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SAFETY AND EFFICACY OF ADJUNCTIVE dTMS FOR MANAGEMENT OF EMOTIONAL DYSREGULATION IN CHILDREN AND ADOLESCENTS WITH EXTERNALISING BEHAVIOR DISORDERS

SAFETY AND EFFICACY OF ADJUNCTIVE DEEP TRANSCRANIAL MAGNETIC STIMULATION (dTMS) FOR MANAGEMENT OF EMOTIONAL DYSREGULATION IN CHILDREN AND ADOLESCENTS WITH EXTERNALISING BEHAVIOR DISORDERS: A TRANSDIAGNOSTIC SHAM CONTROLLED fMRI STUDY

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050701
Enrollment
40
Registered
2023-03-15
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F90-F98- Behavioral and emotional disorders with onset usually occurring in childhood and adolescence

Interventions

Intervention1: Deep transcranial magnetic stimulation (dTMS), active: The helmet with H7 dTMS coil will be placed on the head of the patient. It will be adjusted such that, the maximal stimulation is

Sponsors

Central Institute of psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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. 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.

Countries

India

Contacts

Public ContactDr Nishant Goyal

Central institute of psychiatry

psynishant@gmail.com9431171162

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026