| CTRI Number |
CTRI/2023/10/058415 [Registered on: 06/10/2023] Trial Registered Prospectively |
| Last Modified On: |
04/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Transcranial Alternating Current Stimulation] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of Adjunctive Cerebellar Transcranial
Alternating Current Stimulation in Negative
Symptoms of Schizophrenia |
|
Scientific Title of Study
|
Efficacy of Adjunctive Cerebellar Theta Transcranial
Alternating Current Stimulation in Negative
Symptoms of Schizophrenia: A Randomized Sham
Controlled Proton Magnetic Resonance
Spectroscopy (H1-MRS) Based Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiranmai K |
| Designation |
Junior Resident |
| Affiliation |
Central Institute of Psychiatry |
| Address |
Room No: 108, New PG Resident Hostel (Al Razi), Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand.
Ranchi
JHARKHAND
834006
India |
| Phone |
9100392718 |
| Fax |
|
| Email |
kiranmaikypu27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh S |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
KS Mani Centre for Cognitive Neurosciences, Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand.
Ranchi
JHARKHAND
834006
India |
| Phone |
9771702403 |
| Fax |
|
| Email |
umesh.yes@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh S |
| Designation |
Associate Professor of Psychiatry |
| Affiliation |
Central Institute of Psychiatry |
| Address |
KS Mani Centre for Cognitive Neurosciences, Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand.
Ranchi
JHARKHAND
834006
India |
| Phone |
9771702403 |
| Fax |
|
| Email |
umesh.yes@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand. |
|
|
Primary Sponsor
|
| Name |
Central Institute of Psychiatry |
| Address |
Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Kiranmai K |
Central Institute of Psychiatry |
KS Mani Centre for Cognitive Neurosciences and Girindra Shekhar Bose Centre for Neuroimaging and Radiological Sciences, Department of Psychiatry, Central Institute of Psychiatry, Kanke, Ranchi, Jharkhand
Ranchi
JHARKHAND |
9100392718
kiranmaikypu27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, CIP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Theta Transcranial Alternating Current Stimulation (tACS), Active. |
Theta frequency tACS will be administered using a standard equipment using stringent safety measures. Cerebellum will be stimulated in the
midline. One electrode will be placed 2cm below inion (active) and the other on the right buccinator muscle (return) according to 10-20 system. 10 sessions of theta (5Hz) frequency tACS will be given over a period of 2 weeks (5 sessions/week) using standard equipment. 20 minutes
of sinusoidal tACS will be given at 5Hz frequency. |
| Comparator Agent |
Theta Transcranial Alternating Current Stimulation (tACS), Sham. |
2 mA current will be applied for 30 sec in the exact location as stated in active process giving
an initial sensation of tACS while minimizing stimulatory effects. 10 sessions of theta will be given over a period of 2 weeks (5 sessions/week). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosis of Schizophrenia using International Classification of Diseases-11th edition
(ICD-11) (WHO, 2019).
2. Patients giving written informed consent.
3. Right-handed patients.
4. Illness duration of equal to or more than 2 years.
5. The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) with negative
symptoms score of more than 15.
6. Scale for Assessment of Negative Symptoms (SANS) score more than 20.
7. Calgary Depression Scale for Schizophrenia (CDSS) score less than 7.
|
|
| 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. Patients having any metallic implants in the body.
4. Subjects who have received ECT in past 1 month.
|
|
|
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 Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cerebellar theta tACS results in a change in the negative symptoms at the end of 10 sessions. |
Improvement in the scores of PANSS, SANS, CGI at the end of 10 sessions(2 weeks) & 6 weeks as compared to baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the levels of GABA, Glutamate, Glutamine, NAA & NAAG in cerebellum using Proton MR Spectroscopy post theta tACS administration to cerebellum. |
Baseline, at the end of 10 theta tACS sessions(2 weeks). |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Schizophrenia is a complex, chronic mental health disorder characterized by an array of symptoms, including delusions, hallucinations, disorganized speech or behavior, and impaired cognitive ability. Negative symptoms continue to remain as one of the greater causes of morbidity in patients with schizophrenia leaving the patient non-functional and thereby increasing the caregiver burden further. The pharmacological managements have proven to be of little use in managing the negative symptoms manifesting the need for other interventions. Transcranial alternating current stimulation (tACS) uses bidirectional biphasic current that periodically fluctuates/alternate from positive to negative charges across the 2 electrodes. It is hypothesized that if sinusoidal current is applied externally, it can increase or decrease the power of endogenous oscillatory rhythms in the brain and can potentially rectify the abnormalities in brain oscillations. A study has shown that stimulation of cerebellum using theta tACS has resulted in the changes in theta activity in frontal cortex. Thus this technique can thus be used to bring about activation in frontal cortex which can probably help in alleviating the negative symptoms. Magnetic Resonance Spectroscopy can be used to measure the levels of various neuronal metabolites which can increase or decrease based on brain pathology. In neurodegenerative diseases, there is usually a decrease seen in the levels of various metabolites, owing to cell death happening. In psychiatric disorders like schizophrenia, there is an increased glutamate predicted which may cause excitotoxicity, leading to focal neuronal death in the affected regions. Thus, much later in the disease process, one would expect the pyramidal cells to die off, leading to decreased glutamate levels, decreased NAA and choline levels, and further decreased GABA levels as negative feedback inhibition is further decreased. To the best of our knowledge, there has been no study assessing the efficacy of adjunctive theta tACS in negative symptoms of schizophrenia and one evidencing the changes in metabolites of cerebellum in patients of negative symptoms of schizophrenia. |