CTRI/2023/11/059721
Not yet recruiting
Phase 3
Transcranial Direct Current Stimulation (tDCS) as an add on treatment for Restricted Repetitive Behaviour Domain of Autism Spectrum Disorder - an open label prospective study - NI
ational Institute of Mental Health and Neuro SciencesNIMHANS Bengaluru0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Institute of Mental Health and Neuro SciencesNIMHANS Bengaluru
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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