| CTRI Number |
CTRI/2026/04/107276 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
28/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Placebo Controlled Trial |
|
Public Title of Study
|
Immediate effects of brain stimulation (tDCS) on individuals suffering from shoulder pain after a stroke. |
|
Scientific Title of Study
|
Immediate Effects of transcranial Direct Current Stimulation (tDCS) on post-stroke shoulder pain. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Ananya Rakesh Sharma |
| Designation |
Principal Investigator |
| Affiliation |
Department of Physiotherapy, St. Johns Medical College Hospital |
| Address |
Department of Physiotherapy, Ground floor, 42/85 Room number, St. Johns Medical College Sarjapur Marathahalli Road beside bank of Baroda John Nagar Koramangala Bengaluru Karnataka India
Bangalore
KARNATAKA
560034
India |
| Phone |
6363542916 |
| Fax |
|
| Email |
ananya.sharma@stjohns.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr GRK Sarma |
| Designation |
Co Investigator |
| Affiliation |
Department of Neurology, St. Johns Medical College Hospital |
| Address |
Department of Neurology, 3rd floor, Rear wing, St. Johns Medical College Sarjapur Marathahalli Road beside bank of Baroda John Nagar Koramangala Bengaluru Karnataka India
Bangalore
KARNATAKA
560034
India |
| Phone |
919886732622 |
| Fax |
|
| Email |
grk_sarma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GRK Sarma |
| Designation |
Co Investigator |
| Affiliation |
Department of Neurology, St. Johns Medical College Hospital |
| Address |
Department of Neurology, 3rd floor, Rear wing, St. Johns Medical College Sarjapur Marathahalli Road beside bank of Baroda John Nagar Koramangala Bengaluru Karnataka India
Bangalore
KARNATAKA
560034
India |
| Phone |
919886732622 |
| Fax |
|
| Email |
grk_sarma@yahoo.com |
|
|
Source of Monetary or Material Support
|
| St. Johns Medical College Hospital, Sarjapur Road, opposite the Bank of Baroda, in John Nagar, Koramangala, Bengaluru, Karnataka 560034 |
|
|
Primary Sponsor
|
| Name |
Self Funded |
| Address |
St. Johns Medical College Hospital, Sarjapur Road, opposite the Bank of Baroda, in John Nagar, Koramangala, Bengaluru, Karnataka 560034 |
| Type of Sponsor |
Private medical college |
|
|
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 GRK Sarma |
St. Johns Medical College Hospital |
Rear wing, Dept. of Neurology, Third floor, St. Johns Medical College Hospital, Sarjapur Road, Koramangala, Bengaluru, Karnataka 560034
Bangalore
KARNATAKA |
9886732622
grk_sarma@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee St Johns National Academy of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I63||Cerebral infarction, (2) ICD-10 Condition: I62||Other and unspecified nontraumaticintracranial hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham: Transcranial Direct Current Stimulation |
Sham tDCS will be applied with anode over the ipsilesional primary motor region (M1) and cathode over the contralesional primary motor region (cM1) for 20 min. The device will ramp up the current to 2mA for 15seconds to create the sensation of the start of the session. After which, the device will automatically shut off. They will also receive conventional physiotherapy, which includes relevant precautions, sling prescription and Transcutaneous Electrical Stimulation (TENS) application along with tDCS.
TENS will be given for 20 minutes, 80Hz, 200µS pulse width. |
| Intervention |
Transcranial Direct Current Stimulation |
tDCS will be applied with anode over the ipsilesional primary motor region (M1) and cathode over the contralesional primary motor region (cM1) for 20 min. The device will ramp up the current to 2mA with precise increments of 0.1mA. They will also receive conventional physiotherapy, which includes relevant precautions, sling prescription and Transcutaneous Electrical Stimulation (TENS) application along with tDCS.
TENS will be given for 20 minutes, 80Hz, 200µS pulse width. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who had suffered ischemic or hemorrhagic stroke presenting after 7 days with MRI changes as evidence.
An individual with post-stroke shoulder pain.
Patients who consent to participate. |
|
| ExclusionCriteria |
| Details |
History of epilepsy or diagnosed with any other neurological disorder
Recurrent CVA
Presence of cardiac pacemaker |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| McGill Pain Questionnaire |
Baseline, Immediately post treatment, and 2 hours post-treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale |
Baseline, Immediately post treatment, and 2 hours post-treatment. |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
10/04/2026 |
| 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="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
|
Shoulder pain is a common post-stroke symptom, with a prevalence ranging from 30% to 65% among stroke survivors. It can significantly limit participation in rehabilitation, reduce the use of the affected upper limb, and impair performance in activities of daily living, thereby negatively affecting functional recovery. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that delivers low-intensity electrical current through scalp electrodes to modulate cortical excitability. In recent years, tDCS has shown promising results in reducing post-stroke pain. The primary motor cortex (M1) is the most commonly targeted stimulation site, and research suggests that stimulation of this region may influence pain perception by modulating cortical networks involved in pain processing. Previous research has explored the effects of repeated tDCS sessions on outcomes such as motor recovery and chronic pain following stroke. However, there is limited evidence regarding the immediate analgesic effects of a single session of tDCS on post-stroke shoulder pain. Understanding whether tDCS can produce an immediate reduction in pain may be clinically beneficial, as it could reduce discomfort and facilitate greater participation in upper limb rehabilitation. Therefore, this study aims to assess whether tDCS has an immediate effect on reducing post-stroke shoulder pain when combined with usual care. A 2 mA direct current will be applied using tDCS with the anode placed over the ipsilesional primary motor cortex (M1) and the cathode over the contralesional primary motor cortex (cM1) for 20 minutes. Participants will be divided into two groups: an active tDCS group and a sham tDCS group. Both groups will receive conventional physiotherapy, which includes relevant precautions, sling prescription, and Transcutaneous Electrical Nerve Stimulation (TENS). TENS will be applied for 20 minutes at a frequency of 80 Hz with a pulse width of 200 µs. Pain intensity will be assessed using the Visual Analog Scale (VAS) and the McGill Pain Questionnaire. Pain measurements will be recorded at baseline, immediately after the intervention, and 2 hours post-treatment to evaluate the immediate analgesic effect of tDCS. |