Efficacy of Low-frequency rTMS in Aphasia

NCT ID: NCT05450341

Last Updated: 2022-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2023-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

rTMS over right frontal target

Intervention Type: DEVICE

Low frequency (1 Hz) rTMS over right inferior frontal gyrus

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)

Group Type: ACTIVE_COMPARATOR

rTMS over right temporal target

Intervention Type: DEVICE

Low frequency (1 Hz) rTMS over right posterior superior temporal gyrus

Interventions

rTMS over right frontal target

Low frequency (1 Hz) rTMS over right inferior frontal gyrus

Intervention Type: DEVICE

rTMS over right temporal target

Low frequency (1 Hz) rTMS over right posterior superior temporal gyrus

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Talat Bulut

Assist. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Talat Bulut, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

İstanbul Medipol University, Speech, Language and Swallowing Therapy and Research Center (MEDKOM)

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Talat Bulut, Ph.D.

Role: CONTACT

tbulut@medipol.edu.tr

+905313327754

MEDKOM

Role: CONTACT

tbulut@medipol.edu.tr

+90 444 85 44 ext. 1890

Facility Contacts

Talat Bulut, PhD

Role: primary

tbulut@medipol.edu.tr

444 85 44 ext. 1890

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id