Effects of Repetitive Transcranial Magnetic Stimulation Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- BNT (Boston naming test)
Study Overview
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 Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18-80 yrs old
- •Right-handed
- •Radiologically confirmed left hemisphere stroke
- •Fluent in Korean
- •First ever stroke
- •More than 1 year from stroke onset
- •Non-fluent (motor-dominant) aphasia
- •Written informed consent
Exclusion Criteria
- •Previous medical histories of stroke, cerebral vascular operation, seizure
- •Patients with traumatic brain injury
- •Unable to perform the language task
- •Severe cognitive impairment (MMSE less than 16)
- •Skin lesion in the stimulation site of scalp
- •Metal implants in the body (cardiac pacemaker or aneurysm clip)
- •Pregnancy, Breastfeeding
Outcomes
Primary Outcomes
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
Secondary Outcomes
- WAB (Western aphasia battery)(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))
- Laterality index (LI)(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))
Investigators
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital