| CTRI Number |
CTRI/2024/03/063549 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
24/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Giving Magnetic therapy a type of Brain Stimulation to Help People with Schizophrenia with Their Thinking and speech.
|
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Scientific Title of Study
|
Modulating the Left - Anterior Temporal Lobe with Intermittent theta Burst Stimulation to target Language and Cognitive dysfunctions in patients with schizophrenia: An Open label Pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kiran Basawaraj Bagali |
| Designation |
Clinical Research Training Fellow and Senior Resident, Department of Psychiatry |
| Affiliation |
NIMHANS |
| Address |
Department of Psychiatry, NIMHANS, Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026972049 |
| Fax |
|
| Email |
bagalikiran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Urvakhsh Mehta |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS (National Institute of Mental Health and Neurosciences) |
| Address |
Department of Psychiatry, NIMHANS(National Institute of Mental Health and Neurosciences), Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995805 |
| Fax |
|
| Email |
urvakhsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Basawaraj Bagali |
| Designation |
Clinical Research Training Fellow and Senior Resident, Department of Psychiatry |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS), Hosur Road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
08026972049 |
| Fax |
|
| Email |
bagalikiran@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2023 - Research Fund Award, granted to Dr Kiran Basawaraj Bagali by Schizophrenia International Research Society (SIRS), an International body that aims to bring together researchers and clinicians in schizophrenia and related disorders. |
|
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Primary Sponsor
|
| Name |
Dr Pratima Murthy |
| Address |
Director Office, NIMHANS Campus, Hosur Road, Bengaluru |
| Type of Sponsor |
Other [The Director of the Institute ( NIMHANS(National Institute of Mental Health and Neurosciences)] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Kiran Basawaraj Bagali |
NIMHANS, Hospital |
Room No. 2, Interventional Psychiatry lab, 4th Floor, Yoga Centre, Department of
Psychiatry, NIMHANS campus,
Hosur Road,
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
08026972049
bagalikiran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committee - Behavioural Sciences |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intermittent theta burst stimulation a type of transcranial magnetic stimulation |
Intermittent theta burst stimulation (iTBS) a type of transcranial magnetic stimulation over left anterior temporal lobe. Two sessions of iTBS, one hour apart, will be provided with 1800 pulses in each session every day for five days. |
| Comparator Agent |
No comparator agent used as this is a single arm study |
no comparator agents used in this study |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with schizophrenia with capacity to consent.
2. Age range: 18 – 45 years
3. Patients with schizophrenia exhibiting cognitive deficits, defined as BACS scores (any domain) falling 1 or more standard deviations below the mean and standard deviation derived from a local healthy population cohort.
4. Right handed individuals assessed by Edinburgh Handedness scale.
5. Having moderate level of symptoms as measured by a score of 4 or more on Global rating on any domains in SAPS or SANS scale.
6. No contraindication for MRI and TMS (as assessed by TASS checklist)
7. No risk of harm to self or harm to others
8. No active substance use in the last 3 months (apart from nicotine).
|
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| ExclusionCriteria |
| Details |
1. Features suggestive of risk of harm to self (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)
2. Unstable medical condition
3. History of uncontrolled seizures
4. Co morbid medical or neurological disorder that can affect structure of the brain.
5. Pregnancy or postpartum state
6. Comorbid substance abuse or dependence
7. Significant neurologic disorder
8. Any contraindication for MRI & TMS
9. Left/mixed Handedness
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Verbal fluency Test scores. |
Time point 1 (T1)- Baseline
Time point 2 (T2)- End of intervention of the study i.e End of 10th session (5DAYS) or termination of the trial for any predefined reasons) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Scale for the Assessment of Positive Symptom (SAPS)
2. Scale for the Assessment of Negative Symptom (SANS)
3. Brief Psychiatric Rating Scale (BPRS).
4. Clinical Global Impressions (CGI) Scale
5. Brief Assessment of Cognition in Schizophrenia (BACS)
6. Social and Occupational Functioning Assessment Scale (SOFAS)
7. NLP (Natural Language Processing) metrics derived from recorded speech interview.
8. Brain magnetic imaging measures
(structural image, task based functional images, resting-state functional images, diffusion tensor images, glutamate levels at left anterior temporal cortex from MR spectroscopy)
9. TMS- Electroencephalography measures at Baseline.
|
Time point 1 (T1)- Baseline
Time point 2 (T2)- End of intervention of the study i.e End of 10th session (5DAYS) or termination of the trial for
any predefined reasons) |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
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Brief Summary
|
This open label single arm study will look at targeting anterior temporal lobe using iTBS (intermittent theta burst) as potential method of alleviating language and cognitive dysfunctions seen in patients with schizophrenia. In addition it will also look at understanding the neural correlates of language and cognitive dysfunctions that occur in this disorder. A target sample of 30 participants will recruited who will receive treatment of 5 days with MRI, Language and cognitive tests will be done before and after treatment.
Aim(s) Evidence suggests that inhibiting the left ATL using cTBS leads to a deceleration in
semantic processing speed, accompanied by structural and functional connectivity alterations at
the stimulation site and areas functionally linked to the left ATL (Jung and Lambon Ralph, 2021).
Moreover, this decline in semantic cognition due to cTBS over the left ATL is influenced by the
baseline excitatory-inhibitory balance of the region, contributing to inter-individual variability in
responses. This highlights the importance of examining the biological factors in this region
alongside behavioural measures to comprehend individual-level response differences.
In light of these findings, which establish a connection between left ATL modulation and alterations
in semantic cognition in healthy individuals, coupled with the observed language and cognitive
deficits in patients with schizophrenia that are associated with the ATL, these collective insights
form the basis for our study hypothesis. Our study aims to investigate
A. Primary
a. To examine the effects of intermittent Theta Burst Stimulation (iTBS) over the left ATL (targeted
via their T1 image) on verbal fluency in participants with a diagnosis of schizophrenia.
 Hypothesis: iTBS will enhance verbal fluency as measured via categorical-fluency,
phonemic-fluency, and picture-based word production tests
B. Secondary
a. To examine the effects of iTBS over left ATL on global measures of cognition, NLP measures of
speech and language, symptoms, and interpersonal functioning.
 Hypothesis: iTBS will enhance cognition, and functioning and alleviate symptoms.
b. To examine the functional connectivity changes of the left ATL following iTBS during task and
rest states
 Hypothesis: Patients with poorer performance on Category Fluency task (more errors/decreased
number of words) will have decreased activation of left ATL regions. And will have aberrant
connectivity to frontal executive networks.
c. At baseline to examine TMS-EEG measures over Left ATL (TMS Evoked Potentials) as moderators
of verbal fluency change with iTBS.
 Hypothesis: The TEP’s measured at baseline will inform about the state dependent dynamics of the
ATL which may explain the variance in response to neuromodulation (iTBS).
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