Effects of rTMS Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Sham stimulation Device
    Intervention Desc: Most activated area from fNIRS findings: Perilesional Broca's area. Use the sham coil. High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
    ARM 1: Kind: Experimental
    Label: Sham stimulation
    Description: Most activated area from fNIRS with language task: Perilesional Broca's area
  • High frequency stimulation Device
    Other Names: MagPro magnetic stimulator (high frequency rTMS)
    Intervention Desc: Most activated area from fNIRS findings: Perilesional Broca's area. Use the true coil. High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
    ARM 1: Kind: Experimental
    Label: High frequency stimulation
    Description: Most activated area from fNIRS with language task: Perilesional Broca's area
  • Low frequency stimulation Device
    Other Names: MagPro magnetic stimulator (low frequency rTMS)
    Intervention Desc: Most activated area from fNIRS findings: Contralesional homologs of Broca's area. Use the true coil. Low frequency rTMS (1Hz), Number of total stimuli: 1200, Location: Contralesional homologs of Broca's area (Pars triangularis), Intensity: 90% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
    ARM 1: Kind: Experimental
    Label: Low frequency stimulation
    Description: Most activated area from fNIRS with language task: Contralesional homologs of Broca's area
  • MagPro magnetic stimulator (HF rTMS) Device
    Other Names: High frequency rTMS
    Intervention Desc: Most activated area from fNIRS findings: Perilesional Broca's area. Use the true coil. High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
    ARM 1: Kind: Experimental
    Label: MagPro magnetic stimulator (HF rTMS)
    Description: Most activated area from fNIRS with language task: Perilesional Broca's area
  • MagPro magnetic stimulator (sham) Device
    Other Names: Sham stimulation
    Intervention Desc: Most activated area from fNIRS findings: Perilesional Broca's area. Use the sham coil. High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
    ARM 1: Kind: Experimental
    Label: MagPro magnetic stimulator (sham)
    Description: Most activated area from fNIRS with language task: Perilesional Broca's area
  • MagPro magnetic stimulator (LF rTMS) Device
    Other Names: low frequency rTMS
    Intervention Desc: Most activated area from fNIRS findings: Contralesional homologs of Broca's area. Use the true coil. Low frequency rTMS (1Hz), Number of total stimuli: 1200, Location: Contralesional homologs of Broca's area (Pars triangularis), Intensity: 90% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
    ARM 1: Kind: Experimental
    Label: MagPro magnetic stimulator (LF rTMS)
    Description: Most activated area from fNIRS with language task: Contralesional homologs of Broca's area

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary BNT (Boston Naming Test; speech evaluation tool for measuring the confrontational word retrieval function) up to 2 weeks No
Secondary WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia) up to 6 weeks No
Secondary 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 No
Primary BNT (Boston Naming Test) up to 2 weeks

Sponsors