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

January 6, 2025 updated by: Ayşenur Mert, Ankara City Hospital Bilkent
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bilkent-Çankaya
      • Ankara, Bilkent-Çankaya, Turkey, 06800
        • Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Device: 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.
Sham Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Star Cancellation Test
Time Frame: Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
The star cancellation test, there are 13 letters and 10 short words placed between 52 large and 56 small stars. The patient is required to mark all the small stars using a pencil. To demonstrate how it should be done, two small stars are selected from the central section.Scores are calculated by identifying the ratio of the number of removed small stars/the total number of small stars 100 for each empty half-space on the left and right sides.
Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
Line Bisection Test
Time Frame: Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
The Line Bisection Test is a rapid measure to detect the presence of unilateral spatial neglect. To complete the test, a pencil mark is placed in the middle of 18 horizontal lines. The test is scored by measuring the deviation from the actual center of the line.
Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catherine Bergego Scale
Time Frame: Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
Catherine Bergego Scale: Analyzes the functioning of the neglect patient in daily life situations. Each question is scored from zero to three, where 0 corresponds to the absence of neglect for the given task; 1 represents mild neglect, 2 represents moderate neglect, and 3 corresponds to severe unilateral neglect. If the total score is between 1 and 10, it is considered mild neglect; if it is between 11 and 20, it is considered moderate neglect; and if it is between 21 and 30, it is considered severe neglect.
Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
Stroke Impact Scale
Time Frame: Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
This scale, which aims to assess the quality of life after stroke by patients themselves or their caregivers, consists of 8 subsections and 59 questions. Each question is scored by evaluating the difficulty experienced in the last week by giving 5 points. The total score ranges from 0-100 and a high score indicates improvement in stroke patients.
Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
Mini-Mental State Examination
Time Frame: Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
It is a screening test used to assess the cognitive status of patients. It is categorized under 5 main headings: orientation, recording memory, attention and calculation, recall and language. It is evaluated over a total of 30 points.
Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
Brunnstrom Recovery Stage
Time Frame: Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment
The test is used to assess post-stroke motor recovery. The motor development stages of hemiplegic patients are graded on a scale of 1-6.stage 1 flaccid period is rated as the worst stage, stage 6 is rated as the best stage with isolated movements.
Before treatment(initial), two weeks after the beginning of the treatment, four weeks after the beginning of the treatment, six weeks after the beginning of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara City Hospital Bilkent

Investigators

  • Principal Investigator: Ayşenur Mert Kurt, Medical Doctor, Ankara City Hospital Bilkent
  • Study Director: Zeynep A Kurtaran, Professor Doctor, Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2023

Primary Completion (Actual)

February 15, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

January 4, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10026592

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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