| 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
|
|
|
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
|
|
|
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. |