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 Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Feasibility, safety and tolerability of iTBS in patients of diffuse axonal injury with disorders of consciousness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 4.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
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.
Outcomes
Primary Outcomes
Feasibility, safety and tolerability of iTBS in patients of diffuse axonal injury with disorders of consciousness
Time Frame: Baseline assessments for consciousness, at start, midway, end of sessions and at 3 and 6 months
Secondary Outcomes
- 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)
Investigators
Tabassum Rahman
National Institute of Mental Health and Neuro Sciences