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To evaluate the use of a personalized device for improving arousal in patients with reduced consciousness following brain injury

Effectiveness of Personalized Coma Arousal Stimulating Device (PCASD) to improve consciousness in patients with disorders of consciousness due to Acquired Brain Injury - A pilot study. - nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/07/091273
Enrollment
18
Registered
2025-07-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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: Personalized Coma stimulation with PCASD device: Basline assessment will be done using CRS R, WHIM and DRS scores. A detailed history will be taken from the relative of the patient reg

Sponsors

Christian Medical College , Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients with Disorders of consciousness (Coma,Vegetative state, Minimally conscious state) i.e.RLA stages 1-3 following acquired brain injury and as per CRS Revised score 2.Patients admitted in Rehabilitation institute for rehabilitation 3. 18-80 years of age 4.Duration of injury- 3 months to within 1 year 5.Medically and neurologically stable

Exclusion criteria

Exclusion criteria: 1.History of seizures in last 1 month 2.DoC more than 1 year 3. Patients with medical complications such as hyponatremia, sepsis, venous thromboembolism or similar complications requiring additional management and patients with neurological complications such as persistent seizures, posttraumatic hydrocephalus, meningitis and delayed intracranial hematoma.

Design outcomes

Primary

MeasureTime frame
Coma Recovery Scale, Wessex Head Injury Matrix, Disability Rating ScaleTimepoint: CRS and WHIM at Baseline , after 20 sessions. DRS at Baseline, after 20 sessions and after 3 months of intervention

Secondary

MeasureTime frame
Feed back questionnaire to assess usability of device in Intervention groupTimepoint: at the end of 20 sessions

Countries

India

Contacts

Public ContactYarlagadda Prudvish

Christian Medical College, Vellore

rajithomas@cmcvellore.ac.in9489224955

Outcome results

None listed

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