| CTRI Number |
CTRI/2025/03/081884 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Post doctoral fellow study for newer type of rTMS currently being researched for unconsciousness.] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Applications of iTBS in disorder of consciousness in diffuse axonal injury |
|
Scientific Title of Study
|
Investigating the Effectiveness of Intermittent Theta Burst Stimulation over left Dorsolateral Prefrontal Cortex in Disorders of Consciousness in Patients of Diffuse Axonal Injury: A Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tabassum Rahman |
| Designation |
Post Doctoral Fellow in Neuropsychiatry |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences
Hombegowda Nagar, Hosur, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
8618741460 |
| Fax |
|
| Email |
trahman.tr95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Urvakhsh M Mehta |
| Designation |
Additional Professor in Psychiatry |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences
Hombegowda Nagar, Hosur, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
urvakhsh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tabassum Rahman |
| Designation |
Post Doctoral Fellow in Neuropsychiatry |
| Affiliation |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences
Hombegowda Nagar, Hosur, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
8618741460 |
| Fax |
|
| Email |
trahman.tr95@gmail.com |
|
|
Source of Monetary or Material Support
|
| NIBS funds (Non-invasive brain stimulation), Project section, Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Hombegowda Nagar, Hosur road, Bangalore, Karanataka, India, 560029 |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neuro Sciences |
| Address |
Department of Psychiatry, National Institute of Mental Health and Neuro Sciences, Hombegowda Nagar, Hosur road, Bangalore |
| 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 Vivek Benegal |
National Institute of Mental Health and Neuro Sciences, NIMHANS |
TMS lab under Dept of Psychiatry and patients from surgery general ward under Dept of Neurosurgery, Hombegowda Nagar, Hosur Road, Bangalore
Bangalore
KARNATAKA |
08026995250
vbenegal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committee (Behavioral Sciences Division) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intermittent theta burst stimulation |
A type of rTMS, given at 600 pulses at left DLPFC at 80% of RMT, given as daily sessions of 12 sittings over 2 weeks. Each session lasts about 3 minutes. We will assess whether it is safe to take patient for this treatment and whether they can tolerate it, secondary outcome is improvement in consciousness using CRS-R scale measured before the intervention, immediately post the intervention, at 1 months, 3 and 6 months. This will be given alongside routine care. |
| Comparator Agent |
Routine care |
It comprises of good nursing care, management of comorbidities as part of general ward management of diffuse axonal injury until recovery of consciousness is noted, or patient is ready for discharge to home based care. The duration of such care on average in the the hospital ward is close to 2-3 months, based on severity of illness and comorbid conditions. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
With diffuse axonal injury on MRI brain having disorders of consciousness diagnosed clinically by the neurosurgery team and by the Coma Recovery Scale-Revised
Diagnosis of diffuse axonal injury made within 6 months, and patients having at least 2 weeks of disorders of consciousness after stabilization of acute condition
Managed in the head injury ward
Hemodynamically stable medical condition
|
|
| ExclusionCriteria |
| Details |
History of epilepsy or unprovoked seizures.
Presence of metallic implants or pacemakers.
Pregnant women
History of substance dependance in the last 1 month.
Disorders of consciousness due to other causes
Skull defects due to craniotomy
Those requiring assistance of ventilator
Those requiring ICU care
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasibility, safety and tolerability of iTBS in patients of diffuse axonal injury with disorders of consciousness |
Baseline assessments for consciousness, at start, midway, end of sessions and at 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement of consciousness with this protocol in such patients |
Baseline assessments for consciousness, at start, midway, end of sessions and at 3 and 6 months |
|
|
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 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [trahman.tr95@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Title: "Investigating the Effectiveness of Intermittent Theta Burst Stimulation (iTBS) over Left Dorsolateral Prefrontal Cortex (DLPFC) in Disorders of Consciousness in Patients of Diffuse Axonal Injury: A Randomized Controlled Trial."
Submitted by: Dr. Tabassum Rahman, Post-Doctoral Fellow in Neuropsychiatry, Department of Psychiatry, NIMHANS, under the guidance of Dr. Urvakhsh M. Mehta, Additional Professor, Department of Psychiatry, as well as co-guides Dr. Vikas V, Dr. Jitender Saini and Dr. Dhritiman C. from departments of Neurosurgery, Neuro-radiology and Neuro-anaesthesia, NIMHANS
Purpose of this study: To evaluate the feasibility, safety, and efficacy of iTBS, a non-invasive neuromodulation technique, in improving consciousness levels in patients with disorders of consciousness (DoC) caused by diffuse axonal injury (DAI).
Primary Objectives: Assess feasibility, safety, and tolerability of iTBS in DoC patients. Secondary Objectives: Evaluate iTBS’s efficacy in improving consciousness, functionality, and quality of life.
Research Design: Type: Double-blinded, parallel-group, randomized controlled trial (RCT). Sample Size: 30 patients (15 per group). Duration: 6 months after ethical clearance. Groups: True iTBS vs. Sham stimulation. Blinding of participants and outcome assessors.
Intervention: iTBS targeting left DLPFC, administered in 12 sessions over two weeks. We plan to give 600 pulses at 40% RMT.
Inclusion Criteria: Patients aged 4-60 years with MRI-confirmed DAI and DoC (<6 months post-injury) and 2 weeks after acute stabilization Hemodynamically stable patients from the Neurosurgery Department’s general ward.
Exclusion Criteria: History of epilepsy or unprovoked seizures. Presence of metallic implants or pacemakers. Pregnant women History of substance dependance in the last 1 month. Disorders of consciousness due to other causes Skull defects due to craniotomy Those requiring assistance of ventilator Those requiring ICU care
Outcome Measures: Primary: Feasibility metrics, adverse event monitoring. Secondary: Changes in Glasgow Coma Scale (GCS) and Coma Recovery Scale-Revised (CRS-R) scores, cognitive and functional assessments. Baseline assessments, then repeated midway, end of sessions at 3 months and 6 months
Ethical and Safety Considerations: Consent: Obtained from Legally Authorized Representatives (LAR) due to participants’ impaired consciousness. Monitoring: Adverse events tracked via a Treatment-Emergent Adverse Effects Inventory.
Funding and Approvals: Supported by NIMHANS NIBS research funds. Awaiting final ethics committee and CTRI registration approvals.
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