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CTRI Number  CTRI/2023/11/059721 [Registered on: 09/11/2023] Trial Registered Prospectively
Last Modified On: 26/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A study to understand the benefit of using novel interventions such as transcranial direct current stimulation for treating restricted repetitive behaviours in adolescents with autism spectrum disorder 
Scientific Title of Study   Transcranial Direct Current Stimulation (tDCS) as an add on treatment for Restricted Repetitive Behaviour Domain of Autism Spectrum Disorder - an open label prospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sakhardande Kasturi Atmaram 
Designation  DM Senior Resident Department of Child and Adolescent Psychiatry NIMHANS Bengaluru  
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS) 
Address  Department of Child and Adolescent Psychiatry NIMHANS Bengaluru 560029

Bangalore
KARNATAKA
560029
India 
Phone  08026995351  
Fax    
Email  drkasturi18@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr John Vijay Sagar K.  
Designation  Professor and Head 
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS) 
Address  Department of Child and Adolescent Psychiatry NIMHANS Bengaluru 560029

Bangalore
KARNATAKA
560029
India 
Phone  08026995351  
Fax    
Email  sagarjohn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sakhardande Kasturi Atmaram 
Designation  DM Senior Resident Department of Child and Adolescent Psychiatry NIMHANS Bengaluru  
Affiliation  National Institute of Mental Health and Neuro Sciences (NIMHANS) 
Address  Department of Child and Adolescent Psychiatry NIMHANS Bengaluru 560029

Bangalore
KARNATAKA
560029
India 
Phone  08026995351  
Fax    
Email  drkasturi18@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Mental Health and Neuro Sciences(NIMHANS), BENGALURU 
 
Primary Sponsor  
Name  National Institute of Mental Health and Neuro SciencesNIMHANS Bengaluru  
Address  DEPARTMENT OF CHILD AND ADOLESCENT PSYCHIATRY NIMHANS BENGALURU 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sakhardande Kasturi Atmaram   National Institute of Mental Health and Neurosciences( NIMHANS) BENGALURU  Department of Child & Adolescent Psychiatry, office room, 2 nd floor Adolescent Psychiatry Centre, NIMHANS
Bangalore
KARNATAKA 		 08026995351

drkasturi18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
InstitutionalEthicsCommitteeNIMHANSBengaluru  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F84||Pervasive developmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil   Nil  
Intervention  Transcranial direct current stimulation   Application of 2mA current- anodal stimulation of left Dorsolateral prefrontal cortex and cathodal stimulation of Supplementary motor area- for a duration of 20 mins, separated by a 20 mins interval - 2 sessions per day for 5 days 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Diagnosis of Autism spectrum disorder (DSM-5) and confirmed by INCLEN diagnostic tool;
2. Age 10-18 years;
3. Any sex;
4. Having clinically significant Restricted and repetitive behaviours, causing functional impairment;
5. Written informed consent of parents and informed assent from adolescents (>12 years).
 
 
ExclusionCriteria 
Details  1. Uncontrolled Seizure disorder/ Severe neurological illness/ structural brain disease;
2. Suicidal risk / any psychiatric emergency;
3. Exclusion of obsessive-compulsive disorder as aetiology for repetitive behaviours- via clinical evaluation.
4. Clinical diagnosis of severe - profound intellectual disability;
5. Acute mood / psychotic disorder (As RRBs could worsen during a symptomatic phase of comorbid psychiatric disorder);
6. Patients who are uncooperative for treatment due to aggression or severe behavioural issues.
7. Any Contraindication for Transcranial Direct Current Stimulation such as broken or abnormal skin at the site of electrode application, holes in the skull from trauma or surgery.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Reduction in Restricted repetitive behaviourseverity as measured on the Repetitive behaviour scale- revised  Baseline, 2 weeks, 6 weeks, 13 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in executive functioning as a mediator of improvement in RRBs  Baseline BRIEF tool assessment, followed by 2 weeks, 6 weeks & 13 weeks  
 
Target Sample Size   Total Sample Size="43"
Sample Size from India="43" 
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
Modification(s)  		 Phase 3 
Date of First Enrollment (India)   18/11/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drkasturi18@gmail.com].

  6. For how long will this data be available start date provided 31-12-2024 and end date provided 31-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Repetitive Restricted Behaviours(RRB) are an important clinical component of Autism spectrum disorder(ASD) and cause significant dysfunction in personal, social and occupational domains. Antipsychotic medications such as Risperidone and Aripiprazole though have some evidence for treatment; are however associated with adverse effects. Trancranial direct current stimulation(tDCS) is a safe intervention strategy with minimal side effects such as transient skin burning and has evidence of safety in children with ASD. On this background, the current study will be an open-labelled study evaluating the efficacy of anodal stimulation of left dorsolateral prefrontal cortex and cathodal stimulation of the supplementary motor area to target the higher-order as well as lower-order RRBs. Informed consent would be obtained from the parents and assent from adolescents older than 12 years of age. Adolescents in the age group of 10-18 years with ASD and dysfunctional RRBs will be recruited. The sessions would be carried out over a period of 5 working days with twice-a-day sessions of 20 minutes each and with an inter-session interval of 20 minutes. A current of 2mA will be administered. Baseline and follow-up assessments will include measures of RRB severity(Repetitive behaviour scale-revised), Autism treatment evaluation checklist, Developmental Disabilities modification of Children’s  Global Assessment Scale(DD-CGAS), and Behavior Rating Inventory of Executive Function-  parent version(BRIEF scale) to understand a mediator role of executive dysfunction.  
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