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CTRI Number  CTRI/2025/07/091273 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Neuro rehabilitation]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the use of a personalized device for improving arousal in patients with reduced consciousness following brain injury 
Scientific Title of Study   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. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raji Thomas 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Dept. of Physical Medicine and Rehabilitation Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9489224955  
Fax    
Email  rajithomas@cmcvellore.ac.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Raji Thomas 
Designation  Professor 
Affiliation  Christian Medical College, Vellore 
Address  Dept. of Physical Medicine and Rehabilitation Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9489224955  
Fax    
Email  rajithomas@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  Yarlagadda Prudvish 
Designation  Assistant Professor 
Affiliation  Christian Medical College, Vellore 
Address  Dept. of Physical Medicine and Rehabilitation Christian Medical College, Vellore

Vellore
TAMIL NADU
632002
India 
Phone  9441233262  
Fax    
Email  prudvish.yarlagadda@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Department of Physical Medicine and Rehabilitation, CMC Vellore, Tamil Nadu 632002, India 
 
Primary Sponsor  
Name  Christian Medical College , Vellore 
Address  Christian Medical College, Vellore Tamil Nadu, India- 632004. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raji Thomas  Christian Medical College , Vellore  Department of Physical Medicine and Rehabilitation, Rehabilitation Institute, Office Room No 301,
Vellore
TAMIL NADU 
9489224955

rajithomas@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board ethic commitee, CMC, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S062||Diffuse traumatic brain injury,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Coma stimulation program  The control group undergoes conventional standard coma stimulation for 30 minutes a day for 5 sessions per week for 4 weeks. Stimulation will be done using standard visual, olfactory, tactile, gustatory and auditory stimuli by the therapist in a quiet environment when the patient is awake and non agitated. The same coma stimulation therapy will be given to both groups- Interventional group will get coma stimulation with help of device and comparison group will get without the device. However modalities & principles for stimulation will be similar. Rest of the rehabilitation therapy and treatment will be similar for both groups. 
Intervention  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 regarding the various likes and dislikes of the patient, hobbies, vocational and avocational activities of the patient premorbidly. The intervention group will be given coma stimulation using the PCASD for 30 minutes per day session per day for 20 sessions, 5 sessions a week for 4 weeks in a quiet room by the assigned therapist. The information obtained from the detailed history will be used to design the stimuli that are delivered through the PCASD. Simulation of day and night will also be provided to simulate a circadian rhythm. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Coma Recovery Scale, Wessex Head Injury Matrix, Disability Rating Scale  CRS and WHIM at Baseline , after 20 sessions. DRS at Baseline, after 20 sessions and after 3 months of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
Feed back questionnaire to assess usability of device in Intervention group   at the end of 20 sessions 
 
Target Sample Size   Total Sample Size="18"
Sample Size from India="18" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   11/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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