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

NCT ID: NCT02556385

Last Updated: 2022-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-08-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke Aphasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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High frequency rTMS

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

Group Type EXPERIMENTAL

High frequency rTMS

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

Low frequency rTMS

Intervention Type 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

Interventions

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High frequency rTMS

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

Intervention Type DEVICE

Low frequency rTMS

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nam-Jong Paik

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nam-Jong Paik, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea

Locations

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

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

Site Status

Countries

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South Korea

Other Identifiers

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B-1507-308-006

Identifier Type: -

Identifier Source: org_study_id

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