search
Back to results

Efficacy of Low-frequency rTMS in Aphasia

Primary Purpose

Aphasia

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
rTMS over right frontal target
rTMS over right temporal target
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Repetitive transcranial magnetic stimulation, Aphasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Right frontal 1 Hz rTMS

Right temporal 1 Hz rTMS

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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
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
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
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
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
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
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
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
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
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
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 30, 2022
Last Updated
August 27, 2022
Sponsor
Medipol University
search

1. Study Identification

Unique Protocol Identification Number
NCT05450341
Brief Title
Efficacy of Low-frequency rTMS in Aphasia
Official Title
Efficacy of Low-frequency Repetitive Transcranial Magnetic Stimulation on Rehabilitation of Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 18, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphasia
Keywords
Repetitive transcranial magnetic stimulation, Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The two groups receive one of the two treatments: right frontal versus right temporal stimulation.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Right frontal 1 Hz rTMS
Arm Type
Experimental
Arm Description
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)
Arm Title
Right temporal 1 Hz rTMS
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
rTMS over right frontal target
Intervention Description
Low frequency (1 Hz) rTMS over right inferior frontal gyrus
Intervention Type
Device
Intervention Name(s)
rTMS over right temporal target
Intervention Description
Low frequency (1 Hz) rTMS over right posterior superior temporal gyrus
Primary Outcome Measure Information:
Title
Turkish Aphasia Language Assessment Test Scores Time 1 (pre-treatment)
Description
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
Time Frame
Immediately before the intervention (Day 0)
Title
Turkish Aphasia Language Assessment Test Scores Time 2 (during treatment)
Description
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
Time Frame
At the end of the first week of intervention (Day 5)
Title
Turkish Aphasia Language Assessment Test Scores Time 3 (post-treatment short-term)
Description
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
Time Frame
Immediately after the intervention (Day 10)
Title
Turkish Aphasia Language Assessment Test Scores Time 4 (post-treatment medium-term)
Description
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
Time Frame
1 month after the intervention
Title
Turkish Aphasia Language Assessment Test Scores Time 5 (post-treatment long-term)
Description
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
Time Frame
6 months after the intervention
Title
Picture Naming Scores Time 1 (pre-treatment)
Description
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
Time Frame
Immediately before the intervention (Day 0)
Title
Picture Naming Scores Time 2 (during treatment)
Description
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
Time Frame
At the end of the first week of intervention (Day 5)
Title
Picture Naming Scores Time 3 (post-treatment short-term)
Description
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
Time Frame
Immediately after the intervention (Day 10)
Title
Picture Naming Scores Time 4 (post-treatment medium-term)
Description
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
Time Frame
1 month after the intervention
Title
Picture Naming Scores Time 5 (post-treatment long-term)
Description
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
Time Frame
6 months after the intervention
Title
Eye movements Time 1 (pre-treatment)
Description
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.
Time Frame
Immediately before the intervention (Day 0)
Title
Eye movements Time 2 (post-treatment)
Description
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.
Time Frame
Immediately after the intervention (Day 10)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Talat Bulut, Ph.D.
Phone
+905313327754
Email
tbulut@medipol.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
MEDKOM
Phone
+90 444 85 44
Ext
1890
Email
tbulut@medipol.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Talat Bulut, Ph.D.
Organizational Affiliation
Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
İstanbul Medipol University, Speech, Language and Swallowing Therapy and Research Center (MEDKOM)
City
Istanbul
ZIP/Postal Code
34815
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Talat Bulut, PhD
Phone
444 85 44
Ext
1890
Email
tbulut@medipol.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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)

Learn more about this trial

Efficacy of Low-frequency rTMS in Aphasia

We'll reach out to this number within 24 hrs