Health Condition 1: S069- Unspecified intracranial injury
Conditions
Interventions
None listed
Sponsors
Dr Dhaval P Shukla
Eligibility
Inclusion criteria
Inclusion criteria: Individuals who have sustained severe traumatic Brain injury in the age group of 18-65 years, who at 10 days post injury have a Disability Rating Scale (DRS) Score of > 15 and an inability to follow commands consistently (for more than 48 hours consecutively) and engage in functional communication, as assessed by the score on the Coma Recovery Scaleâ??Revised (CRS-R). Patients with hydrocephalus will be enrolled after VP shunt placement, and patients on psychoactive medication enrolled after discontinuation of those medications if possible.
Exclusion criteria
Exclusion criteria: Pre-existing CNS disorder/ disability prior to trauma, Medical instability, Significant medical co-morbidities that will influence trajectory of recovery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The DRS and CRS-R Scores will be analysed to plot the progress in state of consciousness over approximately 6 weeks from the time of injury and at subsequent follow up visits at 3, 6 and 12 months post trauma. Timepoint: 6 weeks from the time of injury and at subsequent follow up visits at 3, 6 and 12 months post trauma. | — |
Secondary
| Measure | Time frame |
|---|---|
| Demographic, clinical and radiological parameters at baseline as well as subsequent assessments will be analysed to understand how these parameters affect the trajectory of recovery in such patients.Timepoint: 6 weeks from the time of injury and at subsequent follow up visits at 3, 6 and 12 months post trauma. | — |
Countries
India
Contacts
Public ContactDr Kevin Jude Sudevan
National Institute of Mental Health and Neurosciences (NIMHANS)
Outcome results
None listed