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Effect of transcranial direct current stimulation and multimodal early onset on traumatic brain injury participants

Efficacy of Transcranial Direct Current Stimulation Versus Multimodal Early Onset Stimulation on Consciousness, Coma Recovery, Cognition, and Length of Hospital Stay in Severe Traumatic Brain Injury Participants: A Randomized Controlled Trial. - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083476
Enrollment
40
Registered
2025-03-26
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 Health Condition 2: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Intervention1: Transcranial Direct Current Stimulation: The patient will be positioned in supine lying, with tCDS will be applied first to the left dorsolateral prefrontal cortex (lDLPFC)or to the bil

Sponsors

Ravi Nair Physiotherapy College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male or Female Participants in coma following TBI with GCS scores less than or equal to 8 Coma caused by severe TBI in age group 18-65 years Coma that lasted more than one week Condition and vital signs were stable Family members voluntarily agreed to let the participant participate in the study and signed an informed consent

Exclusion criteria

Exclusion criteria: 1. Individuals with recurrent brain injuries are not eligible for participation. 2. The presence of metallic implants or electronic devices in the brain or skull will disqualify participants. 3. Participants with trauma at the scalp will be excluded from the study. 4. Individuals younger than 18 years or older than 65 years will not be included. 5. Pregnant or lactating women are excluded from participation. 6. A history of epilepsy or seizure disorders will lead to exclusion. 7. Participants with pre-existing neurological or psychiatric disorders are not eligible. 8. Individuals with unstable hemodynamic conditions will be excluded. 9. Participants with severe organ failure (e.g., heart, liver, or kidney) are not eligible for the study. 10. Those with active infections requiring intravenous antibiotics will be excluded. 11. Chronic use of medications affecting consciousness or cognition will disqualify participants. 12. Individuals unable to undergo MRI or CT imaging will not be included. 13. Participants with fractures or injuries preventing safe positioning for stimulation are excluded. 14. Burns, wounds, or scalp lesions at the stimulation sites will lead to exclusion. 15. Individuals with penetrating head injuries are not eligible for participation. 16. Prior neuromodulation therapies will disqualify participants from the study. 17. Participants with intracranial hematomas or midline shift greater than 5 mm will be excluded. 18. Documented brain death will lead to exclusion from participation.

Design outcomes

Primary

MeasureTime frame
Glasgow Outcome Scale (GOS), Glasgow Coma Scale (GCS) ICU Mobility Scale, Coma Recovery Scale-Revised (CRS-R) Rancho Los Amigos ScaleTimepoint: Baseline, 2 weeks and 4 weeks

Secondary

MeasureTime frame
Western Neuro Sensory Stimulation ProfileTimepoint: Baseline, 2 weeks and 4 weeks

Countries

India

Contacts

Public ContactDrYukta Ghugal

Ravi Nair Physiotherapy College

raghuneuro@yahoo.com8126506769

Outcome results

None listed

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