Efficacy of Low-frequency rTMS in Aphasia

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.

Study Overview

• Status: Recruiting
• Conditions: Aphasia
• Intervention / Treatment: Device: rTMS over right frontal target; Device: rTMS over right temporal target

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Talat Bulut, Ph.D.; Phone Number: +905313327754; Email: tbulut@medipol.edu.tr
• Study Contact Backup: Name: MEDKOM; Phone Number: 1890 +90 444 85 44; Email: tbulut@medipol.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey, 34815
    • Recruiting
    • İstanbul Medipol University, Speech, Language and Swallowing Therapy and Research Center (MEDKOM)
    • Contact: Talat Bulut, PhD; Phone Number: 1890 444 85 44; Email: tbulut@medipol.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Right frontal 1 Hz rTMS; 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)	Device: rTMS over right frontal target; Low frequency (1 Hz) rTMS over right inferior frontal gyrus
Active Comparator: Right temporal 1 Hz rTMS; 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)	Device: rTMS over right temporal target; Low frequency (1 Hz) rTMS over right posterior superior temporal gyrus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Medipol University
• Investigators: Principal Investigator: Talat Bulut, Ph.D., Medipol University

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: June 30, 2022
• First Submitted That Met QC Criteria: July 6, 2022
• First Posted (Actual): July 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 27, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Aphasia; Repetitive transcranial magnetic stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Language Disorders; Communication Disorders; Speech Disorders; Aphasia
• Other Study ID Numbers: 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Upon publication of the results in a peer-reviewed journal. The data will be shared permanently.
• IPD Sharing 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)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No