SAFETY AND EFFICACY OF ADJUNCTIVE dTMS FOR MANAGEMENT OF EMOTIONAL DYSREGULATION IN CHILDREN AND ADOLESCENTS WITH EXTERNALISING BEHAVIOR DISORDERS
- Conditions
- Health Condition 1: F90-F98- Behavioral and emotional disorders with onset usually occurring in childhood and adolescence
- Registration Number
- CTRI/2023/03/050701
- Lead Sponsor
- Central Institute of psychiatry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Children and Adolescents scoring above the cut off for externalizing behaviour as measured by CBCL further diagnosed with DSM V for attention deficit/ hyperactivity disorder (ADHD), Oppositional Defiant Disorder (ODD) and Conduct disorder, Disruptive mood dysregulation disorder, Mood disorders (except for those having psychotic symptoms) and Substance use.
2.Both gender from 8 years to less than 18 years of age.
3.Children and Adolescents providing assent/consent and written informed consent provided by parents/caregivers for the study
1.Children and adolescents with history of chronic or other significant general medical/ neurological Illness.
2.Children and adolescents with history of any psychosis.
3.Children and adolescents who had prior exposure to any mode of brain stimulation in last 6 months.
4.Having any metallic implants/parts in body.
5.Children and adolescents who are falling below average in intellectual functioning. (At or below 25 percentiles on SPM)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety of deep TMS in Children and adolescent population as assessed by TMSens_Q and reduction in scores on Child Behaviour Checklist (CBCL) and Difficulties in Emotion Regulation Scale (DERS).Timepoint: Primary outcome variable will be Safety of deep TMS in Children and adolescent population as assessed by TMSens_Q and reduction in scores on Child Behaviour Checklist (CBCL) and Difficulties in Emotion Regulation Scale (DERS) after 3 weeks of dTMS treatment.
- Secondary Outcome Measures
Name Time Method fMRI task-based assessment of difference in functional connectivity between mPFC and ACC at baseline and after application of dTMS and reduction in scores of Barrettâ??s Impulsivity scale, Modified overt aggression scale and Severity of clinical global inventory. <br/ ><br> <br/ ><br>Timepoint: Secondary outcome variables are fMRI task-based assessment of difference in functional connectivity between mPFC and ACC at baseline and after application of dTMS and reduction in scores of Barrettâ??s Impulsivity scale, Modified overt aggression scale and Severity of clinical global inventory after 3 weeks of dTMS teatment. <br/ ><br> <br/ ><br>