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

Not Applicable

Completed

• Conditions: Stroke; Aphasia
• Interventions: Device: High frequency rTMS; Device: Low frequency rTMS

• Registration Number: NCT02556385
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-09-13
• Study First Submitted QC: 2015-09-19
• Study First Posted: 2015-09-22
• Study Start: 2015-10
• Primary Completion: 2017-08-24
• Study Completion: 2017-08-24
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High frequency rTMS	High frequency rTMS	Most activated area from fNIRS with language task: Perileisional Broca's area
Low Frequency rTMS	Low frequency rTMS	Most activated area from fNIRS with language task: Contralesional homologs of Broca's area

Primary Outcome Measures

Name	Time	Method
BNT (Boston naming test)	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 Outcome Measures

Name	Time	Method
WAB (Western aphasia battery)	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
Laterality index (LI)	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)

Trial Locations

Locations (1)

Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Gyeonggi-do, Korea, Republic of