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CTRI Number  CTRI/2026/02/103047 [Registered on: 04/02/2026] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Transcranial direct current stimulation (HD-tDCS)]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Assessment of the safety and effectiveness of tDCS as an add-on therapy for managing upper limb spasticity after stroke: a randomized controlled trial 
Scientific Title of Study   Safety and efficacy of adjunctive transcranial direct current stimulation (t DCS) in the management of post-stroke upper limb spasticity: a randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ranjeet Kumar 
Designation  MSc Neurotechnology Student 
Affiliation  Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Neurology, JIPMER, JIPMER Campus, Gorimedu
Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  8210754221  
Fax    
Email  ranjeetkumar0688@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ranjeet Kumar 
Designation  MSc Neurotechnology Student 
Affiliation  Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Neurology, JIPMER, JIPMER Campus, Gorimedu
Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  8210754221  
Fax    
Email  ranjeetkumar0688@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ranjeet Kumar 
Designation  MSc Neurotechnology Student 
Affiliation  Department of Neurology, Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Neurology, JIPMER, JIPMER Campus, Gorimedu
Puducherry
Pondicherry
PONDICHERRY
605006
India 
Phone  8210754221  
Fax    
Email  ranjeetkumar0688@gmail.com  
 
Source of Monetary or Material Support  
Intramural Grant, JIPMER, Pondicherry, India, 605006 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) 
Address  JIPMER Campus, Gorimedu, Puducherry 605006, India 
Type of Sponsor  Research institution and hospital 
 
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 Saranya B Gomathy   Jawaharlal Institute of Postgraduate Medical Education and Research  Room No. 5242, Department of Neurology, 2nd floor, Superspeciality block, JIPMER
Pondicherry
PONDICHERRY 		 8129606651

gomathysubramoniam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee – Interventional Studies, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I693||Sequelae of cerebral infarction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Sham tDCS  Sham (placebo) tDCS applied over the affected motor cortex, combined with standard rehabilitation therapy 
Intervention  Transcranial direct current stimulation (tDCS)  tDCS applied over the affected motor cortex, combined with standard rehabilitation therapy for 10 days (weekly 5 sessions for 2 weeks) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  First ever ischemic or hemorrhagic stroke confirmed clinically and radiologically

Stroke onset greater than or equal to 3 months to 2 years before enrolment

MAS score greater than or equal to 2 in affected upper limb

Stable medication and rehabilitation regimen with no major changes in spasticity drugs in past 4 weeks 
 
ExclusionCriteria 
Details  History of epilepsy, CNS tumors, or neurodegenerative disorders

Pacemaker or metallic implants

Recurrent stroke

Severe cognitive impairment or psychiatric disorders interfering with participation

Pre-existing severe musculoskeletal conditions in affected limb

Uncontrolled hypertension or hemodynamic instability

Active skin lesions at electrode sites

Pregnancy 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of adjunctive tDCS in reducing post-stroke upper limb spasticity compared to sham tDCS alone by measuring the changes in the Modified Ashworth Scale (MAS) score over 4 weeks.  Baseline and 4 weeks post-intervention 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the safety and tolerability of tDCS in post stroke spasticity at 4 weeks  Baseline and 4 weeks post-intervention 
To compare changes in motor function using the Fugl-Meyer Assessment upper extremity (FMA-UE) scale be-tween the 2 groups at 4 weeks  Baseline and 4 weeks post-intervention 
To compare the quality of life improvements using the Stroke Impact Scale between the 2 groups at 4 weeks.  Baseline and 4 weeks post-intervention 
To compare functional improvement between the 2 groups, including manual dexterity and daily activity performance, using the Jebsen-Taylor Hand Function Test at 4 weeks  Baseline and 4 weeks post-intervention 
To analyse the sustained effects of tDCS on spasticity at follow-up (3 months post-intervention)  Baseline and 4 weeks post-intervention 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 3 
Date of First Enrollment (India)   24/02/2026 
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="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 prospective, randomized controlled trial designed to evaluate the safety and efficacy of adjunctive  transcranial direct current stimulation (tDCS) in adult patients with post-stroke upper limb spasticity. The trial will compare active tDCS combined with standard rehabilitation therapy to sham tDCS combined with standard therapy over a four-week period. The primary hypothesis is that tDCS will significantly reduce upper limb spasticity as measured by the Modified Ashworth Scale compared to sham stimulation. Secondary outcomes include improvements in motor function, functional performance, quality of life, and monitoring of safety outcomes. Participants will be followed at four weeks and three months post-intervention to evaluate both immediate and sustained effects. The study aims to provide evidence for tDCS as a safe and effective non-invasive adjunct therapy to enhance upper limb recovery in patients with chronic stroke.

 
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