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NCT Number: NCT04625790

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

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.

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Key information

Conditions

Aphasia Anomia Aphasia, Anomic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Stroke Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University Faculty of Medicine

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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.

Speech therapy

Other

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.

Primary outcomes

  1. 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

  1. Stroke and Aphasia Quality of Life Scale ( SAQOL-39 )

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2020
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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