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

Neglect, Hemispatial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06223451
• Other study ID #: 10026592
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: January 2024
• Source: Ankara City Hospital Bilkent
• Contact: Zeynep A Kurtaran, Professor Doctor
• Phone: +905057760665
• Email: aydankurtaran[@]mynet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: April 15, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Neglect, Hemispatial
• Perceptual Disorders

Intervention

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 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.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital	Ankara	Bilkent-Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. d — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Catherine Bergego Scale	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
Secondary	Stroke Impact Scale	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
Secondary	Mini-Mental State Examination	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
Secondary	Brunnstrom Recovery Stage	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