| CTRI Number |
CTRI/2024/12/078146 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Trial to Study the Effectiveness of Cognitive Rehabilitation Program in Improving Cognitive and Day to Day Functioning of Mild and Complicated Mild Traumatic Brain Injury Patients (Tentative) |
|
Scientific Title of Study
|
Efficacy of Cognitive Retraining and Compensatory Based Rehabilitation Program in Enhancing Cognitive and Day to Day Functioning of Mild and Complicated Mild Traumatic Brain Injury Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saishree |
| Designation |
PhD Research Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Psychology, Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7011709243 |
| Fax |
|
| Email |
saishree0777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jay Kumar Ranjan |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Psychology,
Banaras Hindu University
(Dr Jay Kumar Ranjan is currently on lien, working in the Department of Psychological Sciences,
Central University of South Bihar,
NH120, Gaya Panchanpur Road,
Gaya, Bihar, 824236)
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9304153083 |
| Fax |
|
| Email |
jaykumarranjan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hari Shanker Asthana |
| Designation |
Senior Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Psychology,
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8765508636 |
| Fax |
|
| Email |
drhsasthana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Junior Research Fellowship (JRF) from the University Grants Commission (UGC), Bahadur Shah Zafar Marg, New Delhi, Pincode - 110002, India |
|
|
Primary Sponsor
|
| Name |
University Grants Commission (UGC) |
| Address |
Bahadur Shah Zafar Marg,
New Delhi
Pincode - 110002 |
| Type of Sponsor |
Government funding agency |
|
|
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 Nityanand Pandey |
Sir Sunderlal Hospital |
Room no. 17
Neurosurgery, OPD
Sir Sunderlal Hospital
Banaras Hindu University, Varanasi,
Pincode - 221005
India
Varanasi
UTTAR PRADESH |
9555303666
nityanand_pandey@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-S09||Injuries to the head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Retraining and Compensatory Based Strategies |
Cognitive rehabilitation contains two components: cognitive retraining and compensatory based strategies.
The American Psychological Association (APA) Dictionary of Psychology defines Cognitive Rehabilitation as a "specific rehabilitation intervention designed to address problems in mental processing that are associated with chronic illness, brain injury, or trauma, such as stroke. Cognitive rehabilitation may include relearning specific mental abilities, strengthening unaffected abilities, or substituting new abilities to compensate for lost ones."
Cognitive retraining involves performing repetitive tasks that may cause patterns of atypical brain activation in the brain, such as, the temporal and frontal lobes (Perdue et al., 2022). Repetitive activation in brain areas like right medial prefrontal cortex, and right ventral anterior cingulate cortex (Hara et al., 2021), have improved both attention and memory. Thus, development in the structural changes may convey restoration of psychological functions; thereby, generalizing to daily tasks.
Compensatory strategies are used as an additional measure to be used along with cognitive retraining (Jones, Benge & Scullin, 2021). It aims to alleviate psychosocial disability by targeting functioning directly using aids and strategies, thereby minimizing the impact of cognitive impairment (Weakley, Weakley & Edgecombe, 2019). Sone examples include use of diary, calendar and alarms.
The intervention will include administering of homework assignments as well.
The program will be tailored according to each patient and will span up to two and a half months, containing 33 sessions of 2 hours each. Post assessment will take place after the program is completed at 5 to 6 month of the injury after which the follow up will take place at the 7th to 8th month of the injury. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria: MTBI
1. Brain damage due to external trauma
2. GCS score of 13-15 at the time of arrival
3. Age range from 18 years to 45 years
4. Educated 8th class and above
5. Ability to comprehend English or Hindi
6. Time post injury 1- 3 months
7. Cooperation from the patient and caregiver
Inclusion criteria: Complicated MTBI
1. Brain damage due to external trauma
2. GCS score of 13-15 at the time of arrival
3. Neuroimaging shows intracranial abnormalities
4. Age range from 18 years to 45 years
5. Educated 8th class and above
6. Ability to comprehend English or Hindi
7. Time post injury up to 1- 3 months
8. Cooperation from the patient and caregiver |
|
| ExclusionCriteria |
| Details |
Exclusion criteria: MTBI
1. Neuroimaging shows intracranial abnormalities
2. Severe deficits in motor, visual or hearing abilities
3. Past history of mental illness, i.e. Substance use disorder, Schizophrenia, Anxiety, Depression, and other psychiatric disorders
4. Past history of neurodevelopmental, neurodegenerative or any other neurological disease, i.e. Intellectual disability, Epilepsy, Early onset dementia, Stroke, Brain tumour, Parkinsons disease, Alzheimer disease and Multiple sclerosis etc.
Exclusion criteria: Complicated MTBI
1. Severe deficits in motor, visual or hearing abilities
2. Past history of mental illness, i.e. Substance use disorder, Schizophrenia, Anxiety, Depression, and other psychiatric disorders
3. Past history of neurodevelopmental, neurodegenerative or any other neurological disease, i.e. Intellectual disability, Epilepsy, Early onset dementia, Stroke, Brain tumour, Parkinsons disease, Alzheimer disease and Multiple sclerosis etc. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. PGI Battery of Brain Dysfunction for assessing Brain Dysfunction
2. Cognitive symptoms checklist for assessing Activities of Daily Living |
1. Pre-test
2. Post-test
3. Follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demographic variables (age, gender, occupation, marital status, education) |
1. Pre-test
2. Post-test
3. Follow up |
| Clinical variables (time post-injury, duration of post-traumatic amnesia (PTA), duration of loss of consciousness (LOC)) |
1. Pre-test
2. Post-test
3. Follow up |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
23/12/2024 |
| 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="1"
Months="6"
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
|
This study is a repeated measures design with three time points pre-test, post-test and follow up. The study is investigating the efficacy of cognitive retraining and compensatory strategies program in enhancing cognitive functions and activities of daily living in mild and complicated mild traumatic brain injury patients. Patients sustaining injury prior to 3 months will be recruited and assessed. Each patient is recruited upon consideration of the inclusion and exclusion criteria of the study. Patient consent will be taken after which the cognitive rehabilitation program will be provided to the patient. The program will be tailored according to each patient and will span up to two and a half months, containing 33 sessions of 2 hours each. Post assessment will take place after the program is completed at 5 to 6 month of the injury after which the follow up will take place at the 7th to 8th month of the injury. |