| CTRI Number |
CTRI/2021/08/036026 [Registered on: 31/08/2021] Trial Registered Prospectively |
| Last Modified On: |
22/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of rTMS in post-stoke spasticity. |
|
Scientific Title of Study
|
To evaluate the effectiveness of add on repetitive transcranial magnetic stimulation (rTMS) in management of post-stroke spasticity a randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeev Kumar Bhoi |
| Designation |
Associate Professor |
| Affiliation |
Aiims Bhubaneswar |
| Address |
Department of Neurology AIIMS Bhubaneswar Sijua, Dumuduma Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9919787978 |
| Fax |
|
| Email |
bhoisanjeev@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Kumar Bhoi |
| Designation |
Associate Professor |
| Affiliation |
Aiims Bhubaneswar |
| Address |
Department of Neurology AIIMS Bhubaneswar Sijua, Dumuduma Bhubaneswar
ORISSA
751019
India |
| Phone |
9919787978 |
| Fax |
|
| Email |
bhoisanjeev@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yuvraj Lahre |
| Designation |
Senior Resident |
| Affiliation |
Aiims Bhubaneswar |
| Address |
Department of Neurology AIIMS Bhubaneswar Sijua, Dumuduma Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
8983229469 |
| Fax |
|
| Email |
yuvi.10170@gmail.com |
|
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Source of Monetary or Material Support
|
| Aiims Bhubaneswar, Odisha |
|
|
Primary Sponsor
|
| Name |
Aiims Bhubaneswar |
| Address |
Sijua, Dumuduma Bhubaneswar Khordha, ODISHA, 751019 India |
| 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 |
| Sanjeev Kumar Bhoi |
Aiims |
Department of Neurology AIIMS Bhubaneswar. Sijua, Dumuduma Bhubaneswar
Khordha
ORISSA |
9919787978
bhoisanjeev@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Bhubaneswar Institute Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physiotherapy |
standard physiotherapy for spasticity |
| Intervention |
repetitive transcranial magnetic stimulation (rTMS) |
Each treatment arm will consist of 3 daily treatment sessions. One treatment session will consist of 1000 pulses of 1 Hz rTMS at an intensity of 90% of resting motor threshold (duration 15 minutes) applied to the primary motor area of the contra-lesional hemisphere |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. First-time stroke
2. Stroke at least three months prior to onset of study with chronic sequela of spasticity
3. Stroke location- either cortical or subcortical
4. Stroke type- either hemorrhagic or ischemic
5. Stroke hemisphere- either left or right, dominant or non- dominant hemisphere
6. 18 years of age or older
7. Gender- either male or female
8. Ability to follow three-step directions
9. Demonstration of 10 degrees of active extension at the metacarpophalangeal joint and wrist of the paretic upper extremity
10. Sufficient ambulation or wheelchair mobility to allow subject to present to treatment and testing areas with minimum assistance
|
|
| ExclusionCriteria |
| Details |
1. History of seizure within the past two years
2. Inability to follow three-step directions
3. Anosognosia
4. Moderate to severe receptive aphasia
5. Inability to give informed consent
6. Premorbid spasticity or neurologic impairment prior to stroke
7. Co-morbidities impairing upper extremity function such as fracture or deformity
8. Indwelling metal or medical devices incompatible with TMS
9. Pregnancy
10. Bi-hemispheric or multifocal stroke
11. Severe dementia
12. Neurolytic injection within the 3 months prior to onset of study or planned neurolytic injection during study period
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in Baseline modified Modified Ashworth Scale score from Day 1 (Pre-treatment) to Day 5 (Post-treatment), and at 1 month |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Motor function improvement will be assessed through digital hand dynamometer |
1 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2021 |
| Date of Study Completion (India) |
31/05/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke is a common acute neurovascular disorder which causes many
disabilities leading to long-term limitations of daily living activities.
Although motor deficit is most common consequence of stoke. Nonmotor
symptoms are also relevant and often equally disabling. Till
date there is no validated treatment that is able to restore the impaired
functions by a complete recovery of the damaged tissue. Currently the stroke
management basically consists of reducing the initial ischemia in the penumbra,
preventing future complications, and promoting a functional recovery using
physiotherapy, speech therapy, occupational therapy, and other conventional
treatments. Stroke, causes shift in the balance between the inhibition and
excitation of both the affected and contralateral hemisphere, consisting of
increased excitability and disinhibition. The
role of the uninjured hemisphere seems to be of utmost significance in post-stroke clinical and functional recovery. Unaffected hemisphere may contribute
to the functional recovery after a stroke through the replacement of the lost
functions of the affected areas.
Spasticity involves exaggerated stretch reflexes that create
stiffness in muscles with associated loss of motion and functional control.It is
a common complication of stroke that affects quality of life of patients.
Available treatments for the post-stroke spasticity includes physiotherapy,
medications, and sometimes surgery. Each of these has its own limitations like
feasibility, affordability and compliance. So exploration of alternative modes
of treatment is necessary. Repetitive Transcranial Magnetic Stimulation (rTMS)
can play potential role in reducing post-stroke spasticity. Repetitive Transcranial magnetic stimulation (rTMS) is a feasible
and painless neurophysiological technique widely used for, therapeutic
purposes. It
generates sub or suprathreshold currents in the human cortex by electromagnetic
induction. Two
types of rTMS modalities are available. First one is high-frequency (HF-rTMS)
stimulation (>1 Hz), which increases motor cortex excitability of the
stimulated area and the second is low-frequency (LF-rTMS) stimulation (⩽1 Hz) which usually produces a decrease in excitability.(13,14)
Coil position during rTMS session is defined by the place where
motor threshold (MT) is recorded. MT is defined as lowest transcranial magnetic
stimulation intensity required to produce a motor evoke potential (MEP) of
amplitude >50µv in at least 6 of 10 trials. The mechanisms by which rTMS
modulates the brain seems to be related to the phenomenon of long-term
potentiation (LTP) and long-term depression (LTD).(15) Role
of rTMS has already been proven in other disease like depression, migraine
prophylaxis with minimal side effects. Through this study we also want to assess the role of rTMS in
improvement of power of upper limb. Also we will assess improvement in other
domains such as mood, memory ability to communicate etc. So through this study
we will be able to assess overall improvement in stroke patients after the
rTMS.
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