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NCT Number: NCT02556385

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

The aim of this study is to assess the safety and clinical efficacy of high or low-frequency repetitive transcranial magnetic stimulation based on brain activation with functional near infrared spectroscopy in 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

In poststsroke aphasia rehabilitation, repetitive transcranial stimulation (rTMS) studies aimed to reinforce the activity of the brain regions in the left hemisphere. This goal can be achieved by using an excitatory protocol to reactivate the perilesional area or inhibitory protocol to reduce activities in the contralesional area. However, most conventional rTMS studies employed an inhibitory low frequency protocol for the contralesional homologs of Broca's area.

In the present pilot study, investigators will perform functional near-infrared spectroscopy (fNIRS) prior to rTMS treatment for selection of the most appropriate application of stimulation. Stimulation site and protocol (high frequency or low frequency rTMS) will be determined by activation pattern from the fNIRS findings with language task in individual patients.

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
  • Fluent in Korean
  • First ever stroke
  • More than 1 year from stroke onset
  • 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

High frequency rTMS

Device

Most activated area from fNIRS findings: Perileisional Broca's area, 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

Low frequency rTMS

Device

Most activated area from fNIRS findings: Contralesional homologs of Broca's area, 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

Primary outcomes

  1. BNT (Boston naming test)

    Time frame: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy)

    speech evaluation tool for measuring the confrontational word retrieval function

Secondary outcomes

  1. WAB (Western aphasia battery)

    Time frame: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy)

    speech evaluation tool for screening the presence, degree, and type of aphaisa

  2. Laterality index (LI)

    Time frame: Before rTMS(baseline), after the completion of 10 session of treatment (rTMS+speech therapy), 2 weeks later after the completion of 10 session of treatment (rTMS+speech therapy)

    From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemisphereic Hbo values, respectively)

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Effects of Repetitive Transcranial Magnetic Stimulation Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia: A Pilot Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 22, 2015
Registry last updated
Aug 31, 2022

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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