| CTRI Number |
CTRI/2019/11/022009 [Registered on: 14/11/2019] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Non iNvasive Brain Stimulation] |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A clinical interventional study to compare the efficacy of two combined non invasive brain stimulation as motor enhancement therapy for upper extremity in brain attack due to blocked blood vessel cases of more than six months. |
|
Scientific Title of Study
|
A randomized controlled trial to compare the efficacy of coupled transcranial stimulation with decoupled transcranial stimulation and sham stimulation as motor enhancement therapy for upper extremity in chronic ischemic stroke cases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil K NarayanGuide |
| Designation |
Professor (Senior scale) |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of Neurology
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132297280 |
| Fax |
|
| Email |
sknarayan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jeshma Jayan |
| Designation |
PhD Student |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of neurology
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132297447 |
| Fax |
|
| Email |
jeshmajayan07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jeshma Jayan |
| Designation |
PhD Student |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of neurology
Pondicherry
PONDICHERRY
605006
India |
| Phone |
04132297447 |
| Fax |
|
| Email |
jeshmajayan07@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Dhanvantri nagar, Puducherry,605006 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Jeshma Jayan |
JIPMER |
Neurobionics lab, IPD division of Department of neurology,Super speciality block,JIPMER
Pondicherry
PONDICHERRY |
9159731260
jeshmajayan07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institute Ethics committee (IEC)–human studies. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Real tDCS and Real rTMS |
Coupled non invasive brain stimulation (20 minutes of tDCS followed by 20 minutes of rTMS/day for ten sessions) |
| Comparator Agent |
Sham tDCS and Sham rTMS, Sham tDCS and real rTMS, real tDCS and sham rTMS |
Decoupled non invasive brain stimulation((20 minutes of tDCS followed by 20 minutes of rTMS/day for ten sessions)) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Age between 18year and 70year
b) Cases diagnosed as stroke by MRI/CT scan as non-recurrent chronic MCA ischemic stroke
c) Cases after six months of post stroke
d) Normal as per Montreal Cognitive Assessment
e) Brunnstrom 3-5 stages of recovery
R |
|
| ExclusionCriteria |
| Details |
a) Any contraindications for rTMS/tDCS intervention.
b) Any other associated neuropsychiatric disorder
c) Underwent any prior non-invasive brain stimulation
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fugl-Meyer Assessment - Upper extremity |
Baseline, After 10 sessions of treatment, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Modified Ashworth Scale(MMAS), Somatosensory evoked potential(SSEP), Single Photon Emission Computed Tomography(SPECT), Modified Rankin Scale(mRS) and Stroke Specific Quality of Life Scale (SS-QOL) |
Baseline, After 10 sessions of treatment, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/11/2019 |
| Date of Study Completion (India) |
03/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
03/03/2026 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
https://doi.org/10.1016/j.jstrokecerebrovasdis.2023.107418 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In search of finding out a new paradigm to maximize the therapeutic effect, the study aims to couple the neurostimulatory repetitive transcranial magnetic stimulation after priming the brain using neuromodulatory transcranial direct current stimulation to enhance the upper extremity motor function in chronic ischemic post stroke cases. |