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Applications of iTBS in disorder of consciousness in diffuse axonal injury

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 - Nil

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/081884
Enrollment
30
Registered
2025-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: S062- Diffuse traumatic brain injury

Interventions

Intervention1: 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 mi

Sponsors

National Institute of Mental Health and Neuro Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Feasibility, safety and tolerability of iTBS in patients of diffuse axonal injury with disorders of consciousnessTimepoint: Baseline assessments for consciousness, at start, midway, end of sessions and at 3 and 6 months

Secondary

MeasureTime frame
Improvement of consciousness with this protocol in such patientsTimepoint: Baseline assessments for consciousness, at start, midway, end of sessions and at 3 and 6 months

Countries

India

Contacts

Public ContactTabassum Rahman

National Institute of Mental Health and Neuro Sciences

urvakhsh@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026