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

NCT06223451 | Completed

• 1 other identifier: 10026592
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neglect, Hemispatial

Keywords

İskemic stroke; Transcranial magnetic stimulation; Unilateral neglect

Outcome Measures

Primary Outcomes (2)

• Star Cancellation Test

  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

  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 Outcomes (4)

• Catherine Bergego Scale

  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

  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

  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

  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

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

SHAM COMPARATOR

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

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital

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

Location

Related Publications (3)

• Cha HG, Kim MK. The effects of repetitive transcranial magnetic stimulation on unilateral neglect of acute stroke patients: A randomised controlled trial. Hong Kong Physiother J. 2015 Dec;33(2):53-58. doi: 10.1016/j.hkpj.2015.04.001. Epub 2015 Jun 12.

  PMID: 30930568 RESULT

• Brighina F, Bisiach E, Oliveri M, Piazza A, La Bua V, Daniele O, Fierro B. 1 Hz repetitive transcranial magnetic stimulation of the unaffected hemisphere ameliorates contralesional visuospatial neglect in humans. Neurosci Lett. 2003 Jan 16;336(2):131-3. doi: 10.1016/s0304-3940(02)01283-1.

  PMID: 12499057 RESULT

• Kim YK, Jung JH, Shin SH. A comparison of the effects of repetitive transcranial magnetic stimulation (rTMS) by number of stimulation sessions on hemispatial neglect in chronic stroke patients. Exp Brain Res. 2015 Jan;233(1):283-9. doi: 10.1007/s00221-014-4112-9. Epub 2014 Oct 21.

  PMID: 25332169 RESULT

MeSH Terms

Conditions

Perceptual Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşenur Mert Kurt, Medical Doctor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• Zeynep A Kurtaran, Professor Doctor

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 25, 2024
• Study Start: June 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: April 15, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)