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.

Disorders of Consciousness  following Acquired Brain Injury  is one of the most severe forms of disability causing substantial economic, social and emotional burden. These patients by the nature of their impairment, reside in sensory-deprived environments. During the inpatient rehabilitation program, they undergo a conventional/ standard coma stimulation program using multimodal sensory stimuli by trained occupational therapists to assess and improve consciousness. However, the therapy is not tailored to individual patients. For patients at home or hospitals where a structured rehab program is not available, such stimulation is not possible the only way will be to wait and watch for spontaneous recovery which may be delayed.

PCASD is a device that has been recently indigenously designed for coma stimulation by for giving different kinds of sensory stimuli using sounds, lights, vibration, pictures, videos and odorants which were familiar and known to the patient. These stimuli are personalized in that they are selected for stimulation in discussion with the family regarding the premorbid likes and interests of the patient. Moreover the relatives of the patient can be trained to use the device. Early family-centered sensory and affective stimulation has been shown to be effective in improving the level of consciousness. This is thought to activate the neurological pathway and reinforce the circadian rhythm which might help to improve the responses to surroundings. The P-CASD device was developed by a technological institute with the device developers bearing the cost of the device and logistics.

In this randomized controlled study, we aim to study the effectiveness of coma stimulation using an PCASD as compared to conventional coma stimulation without the device to improve arousal in patients with disorders of consciousness following acquired brain injury.

Patients with Disorders of consciousness who satisfy inclusion and exclusion criteria will be randomly allocated to PCASD group(Intervention group) or coma stimulation group without the device(Control group) after obtaining informed written consent from relatives. Coma stimulation will be given in both groups by trained occupational therapist either without the device or using PCASD according to the allocated group for half an hour every day , 5 days a week for 4 weeks. Level of consciousness will be measured using the CRS- R (Coma Recovery Scale, Revised) and WHIM score – Wessex Head Injury Measure. Disability status will be measured using Disability Rating Scale (DRS). The assessments will be done at baseline and then after 4 weeks of intervention by a separate occupational therapist who will be blinded to the intervention. Both groups will receive all other standard rehabilitation therapies and medications. For patients in the PCASD group, relatives will be trained to use the device under supervision of the therapist during the 4th week. Feedback from caregivers regarding usability of the device will be obtained using a questionnaire. A follow up assessment will be done telephonically using the Disability Rating Scale at 3 months.