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CTRI Number  CTRI/2023/11/060074 [Registered on: 21/11/2023] Trial Registered Prospectively
Last Modified On: 17/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Caregiver-mediated Multi Modal Sensory Stimulation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Sensory Stimulation by caregivers to improve consciousness in persons with severe brain injury 
Scientific Title of Study   Caregiver-mediated Vellore intense Multimodal Sensory Stimulation (Vi-MuSt) for improving the level of consciousness in patients with severe brain injury: A Single-blind, Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jones Jeromedanypraveenraj  
Designation  Assistant Professor 
Affiliation  Christian Medical College, Vellore 
Address  Occupational Therapy, Rehabilitation Institute, Department of PMR, Christian Medical College, Vellore

Vellore
TAMIL NADU
632002
India 
Phone  9894832099  
Fax    
Email  jeromedany18@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Jones Jeromedanypraveenraj  
Designation  Assistant Professor 
Affiliation  Christian Medical College, Vellore 
Address  Occupational Therapy, Rehabilitation Institute, Department of PMR, Christian Medical College, Vellore


TAMIL NADU
632002
India 
Phone  9894832099  
Fax    
Email  jeromedany18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Jones Jeromedanypraveenraj  
Designation  Assistant Professor 
Affiliation  Christian Medical College, Vellore 
Address  Occupational Therapy, Rehabilitation Institute, Department of PMR, Christian Medical College, Vellore


TAMIL NADU
632002
India 
Phone  9894832099  
Fax    
Email  jeromedany18@gmail.com  
 
Source of Monetary or Material Support  
Fluid Research Funding, Christian Medical College, Vellore, Tamilnadu, India 
 
Primary Sponsor  
Name  Christian Medical College Vellore 
Address  Christian Medical College, Vellore, Tamilnadu, India 
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 
JEROME DANY PRAVEEN RAJ  Christian Medical College, Vellore  Christian Medical College, Vellore,Tamilnadu, India
Vellore
TAMIL NADU 
09894832099

jeromedany18@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S098||Other specified injuries of head,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Caregiver-mediated Vellore intense Multimodal Sensory Stimulation (Vi-MuSt)  The patients in the intervention group will receive a 4-week, residential, interdisciplinary rehabilitation program along with a structured, caregiver-mediated Vellore intense multi modal sensory stimulation (Vi-MuSt) program. The caregivers of persons with brain injury in the Vi-MuSt group will be educated and trained by the Occupational, Physical and Speech Therapists in the first week of admission on how to carry out the stimulation program during the therapy and at their rooms. The therapists will also use therapeutic techniques for Coma Stimulation on the persons with brain injury during their therapy sessions. Vi-MuSt program includes Auditory Stimulation, Visual Stimulation, Tactile Stimulation, Olfactory Stimulation, Gustatory Stimulation, Kinesthetic Stimulation and Proprioceptive stimulation. The Vi-MuSt stimulation program will be carried out for 4 weeks during the stay at Rehabilitation Institute. Each stimulation session can last from 20 to 30 minutes for five times a day between 6 am to 9 pm and 6 days a week. The type of stimulation for each session can be isolated or in combination of all. The caregivers will be given a Response sheet to mark the patients’ responses for each stimulus every day for 4 weeks. Pre-assessment will be done in the first week after the allocation to the group and Post assessment after 4 weeks following the pre-assessment in both the groups. Since we already follow a session system in Rehabilitation Institute, both Intervention and control group patients will be allotted to different sessions to avoid contamination of information.  
Comparator Agent  Usual care group  The usual care group will receive a 4-week, residential, interdisciplinary rehabilitation program for patients with disorders of consciousness after Acquired brain injury. The salient features of the intervention provided at the rehabilitation center are the following: Caregivers Education and training, Interventions to prevent secondary complications, Team meetings, Group therapy and Multi-modal sensory stimulation program. The Multi-modal sensory stimulation is mostly Therapist-mediated or Therapist-driven in the respective therapy areas. It will be an unstructured sensory stimulation provided by therapists which includes Auditory, Visual, Tactile, Olfactory, gustatory, Kinesthetic and Proprioceptive stimulation.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with brain injury who are in Coma, Unresponsive Wakefulness Syndrome (UWS) and Minimally Conscious State (MCS), RLA stage I to III (No response, generalized response and localized response). 
 
ExclusionCriteria 
Details  Patients with complications such as recurrent seizures, unstable vital signs will be excluded. 
 
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 
JFK Coma recovery scale- Revised (CRS-R), Wessex Head Injury Matrix (WHIM)  Pre-assessment will be done in the first week after the allocation to the group and Post assessment after 4 weeks following the pre-assessment in both the groups.  
 
Secondary Outcome  
Outcome  TimePoints 
Disability Rating Scale (DRS)  Pre-assessment will be done in the first week after the allocation to the group and Post assessment after 4 weeks following the pre-assessment in both the groups.  
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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 
Date of First Enrollment (India)   01/12/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Multi-modal sensory stimulation is considered as a treatment method to reduce the risk of sensory deprivation and facilitate brain recovery responses in patients with a decreased level of consciousness following brain injury. Multi-modal sensory stimulation programs in the early stages after brain injury can be very useful for the recovery process. Involving the family members in sensory stimulation, besides providing them with the opportunity to get engaged in patient care, accelerates the improvement of patients’ level of consciousness, cognitive status, and recovery. Caregiver-mediated Multi-modal sensory stimulation will be beneficial for the patients with severe brain injury because they spend the most of their time in a day with patients’.

The caregivers of persons with brain injury in the Vi-MuSt group will be educated and trained by the Occupational, Physical and Speech Therapists on how to carry out the stimulation program during the therapy and at their rooms. Each stimulation session can last from 20 to 30 minutes for five times a day between 6 am to 9 pm and 6 days a week. The usual care group will receive regular intervention provided by the therapists during the therapy hours along with the involvement of caregivers. The primary outcome measures used will be JFK Coma recovery scale- Revised (CRS-R) and Wessex Head Injury Matrix (WHIM) and Secondary Outcome measure used will be Disability Rating Scale (DRS). Pre-assessment will be done in the first week after the allocation to the group and Post assessment after 4 weeks following the pre-assessment in both the groups.


 
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