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

Not Applicable
Completed
Conditions
Stroke
Aphasia
Aphasia, Anomic
Interventions
Device: Repetitive transcranial magnetic stimulation
Other: Speech therapy
Registration Number
NCT04625790
Lead Sponsor
Ege University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
25
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Study groupRepetitive transcranial magnetic stimulationAfter 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.
Study groupSpeech therapyAfter 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.
Control groupSpeech therapyThis 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.
Primary Outcome Measures
NameTimeMethod
Ege Aphasia Test2 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
NameTimeMethod
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.

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.

Trial Locations

Locations (1)

Ege University Faculty of Medicine

🇹🇷

İzmir, Turkey

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