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Comparing efficacy of precision and conventional interventional neuromodulation in patients with young onset mania by using scales, neuroimaging and Transcranial Magnetic Stimulation parameters

Efficacy of precision-based HD-tDCS over conventional HD-tDCS as measured by functional neuroimaging and cortical inhibition paradigms in young-onset mania: An active comparison study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/02/080567
Enrollment
40
Registered
2025-02-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: F30- Manic episode Health Condition 2: F31- Bipolar disorder

Interventions

Intervention1: Precision based High-definition transcranial Direct Current Stimulation (HD-tDCS): The interventional group would receive precision-based High-definition transcranial Direct Current Sti

Sponsors

Central Institute Of Psychiatry Ranchi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of Bipolar type I disorder (6A60) with current episode manic according to the International Classification of Diseases, Eleventh Revision (ICD-11) (WHO, 2019). 2. The age of onset of mania less than 18 years of age belonging to either sex. 3. The current age of the patient is between 10 to 20 years of age. 4. Written informed assent/consent on behalf of participant, parents, guardians or caregivers as applicable.

Exclusion criteria

Exclusion criteria: 1. Presence of comorbid other psychiatric or neurological disorders. 2. History of major medical illness. 3. History of epilepsy, sustained brain damage or any neurological procedures. 4. Subjects who have received ECT/rTMS in the past two months. 5. Developmental delay or mental retardation. 6. Any contraindication to undergo fMRI, TMS or HD-tDCS 7. Mixed episodes of depression and mania measured as a score of more than six on HAM-D

Design outcomes

Primary

MeasureTime frame
Improvement of symptoms of young onset mania, as measured by YMRS Score and severity of illness, as measured by CGI scores after receiving adjunctive precision-based HD-tDCS.Timepoint: Primary outcomes are assessed 2 and 6 weeks after intervention.

Secondary

MeasureTime frame
Improvement of functional connectivity, as measured by neuroimaging and enhancement of cortical inhibition as measured by cortical inhibition paradigms in young onset mania after receiving adjunctive precision-based HD-tDCS.Timepoint: Secondary outcomes are assessed 2 and 6 weeks after intervention.

Countries

India

Contacts

Public ContactProf Dr Sourav Khanra

CENTRAL INSTITUTE OF PSYCHIATRY, RANCHI

psynishant@gmail.com9431171162

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026