Clinical Trial: Effects of rTMS Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia

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

Official Title: Effects of Repetitive Transcranial Magnetic Stimulation Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia: A Pilot Study

Brief Summary: The aim of this study is to assess the safety and clinical efficacy of high or low-frequency repetitive transcranial magnetic stimulation based on brain activation with functional near infrared spectroscopy in poststroke nonfluent aphasia patients.

Detailed Summary:

In poststsroke aphasia rehabilitation, repetitive transcranial stimulation (rTMS) studies aimed to reinforce the activity of the brain regions in the left hemisphere. This goal can be achieved by using an excitatory protocol to reactivate the perilesional area or inhibitory protocol to reduce activities in the contralesional area. However, most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.

In the present pilot study, investigators will perform functional near-infrared spectroscopy (fNIRS) prior to rTMS treatment for selection of the most appropriate application of stimulation. Stimulation site and protocol (high frequency or low frequency rTMS) will be determined by activation pattern from the fNIRS findings with language task in individual patients.


Sponsor: Seoul National University Bundang Hospital

Current Primary Outcome: BNT (Boston naming test) [ Time Frame: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy) ]

speech evaluation tool for measuring the confrontational word retrieval function


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • WAB (Western aphasia battery) [ Time Frame: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy) ]
    speech evaluation tool for screening the presence, degree, and type of aphaisa
  • Laterality index (LI) [ Time Frame: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy) ]
    From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemisphereic Hbo values, respectively)


Original Secondary Outcome: Same as current

Information By: Seoul National University Bundang Hospital

Dates:
Date Received: September 13, 2015
Date Started: October 2015
Date Completion: August 2017
Last Updated: January 31, 2017
Last Verified: January 2017