Total time to complete 3 paged stroop test (in seconds) will be compared or intervention and control arms
Measured: at first visit, at 4 weeks +/- 3 days from end of therapy and at 12 weeks from end of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start15 Sep 2023 (estimated)
- Primary completion15 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheffali Gulati, All India Institute of Medical Sciences
- Investigators
- Sheffali Gulati, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040775
- Sponsor's protocol ID
- TBS-ASD
- Status last verified
- Sep 2023
- First submitted
- 3 Jul 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06040775
- Acronym / sponsor ID
- TBS-ASD
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Study start
- 15 Sep 2023 (estimated)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theta burst transcranial magnetic stimulation arm | Experimental | Device: Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coilTheta burst transcranial magnetic stimulation with Applied Behaviour Analysis |
| Sham arm | Sham comparator | Device: Sham magnetic stimulation using sham MCF-B65 coilSham transcranial magnetic stimulation with Applied Behaviour Analysis |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 5 to 15 year age.
- Fulfills DSM-V diagnosis of autism spectrum disorder (ASD)
Key exclusion criteria (9 listed)
- Secondary causes of autism
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coilAlso: Applied Behavioral AnalysisSite 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 | Theta burst transcranial magnetic stimulation arm |
| Sham magnetic stimulation using sham MCF-B65 coilAlso: Applied Behavioral AnalysisSimilar 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 | Device | Sham arm |
Primary outcome
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
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
6 secondary outcomes
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
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
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
Describe Adverse events noted in intervention and control arm
Time frame: 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)
Time frame: at first visit, at 4 weeks +/- 3 days from end of therapy and at 12 weeks from end of therapy
To describe effect of TBS in clinical tests for executive function using Stroop test time(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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheffali Gulati principal investigator
All India Institute of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Theta Burst Transcranial magnetic Stimulation using real MCF-B65 coil in people with Autism Spectrum Disorder, run by All India Institute of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheffali Gulati (9810386847, sheffaligulati@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.