A study of the effect of transcranial magnetic stimulation on cerebellum vermis in treatment-resistant schizophrenia
| ISRCTN | ISRCTN49569866 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49569866 |
| Secondary identifying numbers | SGRR/IEC/1/19 |
- Submission date
- 28/05/2020
- Registration date
- 08/06/2020
- Last edited
- 04/03/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Department of Psychiatry
Shri Guru Ram Rai Institute of Medical and Health Sciences
Dehradun
248001
India
 ORCID ID |
0000-0002-1512-9152 |
|---|---|
| Phone | +91 9582774305 |
| dr.preetichauhan29@gmail.com |
Study information
| Study design | Single-centre, double-blind, placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Efficacy of adjunctive intermittent theta-burst transcranial magnetic stimulation for treatment-resistant schizophrenia: a randomized placebo-controlled study |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/01/2019 |
| Completion date | 15/08/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 36 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/05/2019 |
| Date of final enrolment | 15/05/2020 |
Locations
Countries of recruitment
- India
Study participating centre
Dehradun
248001
India
Sponsor information
University/education
Patel Nagar
Dehradun
248001
India
| Phone | +91 9582774305 |
|---|---|
| dr.preetichauhan29@gmail.com |
Hospital/treatment centre
Department of Psychiatry
Patel Nagar
Dehradun
248001
India
| Phone | +91 (0135) 2522200, 6672400 |
|---|---|
| sgrr.psychiatry@gmail.com |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 20/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an international journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 22/09/2020 | 04/03/2022 | Yes | No |
Editorial Notes
04/03/2022: Publication reference and total final enrolment added.
04/06/2020: Trial’s existence confirmed by the Shri Guru Ram Rai Institute.
