| CTRI Number |
CTRI/2019/02/017568 [Registered on: 08/02/2019] Trial Registered Prospectively |
| Last Modified On: |
27/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Transcranial Magnetic Stimulation in children with Autism Spectrum Disorder |
|
Scientific Title of Study
|
Study to determine efficacy of repetitive Transcranial Magnetic Stimulation (RTMS) in children with Autism Spectrum Disorder: A Randomised Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vishal Sondhi |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Pediatrics,
Armed Forces Medical College,
Solapur Road
Pune
MAHARASHTRA
411040
India |
| Phone |
9560664032 |
| Fax |
|
| Email |
vishalsondhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vishal Sondhi |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Pediatrics,
Armed Forces Medical College,
Solapur Road
Pune
MAHARASHTRA
411040
India |
| Phone |
9560664032 |
| Fax |
|
| Email |
vishalsondhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vishal Sondhi |
| Designation |
Associate Professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Pediatrics,
Armed Forces Medical College,
Solapur Road
Pune
MAHARASHTRA
411040
India |
| Phone |
9560664032 |
| Fax |
|
| Email |
vishalsondhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Defense Research & Development Organization
Metcalfe House
Delhi
110054 |
|
|
Primary Sponsor
|
| Name |
Vishal Sondhi |
| Address |
Assistant Professor,
Department of Pediatrics,
Armed Forces Medical College,
Sholapur Road,
Pune-411040 |
| Type of Sponsor |
Other [PI is the primary Sponsor] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vishal Sondhi |
Armed Forces Medical College |
Department of Pediatrics,
Armed Forces Medical College,
Sholapur Road
Pune
MAHARASHTRA |
9560664032
vishalsondhi@gmail.com |
| JN Goswami |
Army Hospital (R&R) |
Army Hospital (Research & Referral)
Dhaula Kuan
New Delhi
New Delhi
DELHI |
8727993888
jngswami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham Therapy |
Children included in Group B shall be delivered sham therapy as per protocol B.
Pre-therapeutic preparation:
(a) Clinical evaluation by investigator with emphasis on vital parameters, hydration status
(b) Sedation, if required, would be given under supervision with syrup Trichlofos in appropriate dosage as per weight (unless if contraindicated)
Protocol B:
(a) Sham stimulation using sham probe.
(b) Duration: 10 min
(c) This protocol would be given weekly for 12 weeks
Whatever institutional and/or home-based therapy the child is receiving at the onset of trial would continue as per schedule.
|
| Intervention |
Transcranial Magnetic Stimulation |
Pre-Intervention preparation:
(a) Clinical evaluation by investigator with emphasis on vital parameters, hydration status
(b) Sedation, if required, would be administered (under supervision) with syrup Trichlofos in appropriate dosage as per weight (unless contraindicated)
Intervention Protocol :
(a) Site: Dorsolateral Prefrontal Cortex (DLPFC) (bilateral)
(b) Frequency: 0.5Hz
(c) Intensity:80% of Resting Motor Threshold (RMT)
(d) Duration:10 min
(e) This intervention protocol would be delivered once weekly for 12 weeks
Whatever institutional and/or home-based therapy the child is receiving at the onset of trial would continue as per schedule.
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
(a) Indian Scale for Assessment of Autism Scores 70 or more
(b) Either parent should be willing and capable of following instructions and maintaining activity log |
|
| ExclusionCriteria |
| Details |
(a) History of seizure(s) in child or immediate (1st degree relative) family
(b) Abnormal EEG
(c) Secondary autism (as a co-morbidity of structural brain lesion, metabolic cause etc)
(d) Children with concomitant chronic systemic illnesses that can interfere with administration of intervention
(e) Children with any acute illness
(f) Children with history of fainting spells
(g) Children with metallic implants, pacemaker, VP shunt, Vagal Nerve Stimulator, Deep Brain Stimulator
(h) Dysmorphism involving head
(i) History of severe head injury
(j) Progressive neurological illness
(k) Children on medicines that decrease seizure threshold (eg. Baclofen)
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autism≥ 70) managed with repetitive Transcranial Magnetic Stimulation (rTMS) once a week for twelve weeks with those managed with identical dosage of placebo, for change in Childhood Autism Rating Scale-2 (CARS-2) scores at 12 weeks of completion of intervention |
At 12 weeks of completion of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autism ≥ 70) managed with repetitive Transcranial Magnetic Stimulation (rTMS) once a week for twelve weeks with those managed with identical dosage of placebo, for change inSocial Communication Questionnaire (SCQ) Scores
|
12 weeks from completion of rTMS |
To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autism ≥ 70) managed with repetitive Transcranial Magnetic Stimulation (rTMS) once a week for twelve weeks with those managed with identical dosage of placebo, for change in
Indian Scale for Assessment of Autism Scores at 12 wks of completion of intervention |
12 wks of completion of intervention |
To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autism ≥ 70) managed with repetitive Transcranial Magnetic Stimulation (rTMS) once a week for twelve weeks with those managed with identical dosage of placebo, for change into compare the change in the Childhood Autism Rating Scale-2 (CARS-2) scores between children in the two groups at 6 months of completion of intervention.
|
6 months of completion of intervention |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
BackgroundAutism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by varying degrees of maladaptive social interaction, poor language (verbal and nonverbal) and repetitive, restrictive behaviors. The incidence of ASD ranges between 1-2% worldwide. ASD is diagnosed clinically, based on the presence of key behavioral symptoms, but the underlying brain mechanisms causing these symptoms are unknown and there currently exists no cure. Most empirically supported treatments for the core symptoms of ASD focus on early intensive behavioral interventions (Reichow, 2012). Pharmacological treatments are at times effective in treating secondary and comorbid features of ASD, such as aggression or hyperactivity and attention deficit, or epilepsy (Hampson, Gholizadeh, & Pacey, 2012), but there is currently no pharmacotherapy shown to effectively treat the core symptoms of ASD. Transcranial Magnetic Stimulation is a novel technique of non-invasive focal brain stimulation and creation of focal electric fields causing neuromodulation. Through a process of electromagnetic induction, it generates rapid pulse of electrical current that induces a rapidly fluctuating magnetic field, which in turn induces an electrical current in the underlying brain tissue (Barker, Jalinous, & Freeston, 1985; Wagner, Valero-Cabre, & Pascual-Leone, 2007). The potential of rTMS to induce a long-lasting modulation of cortical excitability and plasticity offers the possibility of its use for therapeutic purposes in neurological and psychological conditions thought to be a result of altered excitability or plasticity of specific neural circuits. There is growing interest in the possible role of TMS for diagnosing and treating ASD. There are preliminary data suggesting an improvement in both physiological indices and specific behavioral symptoms in children with ASD following rTMS. However, its definite efficacy, regime, dosage and duration are grey areas requiring standardization. Hence, this randomized trial is being undertaken to study the hypothesis that among 6-16 years old children with ASD, once a week rTMS for twelve weeks will result in better improvement in behavioral symptoms as measured by Childhood Autism Rating Scale-2 (CARS-2) scores, at 12 weeks, as compared to sham therapy. |