| CTRI Number |
CTRI/2025/01/079487 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cognitive Rehabilitation] |
| Study Design |
Other |
|
Public Title of Study
|
Role of Neuroimaging in Understanding the cognitive functions and enhancing recovery through cognitive rehabilitation in traumatic brain injury patients |
|
Scientific Title of Study
|
The Role of Neuroimaging assisted Functional and structural connectomics in cognitive rehabilitation following traumatic brain injury in relation to Neurological outcomes, Lobar functioning and Emotional Recognition- A prospective longitudinal 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 |
Madhumathi P C |
| Designation |
PhD Scholar |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sahaya Sriramachandra Rehabilitation Centre,
1st floor, annex building,
Sri Ramachandra Hospital,
No 1, Ramachandra nagar,
Chennai
Chennai
TAMIL NADU
600118
India |
| Phone |
|
| Fax |
|
| Email |
madhumathipcphd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Visvanathan K |
| Designation |
Professor and HOD |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
A2, 2nd floor,
Medical Centre,
Sri Ramachandra Hospital,
No 1, Ramachandra nagar
Chennai
Chennai
TAMIL NADU
600118
India |
| Phone |
9710082924 |
| Fax |
|
| Email |
visvanathan.k@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Visvanathan K |
| Designation |
Professor and HOD |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
A2, 2nd floor,
Medical Centre,
Sri Ramachandra Hospital,
No 1, Ramachandra nagar
Chennai
TAMIL NADU
600118
India |
| Phone |
9710082924 |
| Fax |
|
| Email |
visvanathan.k@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research
No 1, Ramachandra nagar,
Chennai, Tamil Nadu, India
600118 |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No 1, ramachandra nagar
Chennai,Tamil Nadu, India
600118 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Madhumathi P C |
Sri Ramachandra Institute of Higher education and research |
Department of Neurosurgery,
Medical Centre,
sri Ramachandra Hospital,
No 1, Ramachandra nagar
Chennai
Chennai
TAMIL NADU |
9710082924
madhumathipcphd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Cognitive rehabilitation |
The cognitive rehabilitation will be delivered either online or offline. For online rehabilitation, participants will use an app called Cognifit, which focuses on enhancing cognition through stimulating games. For offline rehabilitation, specifically for patients with severe brain injuries, therapies will be provided to address and retrain cognitive deficits. The retraining process will last between 4 and 6 weeks, depending on the individual’s needs. |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
age- 18-65 years both male and female
patients who had sustained a brain injury with the GCS score of 4-15
|
|
| ExclusionCriteria |
| Details |
Other pre-existing neurological disorders or prior head injury
Patients with Impaired vision
Haemodynamic instability that persists for more than 7 days after injury
Clinical evidence of brainstem dysfunction within 7 days of admission
conditions contraindicative of MRI such as implants
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Correlation between neuropsychological assessment scores and neuroimaging results
2. Relationship between structural and functional connectivity
3. Improvements in cognitive functioning post cognitive rehabilitation
4. Evidence of neuroplasticity observed through changes in brain connectivity |
Measured at Baseline (T1), 3 months (T2), and 6 months (T3) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Resting state network activations correlated with specific cognitive domains
2. Recovery patterns based on TBI severity
3. Cognitive domains specific improvements will be observed
4. Overall cognitive & brain recovery across severity & time points |
Measured at Baseline (T1), 3 months(T2), 6 months(T3) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2025 |
| 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="6"
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
|
The study aims to explore the relationship between neuroimaging assisted brain connectivity patterns and cognitive recovery in Traumatic Brain Injury (TBI) patients, with a focus on cognitive rehabilitation outcomes. By utilizing advanced structural and functional neuroimaging techniques, the research observes the correlation of neuropsychological scores with the neuroimaging results over three time points. The study examines the recovery cognitive functions such as attention, memory, visuospatial cognition, visual perception and emotional recognition. The study aims to explore how cognitive rehabilitation improves brain plasticity, promotes recovery and improvement in TBI patients. |