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