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

Not yet recruiting

Conditions: Manic episode without psychotic symptoms, (2) ICD-10 Condition: F302||Manic episode, severe with psychotic symptoms, (3) ICD-10 Condition: F311||Bipolar disorder, current episodemanic without psychotic features, (4) ICD-10 Condition: F312||Bipolar disorder, current episodemanic severe with psychotic features,

Registration Number: CTRI/2023/08/056673

Lead Sponsor: Central Institute of Psychiatry

Brief Summary: Many patients with bipolar disorder, fail to experience benefit even after adequate

pharmacotherapy (Geddes and Miklowitz,2013). For the patients who do respond to

pharmacotherapy, many experience frequent and intolerable side effects leading to

medication non-adherence or discontinuation (Matson et al,2006; Shah et al.,2017) or suffer

from an increased medical burden along with added problems of interactions among

medications for co-morbid illnesses (Kemp et al,2014; Martin et al.,2005). Therefore, the

limitations of pharmacotherapy suggest the importance of alternative treatment options that

will help patients with bipolar disorder achieve and sustain remission (Martin et al,2005).

There have been few studies on neuromodulation in mania. TMS studies in mania are few

and mainly include traditional protocols targeting the right prefrontal region, stemming from

an early clinical trial by Grisaru et al.,1998. Another study by Kaptsan et al.,2003 along

similar lines to the previous study reported no difference between right-sided and sham TMS,

proposing more intensive protocol for mania. To date, only one randomized study has

suggested the potential benefit of a rTMS protocol over the right DLPFC for mania (Praharaj

et al.,2009).

However, to the best of our knowledge, no previous study has examined the efficacy of

dTMS targeting the ACC and mPFC in mania, or has examined the correlation of efficacy of

dTMS of mania with Lactate/Creatinine ratio in ACC on 1H-MRS study.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

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

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 Ð†Ð† 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess efficacy of adjunctive active dTMS in	at baseline, before first \| session & after tenth session of adjunctive dTMS between manic patients receiving \| active & sham treatment
improving symptoms of mania as assessed on YMRS, BPRS & CGI.	at baseline, before first \| session & after tenth session of adjunctive dTMS between manic patients receiving \| active & sham treatment

Secondary Outcome Measures

Name	Time	Method
To find out the relationship of Lactate/creatinine	ratio in Anterior Cingulate Cortex on 1H-MRS with efficacy of adjunctive active dTMS in

Trial Locations

Locations (1): Central Institute of Psychiatry
🇮🇳
Ranchi, JHARKHAND, India
Central Institute of Psychiatry
🇮🇳Ranchi, JHARKHAND, India
Dr Bipasha Karak
Principal investigator
9674767396
bipashakarak@gmail.com