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NCT Number: NCT02591719

Effects of rTMS 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.

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Key information

Conditions

Stroke Aphasia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Language Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Speech Disorders Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital

Seongnam-si, Korea, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MagPro magnetic stimulator (HF rTMS)

Device

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

MagPro magnetic stimulator (sham)

Device

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

MagPro magnetic stimulator (LF rTMS)

Device

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

Primary outcomes

  1. BNT (Boston Naming Test)

    Time frame: up to 2 weeks

    speech evaluation tool for measuring the confrontational word retrieval function

Secondary outcomes

  1. 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'

  2. 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'

  3. BNT (Boston Naming Test)

    Time frame: 4 weeks

    speech evaluation tool for measuring the confrontational word retrieval function

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2015
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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