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Clinical Trials/NCT04625790
NCT04625790
Completed
N/A

The Effectiveness of Speech Therapy and Repetitive Transcranial Magnetic Stimulation Therapy in Patients With Post-stroke Anomic Aphasia

Ege University1 site in 1 country25 target enrollmentNovember 6, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aphasia
Sponsor
Ege University
Enrollment
25
Locations
1
Primary Endpoint
Ege Aphasia Test
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 6, 2020
End Date
November 6, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kadir Kara M.D

Physician, Researcher

Ege University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Ege Aphasia Test

Time Frame: 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 Outcomes

  • Stroke and Aphasia Quality of Life Scale ( SAQOL-39 )(2 weeks)
  • Mini Mental Test(MMT)(2 weeks)

Study Sites (1)

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