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Clinical Trials/CTRI/2025/10/096141
CTRI/2025/10/096141Not yet recruitingPhase 2/3

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

Not provided1 site in 1 country20 target enrollmentStarted: October 29, 2025Last updated:

Trial Snapshot

Phase
Phase 2/3
Status
Not yet recruiting
Enrollment
20
Locations
1
Primary Endpoint
Motor activity log scale- amount of use (MAL-AOU)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Incomplete SCI and classified as B, C and D on the ASIA Impairment Scale
  • 3 months post injury
  • Level of injury – C4-C7
  • Traumatic and non traumatic SCI
  • Willing to participate.

Exclusion Criteria

  • 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 6.

Outcomes

Primary Outcomes

Motor activity log scale- amount of use (MAL-AOU)

Time Frame: 03 weeks

Secondary Outcomes

  • upper extremity motor scale (UEMS)(03 weeks)
  • Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)(03 weeks)
  • Isometric Muscle strength (myometer)(03 weeks)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Nada Zareen

Indian Spinal Injuries Centre- Institute of rehabilitation sciences

Study Sites (1)

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