Efficacy of Low-frequency rTMS in Aphasia

Aphasia Clinical Trial

Official title:

Efficacy of Low-frequency Repetitive Transcranial Magnetic Stimulation on Rehabilitation of Aphasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05450341
• Other study ID #: 1
• Status: Recruiting
• Phase: N/A
• Start date: July 18, 2022
• Est. completion date: March 2023

Study information

• Verified date: August 2022
• Source: Medipol University
• Contact: Talat Bulut, Ph.D.
• Phone: +905313327754
• Email: tbulut[@]medipol.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aphasia

Intervention

Device:
• rTMS over right frontal target
Low frequency (1 Hz) rTMS over right inferior frontal gyrus
• rTMS over right temporal target
Low frequency (1 Hz) rTMS over right posterior superior temporal gyrus

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University, Speech, Language and Swallowing Therapy and Research Center (MEDKOM)	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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)
Primary	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)