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

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.
* Describe the impact of language behavior on the quality of life of patients treated with placebo and active EMT, assessed by the EuroQol test.

METHODOLOGY A placebo double blind controlled and randomize trial, to evaluate the efficacy of low frequency EMT-r in language recovery in 100 patients with first ischemic stroke event among the first 4-8 months postinfarction and non-fluent aphasia. The patient will agree and will sign the informed consent, in order to application aphasia diagnosis Boston test, Edinburgh test, Barthel scale, Zung anxiety and depression test, and EuroQol scale, Neuropsi. Subsequently the subjects will be randomizate to any of two arms of the study. A week before the start of the stimulation sessions, the following tests will be applied to assess language production: Boston Test and Verbal Fluency (FAS). Each patient will have a daily session EMT-r low-frequency active or inactive coil with a biphasic stimulator pulses applied for ten days in two weeks on the triangular area - homologous to injury Lower Front Gyrus (LFG), (right brain hemisphere). Complete the treatment schedule of two weeks, the language production will be evaluate again, and also scales as Barthel an Rankin-m, Zung anxiety and depression and EuroQol. This monitoring will be achieved in five stages: after one week, one month, 4 months, 8 months and 12 months post-stimulation, with the intention of determining the duration and effectiveness effects in language production of the EMT-r.

Conditions

• Aphasia, Broca

Interventions

DEVICE

Transcranial Magnetic Stimulation (TMS-r)

10 sessions, each session of EMT-r will be low frequency (1 Hz for 20 minutes and a total of 1200 pulses) using a biphasic pulse stimulator, with active coil (coil-shaped focal or inactive coil "placebo" for 2 weeks from Monday to Friday, target: triangular portion - homologous to injury Inferior front Gyrus (GFI).

DEVICE

Placebo Transcranial Magnetic Stimulation

10 sesions of Non- active coil, that will simulate the sound of the TMS, holding the coil on the scalp at an angle of 45 degrees in the selected area

Sponsors & Collaborators

• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

  collaborator OTHER_GOV

• Fundación Cardiovascular de Colombia

  lead OTHER

Principal Investigators

• Federico A Silva, MD,MSc · Fundacion Cardiovascular de Colombia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-31

Primary Completion

2017-08-31

Completion

2017-12-31

Countries

• Colombia

Study Locations