Evaluation of the Efficacy of Low-Frequency Repetitive Transcranial Magnetic Stimulation on Unilateral Neglect in Patients With Subacute-Chronic Phase After Ischemic Stroke

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

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-15

Study Completion Date

2024-04-15

Brief Summary

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The aim of this study was to randomize stroke patients with unilateral neglect into 2 groups, active and sham groups, and to examine the effects of active inhibitory repetitive transcranial magnetic stimulation on the reduction of neglect symptoms, functional recovery and independence of these patients in activities of daily living.

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Detailed Description

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Patients diagnosed with ischemic stroke at least 1 month ago, with unilateral neglect, receiving inpatient rehabilitation at stroke clinics, and meeting the study criteria for both genders between the ages of 18-80, will be divided into two groups. A total of 22 stroke patients, informed about the applied treatments and potential risks, and providing written consent, will be randomly assigned to receive either active repetitive transcranial magnetic stimulation (rTMS) combined with conventional rehabilitation (Mirror therapy and Visual scanning training) or sham (imitation) repetitive transcranial magnetic stimulation (rTMS) combined with conventional rehabilitation.

The study will include 22 randomly selected patients with neglect, with 11 planned in the intervention group and 11 in the control group. Patients will receive active rTMS or sham rTMS for a total of 10 sessions, each lasting 20 minutes, alongside conventional rehabilitation over a period of 2 weeks. rTMS applications will be conducted once daily before the daily rehabilitation program.

Conditions

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Neglect, Hemispatial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Active repetitive transcranial magnetic stimulation in stroke patients with unilateral neglect.

Inhibitory repetitive transcranial magnetic stimulation will be applied to 11 patients with unilateral neglect due to ischemic stroke under the supervision of a doctor for a total of 10 sessions over 2 weeks with conventional rehabilitation. Each session will last for 20 minutes,total of 1200 pulses, 1 Hz repetitive transcranial manyetic stimulation over the unaffected left posterior parietal cortex.

Group Type ACTIVE_COMPARATOR

Active Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation method that can alter the excitability of the motor area by generating a magnetic field through a coil. Low-frequency stimulation (\<1 Hz) applied with rTMS has inhibitory effects. Repetitive transcranial magnetic stimulation has a neurorehabilitative role as it can modulate the excitability of targeted brain areas. Inhibitory repetitive transcranial magnetic stimulation will be applied to 11 patients with unilateral neglect due to ischemic stroke under the supervision of a doctor for a total of 10 sessions over 2 weeks with conventional rehabilitation.Each session will last for 20 minutes,total of 1200 pulses, 1 Hz repetitive transcranial manyetic stimulation over the unaffected left posterior parietal cortex.

Sham repetitive transcranial magnetic stimulation in stroke patients with unilateral neglect.

Patients in the sham group will receive sham transcranial magnetic stimulation with sham coil for 20 minutes a day, 10 sessions in total, together with conventional rehabilitation.

Group Type SHAM_COMPARATOR

Sham Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

Patients in the sham group will receive sham transcranial magnetic stimulation with sham coil for 20 minutes a day, 10 sessions in total, together with conventional rehabilitation.

Interventions

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Active Repetitive Transcranial Magnetic Stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation method that can alter the excitability of the motor area by generating a magnetic field through a coil. Low-frequency stimulation (\<1 Hz) applied with rTMS has inhibitory effects. Repetitive transcranial magnetic stimulation has a neurorehabilitative role as it can modulate the excitability of targeted brain areas. Inhibitory repetitive transcranial magnetic stimulation will be applied to 11 patients with unilateral neglect due to ischemic stroke under the supervision of a doctor for a total of 10 sessions over 2 weeks with conventional rehabilitation.Each session will last for 20 minutes,total of 1200 pulses, 1 Hz repetitive transcranial manyetic stimulation over the unaffected left posterior parietal cortex.

Intervention Type DEVICE

Sham Repetitive Transcranial Magnetic Stimulation

Patients in the sham group will receive sham transcranial magnetic stimulation with sham coil for 20 minutes a day, 10 sessions in total, together with conventional rehabilitation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* First-time ischemic stroke
* Patients at least 1 month after the stroke
* To be aged between 18 and 80 years old
* Presence of unilateral neglect
* No significant cognitive impairment (MMSE \> 24 points)
* Signing an informed consent form indicating willingness to participate in the study

Exclusion Criteria

* Epilepsy, history of seizure
* Metallic implant in the area of stimulation (cochlear implant, brain pacemaker, drug pump etc.)
* Presence of cardiac pacemaker
* Severe general condition disorder or accompanying neurological disease
* Aphasi
* Pregnancy
* Under 18 years of age and over 80 years of age
* Visual impairment

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No