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Completed

NCT Number: NCT06223451

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

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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Key information

Conditions

Neglect, Hemispatial Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

Ankara, Bilkent-Çankaya, 06800, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Repetitive Transcranial Magnetic Stimulation

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

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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