Effects of Repetitive Transcranial Magnetic Stimulation Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- BNT (Boston Naming Test)
Study Overview
Brief Summary
The aim of this study is to assess the safety and clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.
Detailed Description
Most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.
In the present randomized controlled trial, investigators will perform fNIRS prior to rTMS treatment to select the stimulation method. Stimulation site (perilesional or contralesional) and frequency (excitatory high or inhibitory low) will be determined by activation pattern from the fNIRS with language task in individual patients.
The patient who shows a dominant neural activity at perilesional Broca's area on fNIRS scanning will be randomly allocated into two groups: high frequency stimulation group and sham stimulation group. If a patient shows a dominant neural activity at contralesional homologs of Broca's area on fNIRS scanning, the patient will be allocated to a low frequency stimulation group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 within 6 months
- •Fluent in Korean
- •First ever stroke
- •Non-fluent (motor-dominant) aphasia
- •Written informed consent
Exclusion Criteria
- •Previous medical histories of stroke, cerebral vascular operation,
- •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
Arms & Interventions
MagPro magnetic stimulator (HF rTMS)
Most activated area from fNIRS with language task: Perilesional Broca's area
Intervention: MagPro magnetic stimulator (HF rTMS) (Device)
MagPro magnetic stimulator (sham)
Most activated area from fNIRS with language task: Perilesional Broca's area
Intervention: MagPro magnetic stimulator (sham) (Device)
MagPro magnetic stimulator (LF rTMS)
Most activated area from fNIRS with language task: Contralesional homologs of Broca's area
Intervention: MagPro magnetic stimulator (LF rTMS) (Device)
Outcomes
Primary Outcomes
BNT (Boston Naming Test)
Time Frame: up to 2 weeks
speech evaluation tool for measuring the confrontational word retrieval function
Secondary Outcomes
- LI (Laterality Index; From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemispheric HbO (oxyhemoglobin) or total Hb values, respectively)(up to 6 weeks)
- BNT (Boston Naming Test)(4 weeks)
- WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia)(up to 6 weeks)
Investigators
Nam-Jong Paik
Professor
Seoul National University Bundang Hospital