Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Post-stroke Anomic Aphasia

Sponsor
Ege University (Other)
Overall Status
Completed
CT.gov ID
NCT04625790
Collaborator
(none)
25
1
2
12
2.1

Study Details

Study Description

Brief Summary

The aim of the study is to observe the effects of speech therapy and transcranial magnetic stimulation therapy in patients who develop anomic aphasia after stroke. Patients meeting the inclusion criteria will be randomly divided into groups. In the repetitive transcranial magnetic stimulation (rTMS) treatment group, a total of 10 sessions, 1 session per day, will be applied to the right inferior frontal gyrus area with a frequency of 1 Hz for 20 minutes. The control group patients will be given speech therapy in the same way, but no active magnetic stimulation will be given in rTMS sessions (sham application). Speech therapy will be given to each patient by the same physiotherapist, and the treatment will last a total of 10 days, 60 minutes a day. Minimental test (MMT), Ege aphasia test, aphasia quality of life scale (SAQOL-39) will be filled in to the patients before and after the treatment.

Condition or Disease Intervention/Treatment Phase
  • Device: Repetitive transcranial magnetic stimulation
  • Other: Speech therapy
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Participants will not know their groups, and the transcranial magnetic stimulation applications will be done in similar conditions, except for no stimulation with the position of the coil. The masking will also be done for the care provider, investigator and the outcomes assessor, as the evaluator and the researcher who provides the randomization will be different, and the data recording will be kept without implying the groups.
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Patients With Post-stroke Anomic Aphasia
Actual Study Start Date :
Nov 6, 2020
Actual Primary Completion Date :
Nov 6, 2021
Actual Study Completion Date :
Nov 6, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study group

After randomization, this group will take 10 sessions of 1-Hz low frequency rTMS will be applied to the inferior frontal gyrus of the right frontal lobe for 20 minutes during the stroke treatment process before 10 days of speech therapy. Speech therapy will be given to each patient by the same therapist who is qualified in this field, and the treatment will last 10 days, 60 minutes a day.

Device: Repetitive transcranial magnetic stimulation
Transcranial Magnetic Stimulation(TMS) has been used for diagnostic and therapeutic purposes in the treatment of many neurological and psychiatric diseases such as stroke, multiple sclerosis, myelopathy, amyotrophic lateral sclerosis, movement disorders, epilepsy, and depression. It is a way to stimulate the targeted areas in the cerebral cortex without invasive methods. The application of TMS in the aphasia usually consists of repetitive stimulations, in order to activate or deactivate the target area. In this study, 10 sessions of 1-Hz low frequency rTMS for 20 minutes will be applied to the inferior frontal gyrus of the right frontal lobe.

Other: Speech therapy
Speech therapy will be given to each patient by the same therapist, and the treatment will last 10 days, 60 minutes a day. It will consist of exercises to improve the articulation and comprehension.

Placebo Comparator: Control group

This group will take 10 sessions of sham rTMS for 20 minutes during the stroke treatment process before 10 days of speech therapy. The sham therapy will consist of positioning the coil on the cranium at the same spot, but without a magnetic stimulation, only with the device open and the sounds will be audible. Speech therapy will be given to each patient by the same therapist who is qualified in this field, and the treatment will last 10 days, 60 minutes a day.

Other: Speech therapy
Speech therapy will be given to each patient by the same therapist, and the treatment will last 10 days, 60 minutes a day. It will consist of exercises to improve the articulation and comprehension.

Outcome Measures

Primary Outcome Measures

  1. Ege Aphasia Test [2 weeks]

    Ege aphasia test (EAT): The test battery acquired in 2011 and used in the study consists of 8 subtests: speech style and characteristics, apraxia assessment, auditory / verbal comprehension, repetition, naming, visual understanding / reading, drawing figures / writing / sentences, mathematics. Although there is variability in the scoring of the EAT according to the subtests, generally 0 points are given to correct answers, and 1, 2 or more points are given to repeated and incorrect answers. The validity and reliability of the test was shown in 2013 by Atamaz et al.

Secondary Outcome Measures

  1. Stroke and Aphasia Quality of Life Scale ( SAQOL-39 ) [2 weeks]

    Stroke and Aphasia Quality of Life Scale(SAQOL-39): This scale consists of 4 subscales (physical, communication, psychosocial and energy) and 39 items. Its validity, reliability and usability have been proven in individuals who develop aphasia after stroke. The overall score ranges from 1 to 5, with higher scores being associated with better outcomes.

  2. Mini Mental Test(MMT) [2 weeks]

    Mini mental test includes 5 domains: Orientation, recording memory, attention and calculation, recall and language. It consists of 11 items and is evaluated over the total score of 30. Traditionally, scores between 24 and 30 are considered normal. A score below 24 indicates cognitive impairment.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Stroke diagnosed with cranial MR examination causing unilateral hemiplegia

  • Post-stroke patients with anomic aphasia

  • 40-70 years

  • Being able to read the basic instructions

  • Medically and neurologically stable patients

Exclusion Criteria:
  • Clinical condition that will constitute a contraindication to TMS (metallic implant, Cardiac pacemaker, pregnancy, breastfeeding, epilepsy, head trauma...)

  • Having previously had TMS treatment

  • Presence of Life-threatening disease and/or active systemic disease (chronic disease, malignancy ...)

  • Alcohol or drug addiction

  • Presence of neurodegenerative or psychiatric disorders

  • Pregnancy or breastfeeding status

  • Severe cognitive impairment

  • Having a history of previous epilepsy

  • Visual and auditory impairment

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ege University Faculty of Medicine İzmir Turkey 35100

Sponsors and Collaborators

  • Ege University

Investigators

  • Principal Investigator: Kadir Kara, MD, Ege University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kadir Kara M.D, Physician, Researcher, Ege University
ClinicalTrials.gov Identifier:
NCT04625790
Other Study ID Numbers:
  • Anomia-rTMS
First Posted:
Nov 12, 2020
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022