Adjunctive dTMS for treatment of negative symptoms in Schizophrenia

Completed

Conditions: Schizophrenia,

Registration Number: CTRI/2021/07/035267

Lead Sponsor: Central Institute of Psychiatry

Brief Summary: Negativesymptoms are important when it comes to prognosis and outcomes ofschizophrenia. Both typical and atypical antipsychotics have shown limitedeffectiveness in modifying the psychopathology of negative symptoms.Hypo-activation of the ACC are found in neuroimaging studies of schizophrenia.It could be that an abnormal ACC in schizophrenia is unable to activate furtherin response to increasing task demands (Adams and David, 2007; Bersani et al., 2014). Manoach (2003) has described this relationshipin the dorsolateral prefrontal cortex (DLPFC) in schizophrenia, and relatestask-related DLPFC hypoactivity to decreased task performance. Considering thehypoactivity in these parts in schizophrenia, particularly with negativesymptoms, activation of these structure can lead to the improvement in innegative symptoms, as reported by Dlabac-de Langeet al in 2010, where they reported a significant superiority of active rTMS(DLPFC) over sham to reduce negative symptoms of schizophrenia (Dlabac-de Langeet al., 2010). Moreover, negative symptoms are related to specificneuroanatomical changes specially to mPFC and ACC. Compared to conventionalmethod of TMS, dTMS have an advantage of stimulating deeper structures. Resultsof studies using dTMS for the treatment of negative symptoms and cognitivedeficits have shown a positive therapeutic effect when used as an adjunct toantipsychotic agents. In a study seventy percent of patients who completedtreatment were responders, having achieved >20% improvement in negativesymptoms. (Levkovitz et al.,2011). To the best of our knowledge, there has beenno study assessing the effects of dTMS in negative symptoms of schizophrenia asmeasured by H-MRS findings of mPFC and ACC.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

Diagnosis of Schizophrenia using Diagnostic Criteria for Research (DCR) of International Classification of Disease-10th edition (ICD-10, World Health Organization, 1992).
Age between 18- 60 years of either sex.
Illness duration of equal to or more than 2 years.
The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) negative symptoms score of more than 15.
Scale for Assessment of Negative Symptoms (SANS) score more than 20.
Right-handed.
Patients giving written informed consent.

Exclusion Criteria

Presence of co-morbid neurological or other psychiatric disorder(s).
Patient with co morbid substance dependence, except nicotine and caffeine.
Having any metallic implants/parts in body.8 4.
Subjects who have received ECT in past 6 months.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome of this study is the change in negative symptoms score as assessed at the end of 2 weeks	Primary outcome of this study is the change in negative symptoms score as assessed at the end of 2 weeks \| of dTMS treatment.
of dTMS treatment.	Primary outcome of this study is the change in negative symptoms score as assessed at the end of 2 weeks \| of dTMS treatment.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are changes in the levels of GABA, Glutamate, Glutamine, N-Acetyl Aspartate & N-Acetyl Aspartyl Glutamate in Medial Prefrontal Cortex and Anterior Cingulate Cortex using Proton MR Spectroscopic imaging and overall severity scores on CGI.	Secondary outcomes are changes in the levels of GABA, Glutamate, Glutamine, N-Acetyl Aspartate & N-Acetyl Aspartyl Glutamate in Medial Prefrontal Cortex and Anterior Cingulate Cortex using Proton MR Spectroscopic imaging and overall severity scores on CGI, will be assessed at end of 2 weeks of dTMS treatment.

Trial Locations

Locations (1): Central Institute of Psychiatry
🇮🇳
Ranchi, JHARKHAND, India
Central Institute of Psychiatry
🇮🇳Ranchi, JHARKHAND, India
Gulesh Kumar
Principal investigator
9050445524
gulesh123@gmail.com