NCT02591719

Effects of rTMS Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia

Effects of Repetitive Transcranial Magnetic Stimulation Based on Neural Activation in Language Performance in Stroke Patients With Non-fluent Aphasia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Aphasia

Interventions

Type	Name	Description
DEVICE	MagPro magnetic stimulator (HF rTMS)	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
DEVICE	MagPro magnetic stimulator (sham)	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
DEVICE	MagPro magnetic stimulator (LF rTMS)	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

Timeline

• Start date: 2015-11-01
• Primary completion: 2023-10-20
• Completion: 2023-10-20
• First posted: 2015-10-29
• Last updated: 2025-07-03

Locations

1 site across 1 country: South Korea