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

June 30, 2025 updated by: Nam-Jong Paik, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Korea, Gyeonggi-do
      • Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of, 463-707
        • Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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,
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MagPro magnetic stimulator (HF rTMS)
Most activated area from fNIRS with language task: Perilesional Broca's area
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
Other Names:
  • High frequency rTMS
Sham Comparator: MagPro magnetic stimulator (sham)
Most activated area from fNIRS with language task: Perilesional Broca's area
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
Other Names:
  • Sham stimulation
Active Comparator: MagPro magnetic stimulator (LF rTMS)
Most activated area from fNIRS with language task: Contralesional homologs of Broca's area
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

Other Names:
  • low frequency rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BNT (Boston Naming Test)
Time Frame: up to 2 weeks
speech evaluation tool for measuring the confrontational word retrieval function
up to 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia)
Time Frame: up to 6 weeks
Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'
up to 6 weeks
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)
Time Frame: up to 6 weeks
Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'
up to 6 weeks
BNT (Boston Naming Test)
Time Frame: 4 weeks
speech evaluation tool for measuring the confrontational word retrieval function
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Nam-Jong Paik, MD, PhD, Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimated)

October 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1507-308-006/P2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe