Clinical trial NCT06223451: Evaluation of the Efficacy of Low-Frequency Repetitive Transcranial Magnetic Stimulation on Unilateral Neglect in Patients With Subacute-Chronic Phase After Ischemic Stroke
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neglect, Hemispatial
Keywords: İskemic stroke
Transcranial magnetic stimulation
Unilateral neglect
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Star Cancellation Test
timeFrame: 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
measure: Line Bisection Test
timeFrame: 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:
measure: Catherine Bergego Scale
timeFrame: 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
measure: Stroke Impact Scale
timeFrame: 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
measure: Mini-Mental State Examination
timeFrame: 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
measure: Brunnstrom Recovery Stage
timeFrame: 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
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital Physical Therapy and Rehabilitation Hospital
state: Bilkent-Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Ayşenur Mert Kurt, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara City Hospital Bilkent
name: Zeynep A Kurtaran, Professor Doctor
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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/s00221-014-4112-9. Epub 2014 Oct 21.