| CTRI Number |
CTRI/2021/07/035267 [Registered on: 29/07/2021] Trial Registered Prospectively |
| Last Modified On: |
27/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Adjunctive dTMS for treatment of negative symptoms in Schizophrenia
|
|
Scientific Title of Study
|
Adjunctive Deep Transcranial Magnetic Stimulation (dTMS) for treatment of negative symptoms in schizophrenia A randomised sham controlled h-MRS study |
| Trial Acronym |
dTMS MRS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gulesh Kumar |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Room No. 44, Al Razi Post Graduate Hostel, Deptt. of psychiatry, Central Institute of Psychiatry, Kanke Ranchi Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
9050445524 |
| Fax |
|
| Email |
gulesh123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishant Goyal |
| Designation |
Associate Professor |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Incharge K.S. Mani CCN Lab, Central Institute of Psychiatry, Kanke Ranchi Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
9431171162 |
| Fax |
|
| Email |
Nishantgoyal.cip@gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniruddha Mukherjee |
| Designation |
Associate Professor |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Consultant Room, KS Mani CCN lab, Central Institute of Psychiatry, Kanke Ranchi Jharkhand
Ranchi
JHARKHAND
834006
India |
| Phone |
9474413598 |
| Fax |
|
| Email |
dr_aniruddha@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
central institute of psychiatry Ranchi Jharkhand |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Gulesh Kumar |
Central Institute of Psychiatry |
KS Mani CCN Lab and fMRI Centre, Psychiatry Department, Central Institute of Psychiatry, Kanke, Ranchi
Ranchi
JHARKHAND |
9050445524
gulesh123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Central Institute Of Psychiatry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 delivered to the ACC and the mPFC. Treatment will be delivered at 10 Hz with a train duration of 3 sec (for 40 trains per session). An inter train interval of 20 sec, and a total of 1,200 pulse per session. Total Duration - 10 sessions in two weeks (5 sessions per week). |
| Comparator Agent |
Deep Transcranial Magnetic Stimulation (dTMS), Sham |
The helmet of H7 coil has an in-built system to deliver sham stimulation. The helmet will be placed over the head of the patient and the sham protocol is selected from the dTMS system. This delivers local sensations through very low intensity electric currents and also generates noise identical to the active stimulation. But this generates no magnetic field or substantial electric field which might stimulate the underlying brain regions. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Schizophrenia using Diagnostic Criteria for Research (DCR) of International
Classification of Disease-10th edition (ICD-10, World Health Organization, 1992).
2. Age between 18- 60 years of either sex.
3. Illness duration of equal to or more than 2 years.
4. The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) negative symptoms score
of more than 15.
5. Scale for Assessment of Negative Symptoms (SANS) score more than 20.
6. Calgary Depression Scale for Schizophrenia (CDSS) score less than 7.
7. Right-handed.
8. Patients giving written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Presence of co-morbid neurological or other psychiatric disorder(s).
2. Patient with co morbid substance dependence, except nicotine and caffeine.
3. Having any metallic implants/parts in body.8
4. Subjects who have received ECT in past 6 months. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome of this study is the change in negative symptoms score as assessed at the end of 2 weeks
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
|
| Outcome |
TimePoints |
| 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. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "54"
Final Enrollment numbers achieved (India)="54" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2021 |
| Date of Study Completion (India) |
31/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Negative
symptoms are important when it comes to prognosis and outcomes of
schizophrenia. Both typical and atypical antipsychotics have shown limited
effectiveness 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 further
in response to increasing task demands (Adams and David, 2007; Bersani et al., 2014). Manoach (2003) has described this relationship
in the dorsolateral prefrontal cortex (DLPFC) in schizophrenia, and relates
task-related DLPFC hypoactivity to decreased task performance. Considering the
hypoactivity in these parts in schizophrenia, particularly with negative
symptoms, activation of these structure can lead to the improvement in in
negative symptoms, as reported by Dlabac-de Lange
et al in 2010, where they reported a significant superiority of active rTMS
(DLPFC) over sham to reduce negative symptoms of schizophrenia (Dlabac-de Lange
et al., 2010). Moreover, negative symptoms are related to specific
neuroanatomical changes specially to mPFC and ACC. Compared to conventional
method of TMS, dTMS have an advantage of stimulating deeper structures. Results
of studies using dTMS for the treatment of negative symptoms and cognitive
deficits have shown a positive therapeutic effect when used as an adjunct to
antipsychotic agents. In a study seventy percent of patients who completed
treatment were responders, having achieved >20% improvement in negative
symptoms. (Levkovitz et al.,2011). To the best of our knowledge, there has been
no study assessing the effects of dTMS in negative symptoms of schizophrenia as
measured by H-MRS findings of mPFC and ACC. |