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Efficacy of Adjunctive Deep Transcranial Magnetic Stimulation in Mania and relation with Lactate/Creatinine ratio in Anterior Cingulate Cortex: a sham controlled 1H-MRS study

Efficacy of Adjunctive Deep Transcranial Magnetic Stimulation in Mania and relation with Lactate/Creatinine ratio in Anterior Cingulate Cortex: a sham controlled 1H-MRS study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056673
Enrollment
40
Registered
2023-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: F312- Bipolar disorder, current episodemanic severe with psychotic features Health Condition 2: F311- Bipolar disorder, current episodemanic without psychotic features Health Condition 3: F301- Manic episode without psychotic symptoms Health Condition 4: F302- Manic episode, severe with psychotic symptoms

Interventions

Intervention1: Deep Transcranial Magnetic Stimulation (dTMS), Active: The helmet with H7 dTMS coil will be placed on the head of the patient, adjusted so as to deliver the maximal stimulation to the A

Sponsors

Central Institute of Psychiatry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients fulfilling diagnosis of Bipolar type I disorder, current episode manic, with or without psychotic symptoms (6A60.0, 6A60.1) according to International Classification of Diseases 11th version (ICD-11)-Diagnostic Criteria for Research (DCR) by World Health Organization (WHO, 2022) 2.Either sex 18-60 years 3.Patients amenable to follow instructions 4.Right-handed normotensive patients 5.Patients giving written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients having BP > 140/90 mmHg 2.Diagnosis of any other psychiatric disorder, mental retardation, history of substantial brain damage, or any neurological or physical disorders 3.Patient with any substance dependence (except nicotine and caffeine) 4.Bipolar ?? disorder as according to International Classification of Diseases 11th version (ICD-11)-Diagnostic Criteria for Research (DCR) by World Health Organization (WHO, 2022) 5.Patients having any metallic implants/parts in body 6.Patients who had prior exposure to any mode of brain stimulation in last 6 months 7.Patient not giving informed consent

Design outcomes

Primary

MeasureTime frame
To assess efficacy of adjunctive active dTMS in improving symptoms of mania as assessed on YMRS, BPRS & CGI.Timepoint: at baseline, before first session & after tenth session of adjunctive dTMS between manic patients receiving active & sham treatment—

Secondary

MeasureTime frame
To find out the relationship of Lactate/creatinine ratio in Anterior Cingulate Cortex on 1H-MRS with efficacy of adjunctive active dTMS in mania.Timepoint: at baseline, before first session & after tenth session of adjunctive dTMS between manic patients receiving active and sham treatment—

Countries

India

Contacts

Public ContactDr Daya Ram

Central Institute of Psychiatry

dram_cip@rediffmail.com7856866667

Outcome results

None listed

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