Clinical Trial: Effects of MTS-r on Speech Production in Non-fluent Aphasia Post-ischemic Stroke Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effects of Repetitive Magnetic Transcranial Stimulation of Low Frequency on Speech Production in Patients With Non-fluent Aphasia Post-ischemic Stroke

Brief Summary:

Aphasia is one of the most disabling complications in language production in patients with left hemisphere stroke. About 19% of patients who experience aphasia may have a spontaneously recovery after several weeks or months. Some studies have reported that repetitive low frequency Transcranial Magnetic Stimulation (TMS-r) in patients with ischemic stroke generates left modulation of cortical excitability by facilitating and promoting functional reorganization and recovery of language production. In spite of this, most of the studies in patients with post-stroke aphasia, are small cases series without controls that correspond to a descriptive design and does not perform long-term follow up. Currently the population is heterogeneous respect to etiology, type of stroke and aphasia severity; also several authors have concluded that the exact location of the site, would be possible through the neuronavigation technique, to obtain better results.

OVERALL OBJECTIVE Determine the efficacy of repetitive low-frequency TMS on oral language recovery in post-ischemic stroke patients with non-fluent aphasia

ESPECIFIC OBJETIVES

  • Estimate the effect of repetitiveTMS treatment on right Lowe Frontal Gyrus (GFI), in the evolution of the neuropsychological language test results in patients with non-fluent aphasia, compared to placebo.
  • Describe the behavior of depression and anxiety levels in both treatment groups (active and placebo), through Zung anxiety and depression test, to establish their correlation with production testing language.
  • Evaluate the effect of repetitiveTMS technique compared to placebo, on the overall functionality of the subject through Barthel scale.
  • Some studies have reported that low frequency repetitive Transcranial Magnetic Stimulation in patients with ischemic stroke generates left modulation of cortical excitability by facilitating, and promoting functional reorganization and facilitate the language production.

    Stroke is a major public health problem, one-third of patients do not survive the first year after the vascular event, cause of severe disability and also is the third leading cause of death worldwide. Two-thirds of the survivors have neurologic deficits including aphasia (19%) generating functional disability, compromise on their daily living activities, and impact on the quality of life (93% of patients with aphasia after stroke compared with 50% of those survive without aphasia). Aphasia is an additional risk factor for depression (prevalence 5-63%), and also interfering with the functional and cognitive recovery, increasing the risk of mortality.

    Generally the treatment of aphasia is based on speech therapy and drug therapy oriented comorbidities such as depression or anxiety. However, it has studied different interventions in an effort to improve the speech recovery of aphasia, as Transcranial Magnetic Stimulation (TMS), which facilitates recovery by stimulating contralesional and lesional regions. Most studies have been based on the transcallosal disinhibition theory, which consist on blocking homotopic regions through low frequency stimulation in the right posterior GFI (triangular portion) to produce a GFI disinhibition from right to left and facilitate neuroplasticity brain process.

    EMT technique is based on the principle of electromagnetic induction, proposed by Michael Faraday (1831), in which posits that magnetic field depends on the stimulation time, generating an electric field that eventually
    Sponsor: Fundación Cardiovascular de Colombia

    Current Primary Outcome: Boston-test for aphasia diagnosis [ Time Frame: 3 years ]

    Evaluates the different domains of language to determine the severity degree of aphasia. Applicable in patients from 16 years old and its duration is approximately 90 minutes. This test has various scales such as intonation, phrase extension, language articulation, grammar, paraphasias, repetition, word search and listening


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Zung- Depression and anxiety [ Time Frame: 3 years ]
      Evaluates the level of depression in patients with a depressive disorder. This scale is conformed by 20 items assessing 4 common characteristics of depression: the dominant effect, physiological equivalents, other disturbances, and psychomotor activities. Each question is rated on a scale of 1-4 categorized in (1 = few times, 2 = some times, 3 = a good part of the time and 4 = most of the time). The score range is 20-80. Where scores between 5-49 equivalent to a normal range; 50-59 slightly depressed; 60-69 moderately depressed and severely depressed 70 or more [56].
    • Barthel-Scale [ Time Frame: 3 Years ]
      Instrument for measuring the basic activities of daily living (ADL), used especially in patients with acute cerebrovascular disease. Rate the ability of a person to perform in a dependent or independent 10 ABVD, assigning a score (0, 5, 10,15) depending on the time spent on its implementation and the need for help to carry it out. The final score ranges from 0 to 100 where the values are equivalent to between 95-100 independent.; 91-99 mild dependent; 61-90: moderately dependent; 21-60; dependent grave; 0-20 totally dependent [57].
    • Scale quality of life (EuroQol, EQ-5D) [ Time Frame: 3 Years ]
      Evaluate two aspects:The first is the description of the state of health in five dimensions (mobility, self-care, usual activities, pain / discomfort and anxiety / depression), each of which is defined with three levels of severity, as measured by a Likert scale (no problems, some problems and many problems or inability to activity) type. The state of health of the individual is a combination of severity in each five dimensions, expressed by a numerical data. On the other hand, in the second part of the questionnaire the subject must score on a visual millimeter analogue scale his auto perception condition health at the time, considering the ends of the scale as the worst health status (0) and better health [61, 62]
    • Edinburgh-Scale [ Time Frame: 3 Years ]
      Is used to assess handedness in daily activities. This inventory can be scored through observation or patient self-report. Interpretation: scores below -40 correspond to left dominance; scores between -40 and +40 is ambidextrous and above +40 right dominance [55].


    Original Secondary Outcome: Same as current

    Information By: Fundación Cardiovascular de Colombia

    Dates:
    Date Received: July 9, 2014
    Date Started: August 2014
    Date Completion: December 2017
    Last Updated: September 12, 2014
    Last Verified: September 2014