AphasiaNCT04625790
Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Post-stroke Anomic Aphasia
A study testing Repetitive transcranial magnetic stimulation and Speech therapy in people with Aphasia and Aphasia, Anomic, run by Ege University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Aphasia, Aphasia, Anomic, Stroke
- What is being tested?
- Repetitive transcranial magnetic stimulation and Speech therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Nov 2020to 6 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Severe cognitive impairment
- Having a history of previous epilepsy
- Visual and auditory impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University Faculty of Medicine
Izmir, 35100
About this study
Official title: The Effectiveness of Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Patients With Post-stroke Anomic Aphasia
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.
- Conditions
- Aphasia, Aphasia, Anomic, Stroke
- Being tested
- Repetitive transcranial magnetic stimulation, Speech therapy
- Medical subject headings
- Aphasia, Anomia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
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.
Speech therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | 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. Receives: Device: Repetitive transcranial magnetic stimulation; Other: Speech therapy |
| Control group | Placebo comparator | 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. Receives: Other: Speech therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (2)
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.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start6 Nov 2020
- Primary completion6 Nov 2021
- Study completion6 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kadir Kara M.D, Ege University
- Investigators
- Kadir Kara, MD, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625790
- Sponsor's protocol ID
- Anomia-rTMS
- Status last verified
- Aug 2022
- First submitted
- 6 Nov 2020
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Patients With Post-stroke Anomic Aphasia
- ClinicalTrials.gov ID
- NCT04625790
- Acronym / sponsor ID
- Anomia-rTMS
- Conditions
- Aphasia, Aphasia, Anomic, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 6 Nov 2021 (actual)
- Study completion
- 6 Nov 2021 (actual)
- First posted
- 12 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Repetitive transcranial magnetic stimulation, Other: Speech therapyAfter 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. |
| Control group | Placebo comparator | Other: Speech therapyThis 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulationTranscranial 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. | Device | Study group |
| Speech therapySpeech 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. | Other | Control group, Study group |
Primary outcome
Ege Aphasia Test
Time frame: 2 weeks
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 secondary outcomes
Stroke and Aphasia Quality of Life Scale ( SAQOL-39 )
Time frame: 2 weeks
Mini Mental Test(MMT)
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Results publication1- 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kadir Kara, MD principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation and Speech therapy in people with Aphasia and Aphasia, Anomic, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ege Aphasia Test (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04625790, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.