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

Primary Purpose

Aphasia, Aphasia, Anomic, Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
Speech therapy
Sponsored by
Ege University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ege University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Control group

Arm Description

After randomization, this group will take 10 sessions of 1-Hz low frequency rTMS will be applied to the inferior frontal gyrus of the right frontal lobe for 20 minutes during the stroke treatment process before 10 days of speech therapy. Speech therapy will be given to each patient by the same therapist who is qualified in this field, and the treatment will last 10 days, 60 minutes a day.

This group will take 10 sessions of sham rTMS for 20 minutes during the stroke treatment process before 10 days of speech therapy. The sham therapy will consist of positioning the coil on the cranium at the same spot, but without a magnetic stimulation, only with the device open and the sounds will be audible. Speech therapy will be given to each patient by the same therapist who is qualified in this field, and the treatment will last 10 days, 60 minutes a day.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 6, 2020
Last Updated
August 6, 2022
Sponsor
Ege University
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1. Study Identification

Unique Protocol Identification Number
NCT04625790
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 6, 2020 (Actual)
Primary Completion Date
November 6, 2021 (Actual)
Study Completion Date
November 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ege University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia, Aphasia, Anomic, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants will not know their groups, and the transcranial magnetic stimulation applications will be done in similar conditions, except for no stimulation with the position of the coil. The masking will also be done for the care provider, investigator and the outcomes assessor, as the evaluator and the researcher who provides the randomization will be different, and the data recording will be kept without implying the groups.
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
After randomization, this group will take 10 sessions of 1-Hz low frequency rTMS will be applied to the inferior frontal gyrus of the right frontal lobe for 20 minutes during the stroke treatment process before 10 days of speech therapy. Speech therapy will be given to each patient by the same therapist who is qualified in this field, and the treatment will last 10 days, 60 minutes a day.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
This group will take 10 sessions of sham rTMS for 20 minutes during the stroke treatment process before 10 days of speech therapy. The sham therapy will consist of positioning the coil on the cranium at the same spot, but without a magnetic stimulation, only with the device open and the sounds will be audible. Speech therapy will be given to each patient by the same therapist who is qualified in this field, and the treatment will last 10 days, 60 minutes a day.
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Speech therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ege Aphasia Test
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Stroke and Aphasia Quality of Life Scale ( SAQOL-39 )
Description
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.
Time Frame
2 weeks
Title
Mini Mental Test(MMT)
Description
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.
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kadir Kara, MD
Organizational Affiliation
Ege University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ege University Faculty of Medicine
City
İzmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
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Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Post-stroke Anomic Aphasia

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