Health Condition 1: F840- Autistic disorder
Conditions
Interventions
Intervention1: Transcranial Magnetic Stimulation: Pre-Intervention preparation:
(a) Clinical evaluation by investigator with emphasis on vital parameters, hydration status
(b) Sedation, if required,
Sponsors
Vishal Sondhi
Eligibility
Inclusion criteria
Inclusion criteria: (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
Exclusion criteria
Exclusion criteria: (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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autismâ?¥ 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 interventionTimepoint: At 12 weeks of completion of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare 6-16-year-old children and adolescents with Autism Spectrum Disorder (ASD) (Indian Scale for Assessment of Autism â?¥ 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 interventionTimepoint: 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 â?¥ 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 Timepoint: 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 â?¥ 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. Timepoint: 6 months of completion of intervention | — |
Countries
India
Contacts
Public ContactVishal Sondhi
Armed Forces Medical College
Outcome results
None listed