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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02556385
• Other study ID #: B-1507-308-006
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: August 24, 2017

Study information

• Verified date: August 2022
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 24, 2017
• Est. primary completion date: August 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Broca
• Stroke

Intervention

Device:
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital	Seongnam-si	Korea, Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BNT (Boston naming test)	speech evaluation tool for measuring the confrontational word retrieval function	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)
Secondary	WAB (Western aphasia battery)	speech evaluation tool for screening the presence, degree, and type of aphaisa	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)
Secondary	Laterality index (LI)	From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemisphereic Hbo values, respectively)	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)