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CTRI Number  CTRI/2025/10/096141 [Registered on: 16/10/2025] Trial Registered Prospectively
Last Modified On: 15/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of transcranial direct current stimulation Combined with Mental Practice in improving upper limb muscle Strength and Function in People with Spinal Cord injury. 
Scientific Title of Study   Effect of Transcranial Direct Current Stimulation augmented with Motor imagery on Upper Extremity Muscle Strength and Function in Spinal Cord Injury 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nada Zareen 
Designation  MPT Student 
Affiliation  Indian Spinal Injuries Centre- Institute of rehabilitation sciences 
Address  Indian Spinal Injuries Center—Institute of Rehabilitation Sciences, Rehab Department.

South
DELHI
110070
India 
Phone  8130635550  
Fax    
Email  20nadazareen@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Megha Nijhawan 
Designation  Associate Professor, ISIC-IRS 
Affiliation  Indian Spinal Injuries Centre- Institute of rehabilitation sciences 
Address  Sector C, Vasant Kunj, Opp Vasant Valley School, New Delhi, Delhi

South
DELHI
110070
India 
Phone  8802021752  
Fax    
Email  physiomegha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Megha Nijhawan 
Designation  Associate Professor, ISIC-IRS 
Affiliation  Indian Spinal Injuries Centre- Institute of rehabilitation sciences 
Address  Sector C, Vasant Kunj, Opp Vasant Valley School, New Delhi, Delhi

South
DELHI
110070
India 
Phone  8802021752  
Fax    
Email  physiomegha@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal injury center- institute of rehabilitation science, Opp Sec C Main Vasant Kunj Road, New Delhi,110070 Delhi, India 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Megha Nijhawan  ISIC- Institute of Rehabilitation Science  Rehabilitation Department, opp. Vasant Valley School, IAA colony, Sector C, Vasant Kunj, New Delhi, 110070
South
DELHI 		 8802021752

physiomegha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G825||Quadriplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Anodal transcranial direct current stimulation augmented with MI + conventional therapy   This study will evaluate the combine effect of tDCS and motor imagery along with standard physiotherapy in individuals with spinal cord injury. Participants will be randomly divided into two groups. Group A will receive anodal tDCS (active stimulation) with motor imagery and regular physiotherapy and group B will receive sham tDCS (inactive stimulation) with motor imagery and regular physiotherapy. Procedure: In each session, you will receive either anodal tDCS or sham tDCS. At the same time, you will practice a set of exercises in your mind (motor imagery). After the stimulation, you will attempt to perform these exercises physically. tDCS will be applied using small pads placed on your head by gently spreading the hair. Your hair will not be removed. A mild electrical current of 1.5 mA will be given. During the stimulation, you will mentally practice hand and arm movements, such as picking up a cup or holding a pen.  
Comparator Agent  Sham transcranial direct current augment with motor imagery + conventional therapy   A current is given for 30s at the onset of stimulation and then stopped  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Incomplete SCI and classified as B, C and D on the ASIA Impairment Scale
2. 3 months post injury
3. Level of injury – C4-C7
4. Traumatic and non traumatic SCI
5. Willing to participate
 
 
ExclusionCriteria 
Details  1. Any other pre-existing neurological problem, musculoskeletal condition, Psychiatric problem that may interfere with the treatment
2. Spasticity of grade three or more on the Modified Ashworth Scale
3. History of seizures or brain surgery
4. Metallic brain implant
5. Cardiac Pacemaker
6. Pregnancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Motor activity log scale- amount of use (MAL-AOU)  03 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
upper extremity motor scale (UEMS)  03 weeks 
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)   03 weeks 
Isometric Muscle strength (myometer)  03 weeks 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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/ Phase 3 
Date of First Enrollment (India)   29/10/2025 
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="0"
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  

1.     Title:  Effect of Transcranial Direct Current Stimulation augmented with Motor imagery on Upper Extremity Muscle Strength and Function in Spinal Cord Injury 

Presenter’s Name: NADA ZAREEN, MPT (MUSCULOSKELETAL)

Guide: DR. MEGHA NIJHAWAN (ASSOCIATE PROFESSOR, ISIC-IRS)

Co-guide: DR. CHITRA KATARIA (PRINCIPAL, ISIC-IRS)

                  DR. MEENA MAKHIJA (ASSOCIATE PROFESSOR, ISIC-IRS)

 

2.     Background:

 

Spinal cord injury (SCI) results from an insult inflicted upon the spinal cord that affects upper and lower limb  functions entirely or incompletely. Transcranial direct current stimulation (tDCS) has been proposed as a tool that helps enhance neural plasticity and also helps the brain reach a favorable state of excitability, accelerating motor learning and training effects.

Motor imagery (MI) -mentally rehearsing movements—activates motor-related brain regions (M1, SMA, parietal cortex) and it may facilitate motor recovery by promoting neural plasticity. While studies show MI improves motor function, it works best combined with other therapies such as tDCS.

Purpose of the trial is to find the combined effect of transcranial direct current stimulation along with motor imagery on upper limb muscle strength and function in spinal cord injury patients.


 

3.     OBJECTIVES

To evaluate the effect of transcranial direct current stimulation augmented with motor imagery on Motor Activity Log- Amount Of Use (MAL-AOU), Upper Extremity Motor Score (UEMS), Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) and Isometric Muscle strength (myometer) in individuals with spinal cord injury.

 

HYPOTHESIS

Null Hypothesis Ho-

•       There is no significant difference in the effect of transcranial direct current stimulation augmented with motor imagery and sham tDCS with Motor Imagery on Upper Extremity Motor Score, Graded Redefined Assessment of Strength, Sensibility and Prehension, Isometric Muscle strength (myometer) and Motor Activity Log- Amount of Use in individual with spinal cord injury.

Alternate Hypothesis H1-

•       There is a significant difference in the effect of transcranial direct current stimulation augmented with motor imagery and sham tDCS with Motor Imagery on Upper Extremity Motor Score, Graded Redefined Assessment of Strength, Sensibility and Prehension, Isometric Muscle strength (myometer) and Motor Activity Log- Amount of Use in individual with spinal cord injury.

 

4.     Material and Methods

 

a.      Study Design: Randomized control study

 

b.     Sample size and method:  A total of 20 participants (10 in each group). A prior sample size of 10 in each group is calculated from previous work by taking as the MAL AOU primary outcome with an effect size of 1.36, alpha = 0.05, power of test = 0.80. Total sample size = 20 (10 in each group).

 

 

c.      Enrolment period: 3 months post injury

 

d.     Total Study duration: Time duration will be about 5 to 6 months.

 

 

e.    Inclusion and exclusion criteria: Eligible individuals will be aged 18–65 years, diagnosed with incomplete SCI and classified as B, C and D on the ASIA Impairment Scale (C4–C7 level), 3 months post injury. Any other pre-existing neurological problem, musculoskeletal condition, Psychiatric problem that may interfere with the treatment, Spasticity of grade three or more on the Modified Ashworth Scale, History of seizures or brain surgery, Metallic brain implant, Cardiac Pacemaker, Pregnancy will be excluded.

 

f.      Study procedure: In each session you will be given tDCS and simultaneously you will practice a set of exercises mentally (Motor imagery) after that you have to physically perform the exercises.

 

g.     Assessment tools: Upper Extremity Motor Score, Graded Redefined Assessment of Strength, Sensibility and Prehension, Isometric Muscle strength (myometer) and Motor Activity Log- Amount of Use.

 

5.  Statistical Analysis Plan:

Data will be analysed using SPSS v21.0. Normality will be tested with the Shapiro-Wilk test. Paired t-test or Wilcoxon test will be used for within-group comparisons, and independent t-test or Mann–Whitney U test for between-group comparisons. P value is less than 0.05.

 
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