Effects of MTS-r on Speech Production in Non-fluent Aphasia Post-ischemic Stroke Patients
Aphasia-ACV
Effects of Repetitive Magnetic Transcranial Stimulation of Low Frequency on Speech Production in Patients With Non-fluent Aphasia Post-ischemic Stroke
2 other identifiers
interventional
100
1 country
1
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.
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2014
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 16, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedSeptember 16, 2014
September 1, 2014
3 years
July 9, 2014
September 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Boston-test for aphasia diagnosis
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
3 years
Secondary Outcomes (4)
Zung- Depression and anxiety
3 years
Barthel-Scale
3 Years
Scale quality of life (EuroQol, EQ-5D)
3 Years
Edinburgh-Scale
3 Years
Other Outcomes (2)
Verbal Fluency Test (FAS)
3 Years
Brief Neuropsychological Battery (NEUROPSI)
3 Years
Study Arms (2)
Active Transcranial Magnetic Stimulation TMS- r
ACTIVE COMPARATORApplication of single stimulation pulses and regularly repeated ones, the frequency may be divided into high frequency EMT (\> 1 Hz), low frequency (\<1 Hz) This classification is based on physiological effects (stimulation or inhibition neuronal respectively). In this particular case, we will use low frequency \<1 Hz with repetitive pulses.
Placebo Transcranial Magnetic Stimulation
PLACEBO COMPARATORPlacebo coil that will simulate the sound of the pulses.
Interventions
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).
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
Eligibility Criteria
You may qualify if:
- Men and women age range from 50-70 years.
- School-level equal to or more than 5 years approved.
- Right hand dominance, determined through the Edinburgh Inventory (score above 40) .
- Ischemic stroke, at the territory of the left middle cerebral artery (MCA - Left).
- Aphasia diagnosis determined by the test for aphasia Boston.
- Patients who have previously received speech therapy
- Patients who gave their written informed consent
You may not qualify if:
- Pre-symptomatic diagnosis of stroke in more than one occasion.
- Diagnosis of neurodegenerative diseases such dementia and Parkinson's disease.
- Pre- Epilepsy diagnosis
- Diagnosis of Diabetes Mellitus Type I or II
- Diagnosis of liver disease or renal
- Diagnosis of Diseases-terminal to prevent tracking
- Diagnosis of psychiatric illnesses such as major depressive disorder (MDD) or other.
- Global cognitive impairment or previous diagnosis of dementia
- Visual or auditory deficit
- Patients with metal implants, cardiac pacemakers or drug infusion pumps.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fundacion Cardiovascular de Colombia
Bucaramanga, Santander Department, 0000, Colombia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Federico A Silva, MD,MSc
Fundacion Cardiovascular de Colombia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2014
First Posted
September 16, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2017
Study Completion
December 1, 2017
Last Updated
September 16, 2014
Record last verified: 2014-09