Condition category
Mental and Behavioural Disorders
Date applied
28/05/2020
Date assigned
08/06/2020
Last edited
06/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Schizophrenia is a common mental illness that can cause symptoms such as hearing voices and seeing visual hallucinations. Schizophrenia is a lifelong illness that often fails to respond to standard antipsychotic medications or is only partially responsive to the currently available medications. For treatment-resistant schizophrenia patients, there is an urgent need to develop new effective treatments.

Transcranial magnetic stimulation is a noninvasive procedure that uses a coil to generate magnetic fields to stimulate nerve cells in the brain. Evidence suggests that transcranial magnetic stimulation can reduce symptoms of schizophrenia, although trials to date have been limited to a small number of patients and the overall results have been mixed.

The cerebellum is a part of the brain that coordinates voluntary movements such as eye movements, posture, balance, coordination, and speech. Cerebellar abnormalities have been seen in patients with symptoms of schizophrenia, so, therefore, could be a potential therapeutic target for the treatment of schizophrenia. Although the relation of the cerebellar vermis, a part of the cerebellum, to schizophrenia is not clear, it is seen to be smaller in patients with chronic schizophrenia than those without. There has been shown to be short term significant improvement in some symptoms in schizophrenia when high-frequency magnetic stimulation was delivered to the cerebellar vermis.

This study aims to test whether stimulating the cerebellar vermis, using intermittent transcranial magnetic stimulation, can improve the symptoms of schizophrenia in patients with treatment-resistant schizophrenia.

Who can participate?
Adult patients with a diagnosis of treatment-resistant schizophrenia

What does the study involve?
Participants will be randomly allocated to receive either transcranial magnetic stimulation using a ''Figure of 8 coil'' or a placebo treatment that uses a similar looking coil that does not give magnetic stimulation. For both groups of participants, there will be 2 sessions each day (half an hour apart) for 5 days over 1 week. Each session will last around 3 mins. Participants will have an assessment of their schizophrenia symptoms at the start of the study and these measurements will be repeated at 7 and 21 days

What are the possible benefits and risks of participating?
There are no serious or long-term side effects anticipated. Some participants may develop a headache for which pain relief will be provided.

Where is the study run from?
Shri Guru Ram Rai Institute (India)

When is the study starting and how long is it expected to run for?
From 2019 to 2020

Who is funding the study?
Shri Guru Ram Rai Institute (India)

Who is the main contact?
Dr Preeti Chauhan
dr.preetichauhan29@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Preeti Chauhan

ORCID ID

http://orcid.org/0000-0002-1512-9152

Contact details

Department of Psychiatry
Shri Guru Ram Rai Institute of Medical and Health Sciences
Dehradun
248001
India
+91 9582774305
dr.preetichauhan29@gmail.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

SGRR/IEC/1/19

Study information

Scientific title

Efficacy of adjunctive intermittent theta-burst transcranial magnetic stimulation for treatment-resistant schizophrenia: a randomized placebo-controlled study

Acronym

Study hypothesis

There will be significant difference in percentage of change in positive, negative and cognitive symptoms following active intermittent theta burst stimulation as compare to placebo stimulation.

Ethics approval

Approved 03/05/2019, Institutional Ethics Committee of Shri Guru Ram Rai Institute of Medical and Health Sciences (Adminstrative building, Patel nagar, Dehradun 248 001 India; +91 0135 2522100; smi.hospital@gmail.com), ref: SGRR/IEC/1/19

Study design

Single-centre, double-blind, placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Treatment-resistant schizophrenia

Intervention

Participants will be randomized using a lottery method to receive either the intervention of intermittent theta burst transcranial magnetic stimulation to the cerebellar vermis or placebo control.

Intervention arm
Intermittent theta-burst transcranial magnetic stimulation is a non-invasive form of brain stimulation in which a changing magnetic field is used to generate an electric current in a specific area brain (in this trial, the cerebellum-vermis) through electromagnetic stimulation. The MagVenture-MagPro-R30 will be used for stimulation using a coil figure of 8. Participants will receive 2 sessions each day (half an hour apart) for 5 days over 1 week, each session will last around 3 mins, with 600 pulses administered over the cerebellum.

Control arm:
The placebo control will involve the same schedule of Participants will receive 2 sessions each day (half an hour apart) for 5 days over 1 week, and each session will last around 3 mins, but will use the opposite side of Figure of 8 coil use so will not stimulate electrical activity in the brain.

Prior to the intervention participants' schizophrenia symptoms will be assessed and these measurements will be repeated at 7 and 21 days

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Schizophrenia symptoms measured using the Positive And Negative Symptoms Scale rating done at 0, 7, 21 days

Secondary outcome measures

Schizophrenia symptoms measured using the following at 0, 7, 21 days:
1. Simpson-Angus Extrapyramidal Side-Effects Scale (SAS)
2. Schizophrenia Cognition Rating Scale (SCoRS)
3. Brief Psychiatric Rating Scale (BPRS)
4. Clinical Global Impression (CGI) scale

Overall trial start date

15/01/2019

Overall trial end date

15/08/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Diagnosis of schizophrenia, according to ICD-10 criteria
2. Treatment-resistant schizophrenia, according to Modified Kane Criteria.
3. Right-handed
4. Normotensive
5. Aged 18 to 59 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. Neurological disorders with a history of epilepsy, organ damage, and any neurological procedure
2. Pacemakers or other implanted metal devices
3. Received ECT ≤6 months before enrolment
4. Substance use disorders, except nicotine and caffeine

Recruitment start date

15/05/2019

Recruitment end date

15/05/2020

Locations

Countries of recruitment

India

Trial participating centre

Shri Guru Ram Rai Institute
Patel Nagar
Dehradun
248001
India

Sponsor information

Organisation

Shri Guru Ram Rai Institute

Sponsor details

Patel Nagar
Dehradun
248001
India
+91 9582774305
dr.preetichauhan29@gmail.com

Sponsor type

University/education

Website

Organisation

Shri Mehent Indiresh Hospital

Sponsor details

Department of Psychiatry
Patel Nagar
Dehradun
248001
India
+91 (0135) 2522200, 6672400
sgrr.psychiatry@gmail.com

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Shri Guru Ram Rai University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in an international journal.

IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

20/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/06/2020: Trial’s existence confirmed by the Shri Guru Ram Rai Institute.