Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Post-stroke Anomic Aphasia

Stroke Clinical Trial

Official title:

The Effectiveness of Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Patients With Post-stroke Anomic Aphasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04625790
• Other study ID #: Anomia-rTMS
• Status: Completed
• Phase: N/A
• Start date: November 6, 2020
• Est. completion date: November 6, 2021

Study information

• Verified date: August 2022
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 6, 2021
• Est. primary completion date: November 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anomia
• Aphasia
• Aphasia, Anomic
• Communication Disorders
• Stroke

Intervention

Device:
• Repetitive transcranial magnetic stimulation
Transcranial Magnetic Stimulation(TMS) has been used for diagnostic and therapeutic purposes in the treatment of many neurological and psychiatric diseases such as stroke, multiple sclerosis, myelopathy, amyotrophic lateral sclerosis, movement disorders, epilepsy, and depression. It is a way to stimulate the targeted areas in the cerebral cortex without invasive methods. The application of TMS in the aphasia usually consists of repetitive stimulations, in order to activate or deactivate the target area. In this study, 10 sessions of 1-Hz low frequency rTMS for 20 minutes will be applied to the inferior frontal gyrus of the right frontal lobe.

Other:
• Speech therapy
Speech therapy will be given to each patient by the same therapist, and the treatment will last 10 days, 60 minutes a day. It will consist of exercises to improve the articulation and comprehension.

Locations

Country	Name	City	State
Turkey	Ege University Faculty of Medicine	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

1- Öge EA. Nöroloji, Istanbul Üniversitesi Istanbul Tip Fakültesi Temel ve Klinik Bilimler Ders Kitaplari. Nobel Tip, 2004. 2- Balkan S. Serebrovasküler hastaliklar. Günes kitabevi , Ankara 2002 3- Atamaz Çalis, F., "Dil Islevleri ve Testleri", Klinik Nör

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ege Aphasia Test	Ege aphasia test (EAT): The test battery acquired in 2011 and used in the study consists of 8 subtests: speech style and characteristics, apraxia assessment, auditory / verbal comprehension, repetition, naming, visual understanding / reading, drawing figures / writing / sentences, mathematics. Although there is variability in the scoring of the EAT according to the subtests, generally 0 points are given to correct answers, and 1, 2 or more points are given to repeated and incorrect answers. The validity and reliability of the test was shown in 2013 by Atamaz et al.	2 weeks
Secondary	Stroke and Aphasia Quality of Life Scale ( SAQOL-39 )	Stroke and Aphasia Quality of Life Scale(SAQOL-39): This scale consists of 4 subscales (physical, communication, psychosocial and energy) and 39 items. Its validity, reliability and usability have been proven in individuals who develop aphasia after stroke. The overall score ranges from 1 to 5, with higher scores being associated with better outcomes.	2 weeks
Secondary	Mini Mental Test(MMT)	Mini mental test includes 5 domains: Orientation, recording memory, attention and calculation, recall and language. It consists of 11 items and is evaluated over the total score of 30. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment.	2 weeks