| 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 |
|
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Primary Sponsor
|
| Name |
Christian Medical College Vellore |
| Address |
Christian Medical College, Vellore, Tamilnadu, India |
| 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 |
| 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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S098||Other specified injuries of head, |
|
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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.
|
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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. |
|
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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. |
|
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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
|
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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. |