Effects of rTMS Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia
Primary Purpose
Stroke, Aphasia
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MagPro magnetic stimulator (HF rTMS)
MagPro magnetic stimulator (sham)
MagPro magnetic stimulator (LF rTMS)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Functional Near-Infrared Spectroscopy, Stroke, Aphasia, Repetitive Transcranial Magnetic Stimulation
Eligibility Criteria
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
Sites / Locations
- Department of Rehabilitation Medicine, Seoul National University College of Medicine, Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Active Comparator
Arm Label
MagPro magnetic stimulator (HF rTMS)
MagPro magnetic stimulator (sham)
MagPro magnetic stimulator (LF rTMS)
Arm Description
Most activated area from fNIRS with language task: Perilesional Broca's area
Most activated area from fNIRS with language task: Perilesional 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 aphasia)
Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'
LI (Laterality Index; From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemispheric HbO (oxyhemoglobin) or total Hb values, respectively)
Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'
BNT (Boston Naming Test)
speech evaluation tool for measuring the confrontational word retrieval function
Full Information
NCT ID
NCT02591719
First Posted
October 22, 2015
Last Updated
August 29, 2022
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02591719
Brief Title
Effects of rTMS Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia
Official Title
Effects of Repetitive Transcranial Magnetic Stimulation Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 2015 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
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 repetitive transcranial magnetic stimulation (rTMS) based on hemodynamic brain activity pattern with functional near infrared spectroscopy (fNIRS) in early poststroke nonfluent aphasia patients.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Aphasia
Keywords
Functional Near-Infrared Spectroscopy, Stroke, Aphasia, Repetitive Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MagPro magnetic stimulator (HF rTMS)
Arm Type
Experimental
Arm Description
Most activated area from fNIRS with language task: Perilesional Broca's area
Arm Title
MagPro magnetic stimulator (sham)
Arm Type
Sham Comparator
Arm Description
Most activated area from fNIRS with language task: Perilesional Broca's area
Arm Title
MagPro magnetic stimulator (LF 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)
MagPro magnetic stimulator (HF rTMS)
Other Intervention Name(s)
High frequency rTMS
Intervention Description
Most activated area from fNIRS findings: Perilesional Broca's area. Use the true coil. 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)
MagPro magnetic stimulator (sham)
Other Intervention Name(s)
Sham stimulation
Intervention Description
Most activated area from fNIRS findings: Perilesional Broca's area. Use the sham coil. 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)
MagPro magnetic stimulator (LF rTMS)
Other Intervention Name(s)
low frequency rTMS
Intervention Description
Most activated area from fNIRS findings: Contralesional homologs of Broca's area.
Use the true coil. 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
up to 2 weeks
Secondary Outcome Measure Information:
Title
WAB (Western Aphasia Battery;speech evaluation tool for screening the presence, degree, and type of aphasia)
Description
Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'
Time Frame
up to 6 weeks
Title
LI (Laterality Index; From fNIRS findings, LI=L-R/L+R (L and R represent maximum or mean left and Right hemispheric HbO (oxyhemoglobin) or total Hb values, respectively)
Description
Baseline(when allocated to each study arm), after the completion of 10 session of 'rTMS+speech therapy' (that is, 2 weeks later from the baseline), 4 weeks later after the completion of 10 session of 'rTMS+speech therapy'
Time Frame
up to 6 weeks
Title
BNT (Boston Naming Test)
Description
speech evaluation tool for measuring the confrontational word retrieval function
Time Frame
4 weeks
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nam-Jong Paik, MD, PhD
Phone
82-031-787-7731
Email
njpaik@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Ji-Young Lee, MD
Phone
82-031-787-6883
Email
bluebelll@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Organizational Affiliation
Department of Rehabilitation Medicine, 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nam-Jong Paik, MD, PhD
Phone
82-031-787-7731
Email
njpaik@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Kyoung tae Kim, MD
Email
zealot42@naver.com
First Name & Middle Initial & Last Name & Degree
Nam-jong Paik, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Effects of rTMS Based on Hemodynamic Activity for Language Recovery in Early Poststroke Aphasia
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