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

Seoul National University

Status: Enrolling

Conditions: Stroke; Aphasia

Treatments: Device: MagPro magnetic stimulator (LF rTMS); Device: MagPro magnetic stimulator (sham); Device: MagPro magnetic stimulator (HF rTMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT02591719

B-1507-308-006/P2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups

MagPro magnetic stimulator (HF rTMS)

Experimental group

Description:

Most activated area from fNIRS with language task: Perilesional Broca's area

Treatment:

Device: MagPro magnetic stimulator (HF rTMS)

MagPro magnetic stimulator (sham)

Sham Comparator group

Description:

Most activated area from fNIRS with language task: Perilesional Broca's area

Treatment:

Device: MagPro magnetic stimulator (sham)

MagPro magnetic stimulator (LF rTMS)

Active Comparator group

Description:

Most activated area from fNIRS with language task: Contralesional homologs of Broca's area

Treatment:

Device: MagPro magnetic stimulator (LF rTMS)