Health Condition 1: F59- Unspecified behavioral syndromes associated with physiological disturbances and physical factors
Conditions
Interventions
None listed
Sponsors
ENKEL TECHNOLOGY
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 3-10 years 2. Parents/caretaker willing to provide informed consent 3. Clinical diagnosis of autism spectrum disorder by DSM-5 criteria 4. Level 1 and 2 DSM V autism severity levels
Exclusion criteria
Exclusion criteria: 1. Patient weighing less than 13kg (28.6 lbs) 2. Previous history of severe head trauma or stroke, loss of consciousness, seizure (or need for seizure medication either present or past) within one year of entering study or uncontrolled systemic disease. 3. Unstable or severe psychiatric/neurological disorders. 4. History of epilepsy or seizure disorder (except for history of simple febrile seizures or if the child is seizure free (regardless of seizure type) for the one year). 5. Motor or sensory impairment that would interfere with the valid completion of study measures including significant hearing or vision impairment not correctable by a hearing aid or glasses/contact lenses. Children who wear bifocal or progressive lenses are not eligible. 6. Seizures within the past one year. 7. Significant gastrointestinal issues or other severe medical conditions. 8. Severe co-morbid conditions (e.g. psychosis, epilepsy uncontrolled by medication, presence of severe visual or hearing impairment) that may interact with study procedures 9. Any other factor that the investigator feels would make assessment or measurement performance invalid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Suprabrain for 12 weeks in children with autism spectrum disorder aged 3-10 yearsTimepoint: To evaluate the efficacy of Suprabrain for 12 weeks in children with autism spectrum disorder aged 3-10 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in sleep problemsTimepoint: Change in Childhood sleeping scale score at 12 weeks;Improvement in repetitive BehaviourTimepoint: Change in RBS-EC score;To establish safety of the Suprabrain Timepoint: Nature and frequency of adverse events measured by CTCAE grading | — |
Countries
India
Contacts
Public ContactDr Rajesh Sehgal
AIIMS, Rishikesh
Outcome results
None listed