Role of rTMS in post-stoke spasticity.

Completed

Conditions: Spastic hemiplegia,

Registration Number: CTRI/2021/08/036026

Lead Sponsor: Aiims Bhubaneswar

Brief Summary: Stroke is a common acute neurovascular disorder which causes manydisabilities leading to long-term limitations of daily living activities.Although motor deficit is most common consequence of stoke. Nonmotorsymptoms are also relevant and often equally disabling. Tilldate there is no validated treatment that is able to restore the impairedfunctions by a complete recovery of the damaged tissue. Currently the strokemanagement basically consists of reducing the initial ischemia in the penumbra,preventing future complications, and promoting a functional recovery usingphysiotherapy, speech therapy, occupational therapy, and other conventionaltreatments.Stroke, causes shift in the balance between the inhibition andexcitation of both the affected and contralateral hemisphere, consisting ofincreased excitability and disinhibition. Therole of the uninjured hemisphere seems to be of utmost significance in post-stroke clinical and functional recovery. Unaffected hemisphere may contributeto the functional recovery after a stroke through the replacement of the lostfunctions of the affected areas.

Spasticity involves exaggerated stretch reflexes that createstiffness in muscles with associated loss of motion and functional control.It isa 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 likefeasibility, affordability and compliance. So exploration of alternative modesof treatment is necessary. Repetitive Transcranial Magnetic Stimulation (rTMS)can play potential role in reducing post-stroke spasticity. Repetitive Transcranial magnetic stimulation (rTMS) is a feasibleand painless neurophysiological technique widely used for, therapeuticpurposes. Itgenerates sub or suprathreshold currents in the human cortex by electromagneticinduction. Twotypes of rTMS modalities are available. First one is high-frequency (HF-rTMS)stimulation (>1 Hz), which increases motor cortex excitability of thestimulated area and the second is low-frequency (LF-rTMS) stimulation (â©½1 Hz) which usually produces a decrease in excitability.(13,14)

Coil position during rTMS session is defined by the place wheremotor threshold (MT) is recorded. MT is defined as lowest transcranial magneticstimulation intensity required to produce a motor evoke potential (MEP) ofamplitude >50Âµv in at least 6 of 10 trials. The mechanisms by which rTMSmodulates the brain seems to be related to the phenomenon of long-termpotentiation (LTP) and long-term depression (LTD).(15) Roleof rTMS has already been proven in other disease like depression, migraineprophylaxis with minimal side effects. Through this study we also want to assess the role of rTMS inimprovement of power of upper limb. Also we will assess improvement in otherdomains such as mood, memory ability to communicate etc. So through this studywe will be able to assess overall improvement in stroke patients after therTMS.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Motor function improvement will be assessed through digital hand dynamometer	1 month

Trial Locations

Locations (1): Aiims
🇮🇳
Khordha, ORISSA, India
Aiims
🇮🇳Khordha, ORISSA, India
Sanjeev Kumar Bhoi
Principal investigator
9919787978
bhoisanjeev@gmail.com