| CTRI Number |
CTRI/2026/02/103004 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
How Brain Activation Methods and Mental Exercises Help Improve Brain Function and Physical Movement in People with Head Injury |
|
Scientific Title of Study
|
Efficacy of Neuromodulation and Cognitive Rehabilitation Therapy in Enhancing Neuroplasticity in Patients with Traumatic Brain Injury. |
| Trial Acronym |
ENCORE-TBI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A YASHUDAS |
| Designation |
PhD Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Room No. 210, PhD Scholar Room,
Level 2, Block 4,
Department of Physiotherapy,
School of Allied Medical Science,
Lovely Professional University,
Jalandhar Delhi G.T. Road,
Phagwara, Punjab (India)
Jalandhar
PUNJAB
144411
India |
| Phone |
09559216499 |
| Fax |
|
| Email |
dr.anthoni@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ramesh Chandra Patra |
| Designation |
Professor |
| Affiliation |
Lovely Professional University |
| Address |
Cabin 3, Room No. 213,
Level 2, Block 4,
Department of Physiotherapy,
School of Allied Medical Science,
Lovely Professional University,
Jalandhar Delhi G.T. Road,
Phagwara, Punjab (India)
Jalandhar
PUNJAB
144411
India |
| Phone |
09653174563 |
| Fax |
|
| Email |
ramesh.19500@lpu.co.in |
|
Details of Contact Person
Public Query
|
| Name |
A YASHUDAS |
| Designation |
PhD Scholar |
| Affiliation |
Lovely Professional University |
| Address |
Room No. 210, PhD Scholar Room,
Level 2, Block 4,
Department of Physiotherapy,
School of Allied Medical Science,
Lovely Professional University,
Jalandhar Delhi G.T. Road,
Phagwara, Punjab (India)
Jalandhar
PUNJAB
144411
India |
| Phone |
9559216499 |
| Fax |
|
| Email |
dr.anthoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,
Lovely Professional University,
Jalandhar Delhi G.T. Road,
Phagwara, Punjab (India) - 144411 |
|
|
Primary Sponsor
|
| Name |
A YASHUDAS |
| Address |
Lovely Professional University,
Jalandhar Delhi G.T. Road,
Phagwara, Punjab (India) - 144411 |
| Type of Sponsor |
Other [Self-Funding] |
|
|
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 |
| A Yashudas |
Lovely Professional University |
Room No. 105,
Level 1, Block 3,
Department of Physiotherapy,
School of Allied Medical Science,
Lovely Professional University,
Jalandhar Delhi G.T. Road,
Phagwara, Punjab (India)
Jalandhar
PUNJAB |
9559216499
dr.anthoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC-LPU), Lovely Professional University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S062||Diffuse traumatic brain injury, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Active tDCS + Cognitive Rehabilitation Therapy. |
Active tDCS:-
Active tDCS (Soterix Medical 1x1 CT, New York, USA) applied at 2 mA for 30 minutes per session. Electrodes (25 cm² rubber, saline-saturated) will be placed with the anode over the left dorsolateral pre- frontal cortex (F3 location of the 10–20 EEG system) and the cathode over the occipital region (1.5 cm anterior to Cz)
Cognitive Rehabilitation Therapy:-
Cognitive-Motor Training (Cogni-Motor): Exercises used in this intervention are integrated and target both the cognitive and physical domains at the same time. While completing activities like walking sequences, balancing on unstable surfaces (like balance boards), or negotiating obstacle courses, participants will also be working on cognitive difficulties including verbal fluency exercises, memory recall exercises, and arithmetic calculations. By mimicking the demands of multitasking in real life, the objective is to improve motor control, executive function, and dual-task processing.
Sensorimotor Therapy: The goal of this treatment is to improve proprioception, balance, and motor
coordination. To enhance neuromuscular integration and functional stability, especially in those with TBI-related motor deficits, interventions include guided balance training, postural control exercises, and movement planning activities.
|
| Comparator Agent |
Group B: Placebo tDCS + Cognitive Rehabilitation Therapy |
Placebo tDCS:-
Placebo tDCS will be administered using identical electrode placement and device settings; current will be ramped up over 15 seconds then switched off to simulate sensation without stimulation
Placebo tDCS (Soterix Medical 1x1 CT, New York, USA) applied at 2 mA for 30 minutes per session. Electrodes (25 cm² rubber, saline-saturated) will be placed with the anode over the left dorsolateral pre- frontal cortex (F3 location of the 10–20 EEG system) and the cathode over the occipital region (1.5 cm anterior to Cz)
Cognitive Rehabilitation Therapy:-
Cognitive-Motor Training (Cogni-Motor): Exercises used in this intervention are integrated and target both the cognitive and physical domains at the same time. While completing activities like walking sequences, balancing on unstable surfaces (like balance boards), or negotiating obstacle courses, participants will also be working on cognitive difficulties including verbal fluency exercises, memory recall exercises, and arithmetic calculations. By mimicking the demands of multitasking in real life, the objective is to improve motor control, executive function, and dual-task processing.
Sensorimotor Therapy: The goal of this treatment is to improve proprioception, balance, and motor
coordination. To enhance neuromuscular integration and functional stability, especially in those with TBI-related motor deficits, interventions include guided balance training, postural control exercises, and movement planning activities.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
Adult aged 18 to 50 years.
Diagnosis of Mild to moderate traumatic Brain Injury (TBI) confirmed by clinical assessment and imaging.
Minimum Post Injury duration of 3 months.
Presence of Neurocognitive deficits as per the MoCA Scale
Able to Provide Informed consent. |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
Sever TBI Glasgow Coma Scale less than 8.
Pre existing neurological of psychiatric disorders.
Implanted medical devices any pacemaker or cochlear implants.
Scalp lesions or skin condition at electrode placement sites. Pregnancy or breastfeeding.
Patient with history of epilepsy or seizure.
Progressive neurodegenerative diseases,
Major psychiatric disorders such as schizophrenia, bipolar disorder, major depression are excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Electroencephalography (EEG)
2. Montreal Cognitive Assessment (MoCA)
3. Fugl-Meyer Assessment (FMA) |
1. 4 times
2. 4 times
3. 4 times |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Functional Independence Measure (FIM)- (Functional Independence)
2. Quality of Life Short form-36 (QoL SF-36)- (Quality of Life ) |
1. 4 times
2. 4 times |
|
|
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)
|
02/03/2026 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ramesh.19500@lpu.co.in].
- For how long will this data be available start date provided 01-04-2028 and end date provided 31-03-2033?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This Randomized parallel group, placebo-controlled trial evaluates the efficacy of neuromodulation combined with cognitive rehabilitation therapy in enhancing neuroplasticity among patients with traumatic brain injury. Group A (n = 20) receives active transcranial direct current stimulation (tDCS) with cognitive rehabilitation therapy, while Group B (n = 20) receive placebo tDCS with cognitive rehabilitation therapy. Both groups undergo interventions thrice weekly over six months, total 72 sessions of 90 minutes with inclusive resting time. Four time periods will be used to evaluate all outcome measure: two baseline assessments (Pre-intervention) one month apart, post-intervention (6 month), and a three-month follow-up. Primary Outcomes are EEG (neuroplasticity), MoCA (Cognitive function), FMA (Motor recovery) and Secondary Outcomes are FIM (Functional Independence), QoL SF-36 (Quality of Life). |