| CTRI Number |
CTRI/2024/09/073372 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Virtual Cognitive Retraining for Traumatic Brain Injury |
|
Scientific Title of Study
|
Effect of Virtual Cognitive Retraining Program on Neuropsychological Functioning & Hemodynamic
Response in Traumatic Brain Injury: A 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 |
Rahul Joshi |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology
NIMHANS
Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9838634878 |
| Fax |
|
| Email |
rahul.nimhanscp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Keshav Kumar J |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology
NIMHANS
Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9900032852 |
| Fax |
|
| Email |
keshavjkapp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Joshi |
| Designation |
PhD Scholar |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Clinical Psychology
NIMHANS
Hosur Road
Bangalore
KARNATAKA
560029
India |
| Phone |
9838634878 |
| Fax |
|
| Email |
rahul.nimhanscp@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, 560029 |
| University Grants Commission (UGC), Bahadur Shah Zafar Marg,
New Delhi - 110002 |
|
|
Primary Sponsor
|
| Name |
University Grants Commission |
| Address |
University Grants Commission (UGC), Bahadur Shah Zafar Marg,
New Delhi - 110002 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhaval P Shukla |
National Institute of Mental Health and Neuroscience |
Room no 110, Neurosurgery OPD, Department of Neurosurgery, National Institute of Mental Health and Neuroscience
Bangalore
KARNATAKA |
9898073843
dhavalshukla@nimhans.ac.in |
| Dr Keshav Kumar J |
National Institute of Mental Health and Neuroscience |
Room no 1, Neuro Psychology Unit, Department of Clinical Psychology, Ashiwini Block, National Institute of Mental Health and Neuroscience, Hosur Road
Bangalore
KARNATAKA |
9900032852
keshavjkapp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of SDS TRC and RGICD SDS TRC And RGICD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S06||Intracranial injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Treatment as usual |
Treatment as usual will include the clinical services that are availed by patients on routine |
| Intervention |
Virtual Cognitive Retraining Program |
An established package of Cognitive Retraining Program developed for TBI (Kumar, 1999), and briefer versions for depression and schizophrenia (Kumar et al., 2013; Banerjee, 2020) with necessary modifications to suit the TBI patients is proposed. The intervention will be called Virtual Cognitive Retraining Program - vCRP. The program will be delivered virtually through online video-conferencing. The virtual program comprise of tasks for retraining of attention (focused and sustained), cognitive control, response inhibition, cognitive updating, reasoning, processing speed, encoding and fluency. These retraining tasks will be in hierarchical level of difficulty. Participant will be required to have at least 80% performance on earlier levels to move to the next level of difficulty. The participant will be required to work on multiple domains in every session. The brain training program aims to enhance executive functions by presenting target stimuli across different cognitive domains at increasing difficulty levels. Individuals are encouraged to move up the difficulty levels within a given task, with mastery of higher levels known to stimulate targeted cognitive abilities.
The proposed intervention program consists of 18 online sessions, spread over a period of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
a.Clinically stable patients with a diagnosis of Traumatic Brain Injury.
b.Normal/corrected vision and hearing.
c.Handedness Right.
d.Minimum time elapsed since head injury: Three months.
e.Total score of 9-15 on the Glasgow Coma Scale at the time of injury.
f.Presence of neuropsychological deficit.
g.Access to a personal computer or smartphone.
h.Familiarity with video calling and mobile phone applications.
i.Ability to read and write, Hindi, English or Kannada. |
|
| ExclusionCriteria |
| Details |
a.Severe sensorimotor, personality changes and language deficits making them not amenable to testing.
b.Decompressive Craniotomy without bone replacement.
c.History of substance dependence (except tobacco).
d.History of mental retardation.
e.History of psychiatric, neurological, or neurosurgical conditions.
f.History of a chronic debilitating medical condition.
g.Undergoing psychological intervention, in the past 6 months.
h.No access to a personal computer or mobile phone. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Processing speed
Working memory
Oxy-Hemoglobin (HbO)
Deoxy-hemoglobin (HbR) |
Baseline, 1 week Post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
WHO Quality of life (brief)
Rivermead Head Injury Follow Up Questionnaire
Rivermead Post Concussion Symptom Questionnaire
NIMHANS Cognitive Complain Scale |
Baseline, & 1 week Post intervention |
|
|
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)
|
20/09/2024 |
| 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="4"
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
|
Traumatic brain injuries (TBI) pose a significant public health challenge in India, with over 6.5 million reported cases in 2019. Men, particularly those aged 16-35, are most affected, primarily due to road traffic accidents. TBIs lead to disabilities that impact sustained attention, planning, initiation, perseverance, and task completion. They also cause difficulties in response inhibition and impair social and occupational functioning.
Cognitive retraining is a proven strategy for neuropsychological rehabilitation, enhancing cognitive functions across various neurological and neuropsychiatric disorders. Traditional cognitive retraining programs typically last 5-6 weeks in hospital settings. However, there is a growing need for virtual programs to increase accessibility and reduce costs. Despite advancements, research on cognitive retraining’s impact, particularly neuroplastic changes assessed through brain imaging, remains limited. Only 11 studies from 1985 to 2016 have used neuroimaging to evaluate neuroplastic changes following cognitive retraining in TBI patients. Functional Near-Infrared Spectroscopy (fNIRS) is a promising, non-invasive brain imaging technique. Its cost-effectiveness and mobility make it ideal for assessing resting state and task-based hemodynamic responses (HbO-HbR), especially in individuals with head injuries.
This research aims to evaluate the impact of a Virtual Cognitive Retraining Program, delivered via Google Meet, on the neuropsychological functioning of mild to moderate TBI patients with a Glasgow Coma Scale (GCS) score between 9 and 15. The study will also investigate hemodynamic responses using fNIRS. This randomized controlled trial (RCT) includes one treatment arm and one active control arm, each with 20 mild/moderate TBI patients. An equivalent number of age-matched healthy participants will be recruited for comparative analysis, focusing on neuropsychological functioning and hemodynamic responses. |