| CTRI Number |
CTRI/2024/11/077351 [Registered on: 26/11/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Combining rTMS and Parental Training to Improve Outcomes in Children with Autism: A Randomized Trial |
|
Scientific Title of Study
|
Effect of rTranscranial Magnetic Stimulation rTMS along with parental behavioural training in children with autism spectrum syndrome A Randomized controlled trial |
| 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 Sharath Hullumani V |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Room No. 142 , Ground Floor, Department of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi Meghe
Wardha
MAHARASHTRA
442004
India |
| Phone |
9964066927 |
| Fax |
|
| Email |
sharathhullumani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raghuveer Raghumahanti |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Department of Neurophysiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi (Meghe)
Wardha
MAHARASHTRA
442004
India |
| Phone |
8126506769 |
| Fax |
|
| Email |
raghuneuro@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharath Hullumani V |
| Designation |
Assistant Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU) |
| Address |
Room No. 142 , Ground Floor, Department of Paediatric Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research (DU), Sawangi Meghe
Wardha
MAHARASHTRA
442004
India |
| Phone |
9964066927 |
| Fax |
|
| Email |
sharathhullumani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research (DU), Sawangi Meghe, Wardha-42001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research DU |
| Address |
Department of Physiotherapy, Acharya Vinoba Bhave Rural Hospital,Sawangi Meghe ,Wardha-442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharath Hullumani |
Acharya Vinoba Bhave Rural Hospital |
Room No.10, Department of Neuro Physiotherapy, Datta Meghe Institute of Higher Education and Research (DU),Sawangi Meghe.
Wardha
MAHARASHTRA
Wardha
MAHARASHTRA |
9964066927
sharathhullumani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Institute of Higher Education & Research [Deemed to be University] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
The control group will be receiving their standard physiotherapy protocol to the contralateral side for one hour each day, 5 days per week for 4 weeks. |
| Intervention |
rTRNM |
Intermittent theta burst stimulation ( iTBS) parameters were based on the standard ITBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 80% active motor threshold, 30 minutes each day, 5 days per week for 4 weeks During ITBS, 2-s trains of bursts were repeated every 10 seconds for a total of 192 s with 600 pulses |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Stable Medication Regimen
Willingness to Participate
Adequate Communication Skills |
|
| ExclusionCriteria |
| Details |
Other Neurodevelopmental Disorders
Contraindications to rTMS
Unstable Psychiatric or Medical Conditions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Indian Scale for Assessment of Autism |
Baseline, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Child Behavior Checklist |
Baseline, 4th week |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/12/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sharathhullumani@gmail.com].
- For how long will this data be available start date provided 07-09-2024 and end date provided 07-09-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
In children with Autism Spectrum Syndrome, does the combined intervention of transcranial magnetic stimulation (rTMS) and parental behavioral training yield superior behavioral, social, and neurobiological outcomes compared to standard care or an alternative intervention |