Clinical trial NCT04625790: Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Post-stroke Anomic Aphasia
Official title: The Effectiveness of Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Patients With Post-stroke Anomic Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Aphasia, Anomic
Stroke
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to observe the effects of speech therapy and transcranial magnetic stimulation therapy in patients who develop anomic aphasia after stroke. Patients meeting the inclusion criteria will be randomly divided into groups. In the repetitive transcranial magnetic stimulation (rTMS) treatment group, a total of 10 sessions, 1 session per day, will be applied to the right inferior frontal gyrus area with a frequency of 1 Hz for 20 minutes. The control group patients will be given speech therapy in the same way, but no active magnetic stimulation will be given in rTMS sessions (sham application). Speech therapy will be given to each patient by the same physiotherapist, and the treatment will last a total of 10 days, 60 minutes a day. Minimental test (MMT), Ege aphasia test, aphasia quality of life scale (SAQOL-39) will be filled in to the patients before and after the treatment.


Eligibility criteria: Inclusion Criteria:

* Stroke diagnosed with cranial MR examination causing unilateral hemiplegia
* Post-stroke patients with anomic aphasia
* 40-70 years
* Being able to read the basic instructions
* Medically and neurologically stable patients

Exclusion Criteria:

* Clinical condition that will constitute a contraindication to TMS (metallic implant, Cardiac pacemaker, pregnancy, breastfeeding, epilepsy, head trauma...)
* Having previously had TMS treatment
* Presence of Life-threatening disease and/or active systemic disease (chronic disease, malignancy ...)
* Alcohol or drug addiction
* Presence of neurodegenerative or psychiatric disorders
* Pregnancy or breastfeeding status
* Severe cognitive impairment
* Having a history of previous epilepsy
* Visual and auditory impairment

Primary outcomes:
measure: Ege Aphasia Test
timeFrame: 2 weeks
Secondary outcomes:
measure: Stroke and Aphasia Quality of Life Scale ( SAQOL-39 )
timeFrame: 2 weeks
measure: Mini Mental Test(MMT)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine
Study officials:
affiliation: Ege University
name: Kadir Kara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 1- Öge EA. Nöroloji, İstanbul Üniversitesi İstanbul Tıp Fakültesi Temel ve Klinik Bilimler Ders Kitapları. Nobel Tıp, 2004. 2- Balkan S. Serebrovasküler hastalıklar. Güneş kitabevi , Ankara 2002 3- Atamaz Çalış, F., "Dil İşlevleri ve Testleri", Klinik Nöropsikoloji ve Nöropsikiyatrik Hastalıklar, ed. E. Kumral, 287-324, Güneş Tıp Kitabevleri, 2013 4- Sinanović O, Mrkonjić Z, Zukić S, Vidović M, Imamović K. Post-stroke language disorders. Acta Clin Croat. 2011 Mar;50(1):79-94. 5- Bakheit AM. Drug treatment of poststroke aphasia. Future drugs, expert review of neurotherapeutics 2004. 6- Brady MC, Kelly H, Godwin J, Enderby P. Speech and language therapy for aphasia following stroke. Cochrane Database Syst Rev. 2012 May 16;5:CD000425 7- Barker AT, Jalinous R, Freeston IL. Non-invasive magnetic stimulation of human motor cortex. Lancet. 1985 May 11;1(8437):1106-7. 8- Barker AT. The history and basic principles of magnetic nerve stimulation. In: Pascual-Leone A, Davey NJ, Rothwell J, Wassermann EM, Puri BK (Eds). Handbook of Transcranial Magnetic Stimulation. Oxford University Press Inc, New York, 2002, pp 3-17. 9- Chung MG, Lo WD. Noninvasive brain stimulation: the potential for use in the rehabilitation of pediatric acquired brain injury. Arch Phys Med Rehabil. 2015 Apr;96(4 Suppl):S129-37. 10- Hu X yan, Zhang T, Rajah GB, et al. Effects of different frequencies of repetitive transcranial magnetic stimulation in stroke patients with non-fluent aphasia: a randomized, sham-controlled study. Neurol Res. 2018;40(6):459-465. doi:10.1080/01616412.2018.1453980 11- Rubi-Fessen I, Hartmann A, Huber W, et al. Add-on Effects of Repetitive Transcranial Magnetic Stimulation on Subacute Aphasia Therapy: Enhanced Improvement of Functional Communication and Basic Linguistic Skills. A Randomized Controlled Study. Arch Phys Med Rehabil. 2015;96(11):1935- 1944.e2. doi:10.1016/j.apmr.2015.06.017 12- Calis Atamaz F, Yağız On A, Durmaz B. Validity and Reliability of a New Test for Turkish-Speaking Aphasic Patients: Ege Aphasia Test . Neurorehab 2013;32(1):157-63 13- Atamaz Calis F, Celik S, Demir O, Aykanat D, Yagiz On A. The psychometric properties of the Turkish Stroke and Aphasia Quality Of Life Scale-39. Int J Rehabil Res. 2016 Jun;39(2):140-4. 14- Dergisi P. Cornell Demansta Depresyon Ölçeği'nin Türk Yaşlı Toplumunda Geçerlik ve Güvenilirliği. Depression. 2003;14(4):263-271.