| CTRI Number |
CTRI/2025/08/093025 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Supporting Arm and Hand Recovery After Stroke with Non-Invasive Therapy |
|
Scientific Title of Study
|
Effects of Repetitive-Transcranial Magnetic Stimulation on Neurophysiological and Clinical Outcomes in Upper Limb Post-stroke recovery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kaviraja Udupa |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences(NIMHANS)) |
| Address |
Department of Neurophysiology,
NIMHANS,
Bengaluru 560029,
Karanataka
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995914 |
| Fax |
|
| Email |
kaviudupa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kaviraja Udupa |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences(NIMHANS)) |
| Address |
Department of Neurophysiology,
NIMHANS,
Bengaluru 560029,
Karanataka
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995914 |
| Fax |
|
| Email |
kaviudupa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaviraja Udupa |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences(NIMHANS)) |
| Address |
Department of Neurophysiology,
NIMHANS,
Bengaluru 560029,
Karanataka
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995914 |
| Fax |
|
| Email |
kaviudupa@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health and Neuro Sciences, Government of India, Hosur Road, Bengaluru-560029, Karnataka, INDIA |
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
NIMHANS, Bengaluru 560029, Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kaviraja Udupa |
National Institute of Mental Health and Neuro Sciences |
Room no : 1010, Special OPD Block, CNN Laboratory, Department of Neurophysiology, NIMHANS, Bengaluru India, 560029 Banglore, Karanataka
Bangalore
KARNATAKA |
08026995914
kaviudupa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Not Applicable |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G938||Other specified disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Repetitive Transcranial Magnetic stimulation (rTMS) |
Stroke patients with 7 days of Repetitive Transcranial Magnetic stimulation (rTMS) intervention. The treatment protocol involves administering low-frequency repetitive transcranial magnetic stimulation (rTMS) as an inhibitory stimulus to attenuate hyperexcitability by inducing long-term depression (LTD)-like effects in cortical neurons. The butterfly-shaped TMS coil is positioned over the primary motor cortex (M1) region, corresponding to the C3 or C4(depending on the stroke hemisphere) location in the international 10-20 EEG system, on the hemisphere contralateral to the lesioned side. The low-frequency stimulation (1 Hz) of 1200 pulses with insterstimulus interval of 1 second is applied to the contralesional M1 (unaffected hemisphere) for 20 min in stroke patients, The intervention is delivered over seven consecutive days, comprising 12 sessions in total, one session on days 1 and 7, and two sessions per day from days 2 to 6. |
| Comparator Agent |
Standard of Care |
Stroke patients in this group will receive pharmacotherapy and physiotherapy during the subacute phase, without any repetitive transcranial magnetic stimulation (rTMS) intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient with ischemic stroke (based on TOAST criteria)
1. with upper limb motor impairment– hemiplegia/monoplegia (based on MRC scale)
2. in early sub-acute phase of stroke
3. age range 18-60 years old
4. anterior circulation stroke
5. with moderate and severe disability modified Rankin Scale (mRS) score ranges from 2 to 5
6. with moderate and severe stroke severity National Institutes of Health Stroke Scale (NIHSS) 5 to 42
|
|
| ExclusionCriteria |
| Details |
1. Patients who
i. are unable to cooperate due to global aphasia
ii. are having cerebral venous thrombosis
iii. are in ICU ventilators, cardio-respiratory distress
iv. are having hemorrhagic stroke
v. are having Primary Psychiatric disorders
2. Patients have contraindications to TMS, such as those who
i. had a past history or family history of seizures and epilepsy
ii. have epileptic discharge in EEG
iii. Had a H/O LOC due to seizures and brain tumors
iv. have metal implants on the head and neck such as surgical clips, dental implants, cochlear implants, stents in the head and neck
v. have undergone decompressive craniotomy
vi. having a cardiac pacemaker or cardiac stent
vii. are pregnant
viii. had a H/O cardiovascular disease such as Ischemic Heart Disease with low ejection fraction and cardiac failure
ix. have a history of brain tumor
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of rTMS in post-stroke patients in terms of Clinical outcome measures using BI- Barthel Index, MRS-Modified Rankin Scale, NIHSS- National Institute of Health Stroke Scale, WMFT- Wolf Motor Function Test
|
Baseline- Preintervention Day -1
Postintervention Day-7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of rTMS in post-stroke patients in terms of Neurophysiological measures using Single-pulse and paired-pulse TMS measures, Heart Rate Variability Measures (HRV) and Electroencephalographic measures (EEG)
|
Baseline- Preintervention Day -1
Postintervention Day-7 |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
08/09/2025 |
| 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="3"
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
|
In stroke majority of patients experience upper limb motor impairments, with a mere 5-20% regaining the full functionality. Upper limb dysfunction ultimately impairs a stroke patient’s quality of life and independence . This limitation can profoundly impact their daily lives, hindering activities like food, clothing, and personal cleanliness and ultimately compromising their independence. The balance between the brain hemispheres were disrupted by stroke leading to motor impairment . Researchers have investigated the use of rTMS to restore the upper limb function and also to improve the quality of life in the stroke survivors. This non-invasive technique involves stimulating either the unaffected or affected hemisphere with low-frequency or high-frequency pulses, respectively. The goal is to rebalance brain activity and promote functional recovery post-stroke . While previous research has extensively explored the effects of rTMS on post-stroke upper limb motor recovery, the underlying neurophysiological mechanisms remain less understood. Specifically, the role of intracortical circuits, particularly GABAergic interneurons, in mediating these effects is not well-established. Additionally, the impact of rTMS on heart rate variability, and its association with frontal vagal network activity is under-investigated. Furthermore, there is a paucity of research on the effectiveness of rTMS in Indian stroke patients and the associated neurophysiological changes, considering the potential influence of ethnicity on treatment outcomes. Thus, the present study aims to investigate the impact of rTMS using neurophysiological and clinical outcomes in post-stroke upper limb recovery. |