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

Primary Purpose

Stroke, Aphasia

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
High frequency rTMS
Low frequency rTMS
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High frequency rTMS

Low Frequency rTMS

Arm Description

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

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

Outcomes

Primary Outcome Measures

BNT (Boston naming test)
speech evaluation tool for measuring the confrontational word retrieval function

Secondary Outcome Measures

WAB (Western aphasia battery)
speech evaluation tool for screening the presence, degree, and type of aphaisa
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)

Full Information

First Posted
September 13, 2015
Last Updated
August 29, 2022
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02556385
Brief Title
Effects of rTMS Based on Brain Activation During Language Performance in Stroke Patients With Non-fluent Aphasia
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
August 24, 2017 (Actual)
Study Completion Date
August 24, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High frequency rTMS
Arm Type
Experimental
Arm Description
Most activated area from fNIRS with language task: Perileisional Broca's area
Arm Title
Low Frequency rTMS
Arm Type
Active Comparator
Arm Description
Most activated area from fNIRS with language task: Contralesional homologs of Broca's area
Intervention Type
Device
Intervention Name(s)
High frequency rTMS
Intervention Description
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
Intervention Name(s)
Low frequency rTMS
Intervention Description
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 Outcome Measure Information:
Title
BNT (Boston naming test)
Description
speech evaluation tool for measuring the confrontational word retrieval function
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)
Secondary Outcome Measure Information:
Title
WAB (Western aphasia battery)
Description
speech evaluation tool for screening the presence, degree, and type of aphaisa
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)
Title
Laterality index (LI)
Description
From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemisphereic Hbo values, respectively)
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Organizational Affiliation
Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Korea, Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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