Efficacy of Low-frequency rTMS in Aphasia

Sponsor
Medipol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05450341
Collaborator
(none)
20
1
2
7.4
2.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: rTMS over right frontal target
  • Device: rTMS over right temporal target
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The two groups receive one of the two treatments: right frontal versus right temporal stimulation.The two groups receive one of the two treatments: right frontal versus right temporal stimulation.
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
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.
Primary Purpose:
Treatment
Official Title:
Efficacy of Low-frequency Repetitive Transcranial Magnetic Stimulation on Rehabilitation of Aphasia
Anticipated Study Start Date :
Jul 18, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Turkish Aphasia Language Assessment Test Scores Time 1 (pre-treatment) [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

  2. Turkish Aphasia Language Assessment Test Scores Time 2 (during treatment) [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

  3. Turkish Aphasia Language Assessment Test Scores Time 3 (post-treatment short-term) [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

  4. Turkish Aphasia Language Assessment Test Scores Time 4 (post-treatment medium-term) [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

  5. Turkish Aphasia Language Assessment Test Scores Time 5 (post-treatment long-term) [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

  6. Picture Naming Scores Time 1 (pre-treatment) [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

  7. Picture Naming Scores Time 2 (during treatment) [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

  8. Picture Naming Scores Time 3 (post-treatment short-term) [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

  9. Picture Naming Scores Time 4 (post-treatment medium-term) [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

  10. Picture Naming Scores Time 5 (post-treatment long-term) [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

  11. Eye movements Time 1 (pre-treatment) [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.

  12. Eye movements Time 2 (post-treatment) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 İstanbul Medipol University, Speech, Language and Swallowing Therapy and Research Center (MEDKOM) Istanbul Turkey 34815

Sponsors and Collaborators

  • Medipol University

Investigators

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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Talat Bulut, Assist. Prof. Dr., Medipol University
ClinicalTrials.gov Identifier:
NCT05450341
Other Study ID Numbers:
  • 1
First Posted:
Jul 8, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Talat Bulut, Assist. Prof. Dr., Medipol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022