AphasiaNCT05450341
Efficacy of Low-frequency rTMS in Aphasia
A study testing rTMS over right frontal target and rTMS over right temporal target in people with Aphasia, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
In a randomized controlled trial, efficacy of low-frequency, inhibitory rTMS will be examined in rehabilitation of acquired aphasia. Two cortical sites will be targeted: Right-hemispheric homologues of Broca's and Wernicke's areas. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aphasia
- What is being tested?
- rTMS over right frontal target and rTMS over right temporal target
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jul 2022to Mar 2023
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right-handedness,
- Normal or corrected-to-normal vision and hearing,
- Aphasia following cerebrovascular accident,
- Cerebrovascular accident at least 6 months prior to enrolment in the study,
- Satisfying current TMS safety guidelines (Rossi et al. 2009, 2021), which are:
- No previous history of epilepsy,
- No implant (e.g., cochlear implant) or stimulator (e.g., deep brain stimulation) in the head which may interact with the magnetic field,
- No use of central nervous system active drugs that lower seizure threshold (as listed in the aforementioned guidelines)
Who cannot join
- Left-handedness, ambidexterity,
- Impaired and uncorrected vision or hearing,
- No aphasia symptoms following cerebrovascular accident,
- Time since cerebrovascular accident less than 6 months,
- Violating current TMS safety guidelines (Rossi et al. 2009, 2021). In other words:
- Having a previous history of epilepsy,
- Having an implant (e.g., cochlear implant) or stimulator (e.g., deep brain stimulation) in the head which may interact with the magnetic field,
- Taking central nervous system active drugs that lower seizure threshold (as listed in the aforementioned guidelines)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İstanbul Medipol University, Speech, Language and Swallowing Therapy and Research Center (MEDKOM)
Istanbul, 34815
Talat Bulut, PhD, 444 85 44 ext. 1890, tbulut@medipol.edu.tr
About this study
Official title: Efficacy of Low-frequency Repetitive Transcranial Magnetic Stimulation on Rehabilitation of Aphasia
In a randomized controlled trial, efficacy of low-frequency, inhibitory rTMS will be examined in rehabilitation of acquired aphasia. Two cortical sites will be targeted: Right-hemispheric homologues of Broca's and Wernicke's areas.
In addition to cognitive screening prior to onset of rTMS, language assessments will be conducted before, during and after the intervention. An eyetracking-while-listening experiment will also be conducted before and after the intervention to investigate morphosyntactic processing.
Read the detailed description
Efficacy of low-frequency (1hz), inhibitory rTMS will be examined in rehabilitation of acquired aphasia. Two cortical sites will be targeted: Right-hemispheric homologues of Broca's and Wernicke's areas. In other words, right frontal and right temporal sites will be targeted.
In addition to cognitive screening prior to onset of rTMS, language assessments will be conducted before, during and after the intervention. The language assessment will be conducted using the Turkish Aphasia Language Assessment Test (ADD) and sets of pictures used to assess naming performance. ADD will be carried out before and after the intervention. Six picture sets will be used, one at baseline, four on different days during the intervention, and the last one immediately after the last day of the intervention. Cognitive screening will be conducted at baseline using the digit span test and Raven's colored progressive matrices. In addition, a pre- and post-treatment eyetracking-while-listening experiment will be conducted to investigate morphosyntactic processing in Turkish and to examine whether the two brain stimulation interventions differentially affect online (dynamic, time-dependent) measures of morphosyntactic processing. The eyetracking paradigm will request the participants to listen to Turkish sentences varying in morphosyntactic complexity (canonical versus noncanonical sentences) and to look at the picture (out of two pictures presented on the screen) corresponding to the sentence they are listening to.
- Conditions
- Aphasia
- Being tested
- rTMS over right frontal target, rTMS over right temporal target
- Keywords
- Repetitive transcranial magnetic stimulation, Aphasia
- Medical subject headings
- Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS over right frontal targetDevice
Low frequency (1 Hz) rTMS over right inferior frontal gyrus
rTMS over right temporal targetDevice
Low frequency (1 Hz) rTMS over right posterior superior temporal gyrus
| Study group | Role | What they receive |
|---|---|---|
| Right frontal 1 Hz rTMS | Experimental | Low-frequency (1 Hz) inhibitory rTMS will be administered to right inferior frontal gyrus with the following parameters:
Frequency: 1 Hz Stimulation site: Right IFG (as determined using EEG 10-20 system) Intensity: 100% of motor threshold Dosage: 20 minutes per day Duration: 10 days over 2 weeks (no stimulation during weekends) Receives: Device: rTMS over right frontal target |
| Right temporal 1 Hz rTMS | Active comparator | Low-frequency (1 Hz) inhibitory rTMS will be administered to right posterior superior temporal gyrus with the following parameters:
Frequency: 1 Hz Stimulation site: Right posterior superior temporal gyrus (as determined using EEG 10-20 system) Intensity: 100% of motor threshold Dosage: 20 minutes per day Duration: 10 days over 2 weeks (no stimulation during weekends) Receives: Device: rTMS over right temporal target |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish Aphasia Language Assessment Test Scores Time 1 (pre-treatment)
Baseline scores obtained from the Turkish Aphasia Language Assessment Test (ADD) Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Measured: Immediately before the intervention (Day 0)
Turkish Aphasia Language Assessment Test Scores Time 2 (during treatment)
Scores obtained from the Turkish Aphasia Language Assessment Test (ADD) at the end of the first week of treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Measured: At the end of the first week of intervention (Day 5)
Turkish Aphasia Language Assessment Test Scores Time 3 (post-treatment short-term)
Post-treatment scores obtained from the Turkish Aphasia Language Assessment Test (ADD) at the end of the treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Measured: Immediately after the intervention (Day 10)
Turkish Aphasia Language Assessment Test Scores Time 4 (post-treatment medium-term)
Post-treatment scores obtained from the Turkish Aphasia Language Assessment Test (ADD) one month after the end of the treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Measured: 1 month after the intervention
Turkish Aphasia Language Assessment Test Scores Time 5 (post-treatment long-term)
Post-treatment scores obtained from the Turkish Aphasia Language Assessment Test (ADD) six months after the end of the treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Measured: 6 months after the intervention
Picture Naming Scores Time 1 (pre-treatment)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Measured: Immediately before the intervention (Day 0)
Picture Naming Scores Time 2 (during treatment)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Measured: At the end of the first week of intervention (Day 5)
Picture Naming Scores Time 3 (post-treatment short-term)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Measured: Immediately after the intervention (Day 10)
Picture Naming Scores Time 4 (post-treatment medium-term)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Measured: 1 month after the intervention
Picture Naming Scores Time 5 (post-treatment long-term)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Measured: 6 months after the intervention
Eye movements Time 1 (pre-treatment)
An eyetracking-while-listening paradigm will be used to determine proportions of dwell time on the correct picture (out of two alternatives) corresponding to auditorily presented Turkish sentences varying in morphosyntactic complexity.
Measured: Immediately before the intervention (Day 0)
Eye movements Time 2 (post-treatment)
An eyetracking-while-listening paradigm will be used to determine proportions of dwell time on the correct picture (out of two alternatives) corresponding to auditorily presented Turkish sentences varying in morphosyntactic complexity.
Measured: Immediately after the intervention (Day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start18 Jul 2022
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Model description
- The two groups receive one of the two treatments: right frontal versus right temporal stimulation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Talat Bulut, Medipol University
- Investigators
- Talat Bulut, Ph.D., Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450341
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2022
- First submitted
- 30 Jun 2022
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' anonymized data will be shared with the scientific community as part of open science practices. IPD refer to the data collected from the participants (language and cognitive test scores; i.e., ADD and naming performance, number/percentage of correct answers, raw and scaled scores, short-term memory scores (digit span), nonverbal intelligence scores (Raven's colored progressive matrices). IPD also include eye movements data obtained in the eyetracking experiment; i.e., proportions of dwell time on the target picture.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Low-frequency Repetitive Transcranial Magnetic Stimulation on Rehabilitation of Aphasia
- ClinicalTrials.gov ID
- NCT05450341
- Acronym / sponsor ID
- 1
- Conditions
- Aphasia
- Keywords
- Repetitive transcranial magnetic stimulation, Aphasia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 8 Jul 2022 (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.
In a randomized controlled trial, efficacy of low-frequency, inhibitory rTMS will be examined in rehabilitation of acquired aphasia. Two cortical sites will be targeted: Right-hemispheric homologues of Broca's and Wernicke's areas.
In addition to cognitive screening prior to onset of rTMS, language assessments will be conducted before, during and after the intervention. An eyetracking-while-listening experiment will also be conducted before and after the intervention to investigate morphosyntactic processing.
Detailed description
Efficacy of low-frequency (1hz), inhibitory rTMS will be examined in rehabilitation of acquired aphasia. Two cortical sites will be targeted: Right-hemispheric homologues of Broca's and Wernicke's areas. In other words, right frontal and right temporal sites will be targeted.
In addition to cognitive screening prior to onset of rTMS, language assessments will be conducted before, during and after the intervention. The language assessment will be conducted using the Turkish Aphasia Language Assessment Test (ADD) and sets of pictures used to assess naming performance. ADD will be carried out before and after the intervention. Six picture sets will be used, one at baseline, four on different days during the intervention, and the last one immediately after the last day of the intervention. Cognitive screening will be conducted at baseline using the digit span test and Raven's colored progressive matrices. In addition, a pre- and post-treatment eyetracking-while-listening experiment will be conducted to investigate morphosyntactic processing in Turkish and to examine whether the two brain stimulation interventions differentially affect online (dynamic, time-dependent) measures of morphosyntactic processing. The eyetracking paradigm will request the participants to listen to Turkish sentences varying in morphosyntactic complexity (canonical versus noncanonical sentences) and to look at the picture (out of two pictures presented on the screen) corresponding to the sentence they are listening to.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The two groups receive one of the two treatments: right frontal versus right temporal stimulation.
| Arm | Type | Receives |
|---|---|---|
| Right frontal 1 Hz rTMS | Experimental | Device: rTMS over right frontal targetLow-frequency (1 Hz) inhibitory rTMS will be administered to right inferior frontal gyrus with the following parameters: Frequency: 1 Hz Stimulation site: Right IFG (as determined using EEG 10-20 system) Intensity: 100% of motor threshold Dosage: 20 minutes per day Duration: 10 days over 2 weeks (no stimulation during weekends) |
| Right temporal 1 Hz rTMS | Active comparator | Device: rTMS over right temporal targetLow-frequency (1 Hz) inhibitory rTMS will be administered to right posterior superior temporal gyrus with the following parameters: Frequency: 1 Hz Stimulation site: Right posterior superior temporal gyrus (as determined using EEG 10-20 system) Intensity: 100% of motor threshold Dosage: 20 minutes per day Duration: 10 days over 2 weeks (no stimulation during weekends) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Right-handedness,
- Normal or corrected-to-normal vision and hearing,
- Aphasia following cerebrovascular accident,
- Cerebrovascular accident at least 6 months prior to enrolment in the study,
- Satisfying current TMS safety guidelines (Rossi et al. 2009, 2021), which are:
Key exclusion criteria (8 listed)
- Left-handedness, ambidexterity,
- Impaired and uncorrected vision or hearing,
- No aphasia symptoms following cerebrovascular accident,
- Time since cerebrovascular accident less than 6 months,
- Violating current TMS safety guidelines (Rossi et al. 2009, 2021). In other words:
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 |
|---|---|---|
| rTMS over right frontal targetLow frequency (1 Hz) rTMS over right inferior frontal gyrus | Device | Right frontal 1 Hz rTMS |
| rTMS over right temporal targetLow frequency (1 Hz) rTMS over right posterior superior temporal gyrus | Device | Right temporal 1 Hz rTMS |
Primary outcome
Turkish Aphasia Language Assessment Test Scores Time 1 (pre-treatment)
Time frame: Immediately before the intervention (Day 0)
Baseline scores obtained from the Turkish Aphasia Language Assessment Test (ADD) Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Turkish Aphasia Language Assessment Test Scores Time 2 (during treatment)
Time frame: At the end of the first week of intervention (Day 5)
Scores obtained from the Turkish Aphasia Language Assessment Test (ADD) at the end of the first week of treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Turkish Aphasia Language Assessment Test Scores Time 3 (post-treatment short-term)
Time frame: Immediately after the intervention (Day 10)
Post-treatment scores obtained from the Turkish Aphasia Language Assessment Test (ADD) at the end of the treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Turkish Aphasia Language Assessment Test Scores Time 4 (post-treatment medium-term)
Time frame: 1 month after the intervention
Post-treatment scores obtained from the Turkish Aphasia Language Assessment Test (ADD) one month after the end of the treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Turkish Aphasia Language Assessment Test Scores Time 5 (post-treatment long-term)
Time frame: 6 months after the intervention
Post-treatment scores obtained from the Turkish Aphasia Language Assessment Test (ADD) six months after the end of the treatment Minimum score: 0 points Maximum score: 292 points Higher scores indicate a better outcome
Picture Naming Scores Time 1 (pre-treatment)
Time frame: Immediately before the intervention (Day 0)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Picture Naming Scores Time 2 (during treatment)
Time frame: At the end of the first week of intervention (Day 5)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Picture Naming Scores Time 3 (post-treatment short-term)
Time frame: Immediately after the intervention (Day 10)
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Picture Naming Scores Time 4 (post-treatment medium-term)
Time frame: 1 month after the intervention
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Picture Naming Scores Time 5 (post-treatment long-term)
Time frame: 6 months after the intervention
Picture naming performance (number of accurately named pictures \& naming latency for correctly named pictures) There are 20 pictures in total, of which half are objects and half actions. Minimum score: 0 points Maximum score: 20 points Higher scores indicate a better outcome
Eye movements Time 1 (pre-treatment)
Time frame: Immediately before the intervention (Day 0)
An eyetracking-while-listening paradigm will be used to determine proportions of dwell time on the correct picture (out of two alternatives) corresponding to auditorily presented Turkish sentences varying in morphosyntactic complexity.
Eye movements Time 2 (post-treatment)
Time frame: Immediately after the intervention (Day 10)
An eyetracking-while-listening paradigm will be used to determine proportions of dwell time on the correct picture (out of two alternatives) corresponding to auditorily presented Turkish sentences varying in morphosyntactic complexity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- Individual participant dataSharing planned: Yes. Participants' anonymized data will be shared with the scientific community as part of open science practices. IPD refer to the data collected from the participants (language and cognitive test scores; i.e., ADD and naming performance, number/percentage of correct answers, raw and scaled scores, short-term memory scores (digit span), nonverbal intelligence scores (Raven's colored progressive matrices). IPD also include eye movements data obtained in the eyetracking experiment; i.e., proportions of dwell time on the target picture.
Related trials for Aphasia
Not yet recruiting
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Expressive Aphasia, Aphasia Following Cerebral Infarction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
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Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Talat Bulut, Ph.D. principal investigator
Medipol 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 rTMS over right frontal target and rTMS over right temporal target in people with Aphasia, run by Medipol 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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Talat Bulut, Ph.D. (+905313327754, tbulut@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish Aphasia Language Assessment Test Scores Time 1 (pre-treatment) (time frame: Immediately before the intervention (Day 0)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Aug 2022.