The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory
Primary Purpose
Central Nervous System Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Functional near infrared spectroscopy
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Central Nervous System Diseases
Eligibility Criteria
Inclusion Criteria:
- Ischemic or hemorrhagic cerebrovascular lesion,
- Parkinson's disease
Exclusion Criteria:
- Seizure
- With metal implantation
- Dementia or severe cognitive impairment
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Experimental
Arm Label
High frequency rTMS plus fNIRS
Sham rTMS
High frequency rTMS
Arm Description
rTMS with neuroimage assessment of functional near infrared spectroscopy
Sham stimulation
High frequency rTMS to modulate brain areas
Outcomes
Primary Outcome Measures
Change of Repeatable Battery for the Assessment of Neuropsychological Status
Test cognition including memory, attention, language...
Secondary Outcome Measures
Change of Montreal Cognitive Assessment
Test cognition including memory, attention, and language.
Change of Fugl-Meyer Assessment , Wolf Motor Function Test
Test upper limb motor function.
Full Information
NCT ID
NCT02006615
First Posted
December 5, 2013
Last Updated
January 6, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
1. Study Identification
Unique Protocol Identification Number
NCT02006615
Brief Title
The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory
Official Title
The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory in Stroke, Parkinson, and Elderly Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
July 11, 2021 (Anticipated)
Study Completion Date
July 11, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The investigators hypothesize that ten sessions of repetitive transcranial magnetic stimulation yield ability to upregulate the function of primary motor cortex and prefrontal cortex that play key roles in motor and frontal memory processing.
Detailed Description
Excitatory (>3Hz) rTMS could facilitate the brain cortex and neuroplasticity that benefits motor control and working memory when the coil is applied over primary motor cortex or dorsolateral prefrontal gyrus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Nervous System Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High frequency rTMS plus fNIRS
Arm Type
Experimental
Arm Description
rTMS with neuroimage assessment of functional near infrared spectroscopy
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham stimulation
Arm Title
High frequency rTMS
Arm Type
Experimental
Arm Description
High frequency rTMS to modulate brain areas
Intervention Type
Device
Intervention Name(s)
Functional near infrared spectroscopy
Other Intervention Name(s)
fNIRS
Intervention Description
Using high-sensitivity infrared to detect the active brain areas
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
To modulate brain cortex
Primary Outcome Measure Information:
Title
Change of Repeatable Battery for the Assessment of Neuropsychological Status
Description
Test cognition including memory, attention, language...
Time Frame
Up to 12 weeks
Secondary Outcome Measure Information:
Title
Change of Montreal Cognitive Assessment
Description
Test cognition including memory, attention, and language.
Time Frame
Up to 12 weeks
Title
Change of Fugl-Meyer Assessment , Wolf Motor Function Test
Description
Test upper limb motor function.
Time Frame
Up to 12 weeks
Other Pre-specified Outcome Measures:
Title
Change of hand grip, pinch power
Description
Test hand strength.
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ischemic or hemorrhagic cerebrovascular lesion,
Parkinson's disease
Exclusion Criteria:
Seizure
With metal implantation
Dementia or severe cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Po-Yi Tsai, MD
Phone
886-228757293
Email
vivitsai0518@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Jou Lai, MD
Phone
886-228757361
Email
milly1204@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai, MD
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Po-Yi Tsai, MD
Phone
886-228757293
Email
vivitsai0518@gmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
34773596
Citation
Chang PW, Lu CF, Chang ST, Tsai PY. Functional Near-Infrared Spectroscopy as a Target Navigator for rTMS Modulation in Patients with Hemiplegia: A Randomized Control Study. Neurol Ther. 2022 Mar;11(1):103-121. doi: 10.1007/s40120-021-00300-0. Epub 2021 Nov 13.
Results Reference
derived
PubMed Identifier
32159313
Citation
Tsai PY, Lin WS, Tsai KT, Kuo CY, Lin PH. High-frequency versus theta burst transcranial magnetic stimulation for the treatment of poststroke cognitive impairment in humans. J Psychiatry Neurosci. 2020 Jul 1;45(4):262-270. doi: 10.1503/jpn.190060.
Results Reference
derived
PubMed Identifier
25218256
Citation
Lai CJ, Wang CP, Tsai PY, Chan RC, Lin SH, Lin FG, Hsieh CY. Corticospinal integrity and motor impairment predict outcomes after excitatory repetitive transcranial magnetic stimulation: a preliminary study. Arch Phys Med Rehabil. 2015 Jan;96(1):69-75. doi: 10.1016/j.apmr.2014.08.014. Epub 2014 Sep 11.
Results Reference
derived
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/23194830
Description
Document of rTMS effect in functional facilitation
URL
http://www.ncbi.nlm.nih.gov/pubmed/21980359
Description
Document of rTMS effect in functional facilitation
URL
http://www.ncbi.nlm.nih.gov/pubmed/19309294
Description
Document of rTMS effect in functional facilitation
Learn more about this trial
The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory
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