Efficacy of Low-frequency rTMS in Aphasia
Efficacy of Low-frequency Repetitive Transcranial Magnetic Stimulation on Rehabilitation of Aphasia
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
July 8, 2022
CompletedStudy Start
First participant enrolled
July 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2023
CompletedAugust 30, 2022
August 1, 2022
8 months
June 30, 2022
August 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
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
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
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
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
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
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
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
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
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
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
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.
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.
Immediately after the intervention (Day 10)
Study Arms (2)
Right frontal 1 Hz rTMS
EXPERIMENTALLow-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 COMPARATORLow-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)
Interventions
Low frequency (1 Hz) rTMS over right inferior frontal gyrus
Low frequency (1 Hz) rTMS over right posterior superior temporal gyrus
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
İstanbul Medipol University, Speech, Language and Swallowing Therapy and Research Center (MEDKOM)
Istanbul, 34815, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Talat Bulut, Ph.D.
Medipol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- The participant and the outcomes assessor (speech and language therapist conducting the assessment tests and the eyetracking experiment) will be blind as to which experiment group the participant belongs to. The investigator / clinician providing rTMS will not be blind to the experimental condition.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assist. Prof. Dr.
Study Record Dates
First Submitted
June 30, 2022
First Posted
July 8, 2022
Study Start
July 18, 2022
Primary Completion
March 1, 2023
Study Completion
March 1, 2023
Last Updated
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Upon publication of the results in a peer-reviewed journal. The data will be shared permanently.
- Access Criteria
- No access criteria required; a permanent link to the dataset will be made available so that the public can access the data (e.g., using https://osf.io/ or Mendeley Data)
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.