The Effect Of Transcranial Magnetic Stimulation In Patients With Stroke

NCT ID: NCT04562415

Last Updated: 2020-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-05-01

Brief Summary

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This study is aimed to investigate the effect of continuous theta burst stimulation (cTBS) and low frequency repetitive transcranial magnetic stimulation (rTMS) on upper extremity spasticity and functional recovery in patients with chronic ischemic stroke.

Detailed Description

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A sham-controlled double-blind randomized study was undertaken. 20 patients with chronic stroke were randomized into active rTMS group (n=7), active cTBS group (n=7) and sham cTBS group (n=6). In the active rTMS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In the active cTBS group, 10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. Sham cTBS was applied in the same protocol but using sham coil. Within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities under the guidance of a physiotherapist, regardless of which group they were in. Upper Extremity Fugl-Meyer Motor Function Scale, Modified Ashworth Scale (MAS), Functional Independence Measure (FIM), Motor Activity Log-28 (MAL-28) and Brunnstrom upper extremity and hand motor recovery stage were assessed at pre-treatment, post-treatment and follow up at 4 weeks.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Active rTMS group

chronic ischemic stroke patients receiving active low frequency repetitive transcranial magnetic stimulation therapy and physical therapy

Group Type ACTIVE_COMPARATOR

Active Repetitive Transcranial Magnetic Stimulation Therapy

Intervention Type DEVICE

10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.

Active cTBS group

chronic ischemic stroke patients receiving active continuous theta burst stimulation therapy and physical therapy

Group Type ACTIVE_COMPARATOR

Active Continuous Theta Burst Stimulation Therapy

Intervention Type DEVICE

10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.

Sham cTBS group

chronic ischemic stroke patients receiving sham continuous theta burst stimulation therapy and physical therapy

Group Type SHAM_COMPARATOR

Sham Continuous Theta Burst Stimulation Therapy

Intervention Type DEVICE

10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and sham cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.

Interventions

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Active Repetitive Transcranial Magnetic Stimulation Therapy

10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.

Intervention Type DEVICE

Active Continuous Theta Burst Stimulation Therapy

10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.

Intervention Type DEVICE

Sham Continuous Theta Burst Stimulation Therapy

10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and sham cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.

Intervention Type DEVICE

Other Intervention Names

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Rehabilitation Program Rehabilitation Program Rehabilitation Program

Eligibility Criteria

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Inclusion Criteria

* ischemic stroke with a disease interval of 6 months to 2 years
* aged between 18-80 years
* Mini mental test score ≥ 24
* upper limb Brunnstrom recovery stage 3 to 5
* upper extremity (elbow, wrist and finger) spasticity level Modified Ashworth Scale (MAS) 1+ to 3

Exclusion Criteria

* hemorrhagic stroke
* history of epilepsy
* a cardiac pacemaker
* pregnancy
* history of previous stroke or ischemic attack
* neurological diseases other than stroke
* metallic implant in brain or scalp (including cochlear implant)
* previous brain surgery
* orthopedic disease that prevents upper extremity movements
* poor general health (due to heart failure, chronic obstructive pulmonary disease, severe infection, etc.)
* diagnosis of malignancy
* injections of botulinum toxin in the last 6 months for the affected upper extremity
* drug or dosage changes of anti-spasticity medications in the last 1 month period
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yasin Demir

Clinical Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bilge Yılmaz, Professor,MD

Role: STUDY_DIRECTOR

Gaziler PMR, Training and Research Hospital, Department of PMR

Ömer Kuzu, MD

Role: PRINCIPAL_INVESTIGATOR

Gaziler PMR, Training and Research Hospital, Department of PMR

Locations

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Gaziler PMR, Training and Research Hospital, Department of PMR

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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5

Identifier Type: -

Identifier Source: org_study_id

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