The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 5, 2013
CompletedFirst Posted
Study publicly available on registry
December 10, 2013
CompletedStudy Start
First participant enrolled
June 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 11, 2021
CompletedJanuary 11, 2021
January 1, 2021
4.1 years
December 5, 2013
January 6, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change of Repeatable Battery for the Assessment of Neuropsychological Status
Test cognition including memory, attention, language...
Up to 12 weeks
Secondary Outcomes (2)
Change of Montreal Cognitive Assessment
Up to 12 weeks
Change of Fugl-Meyer Assessment , Wolf Motor Function Test
Up to 12 weeks
Other Outcomes (1)
Change of hand grip, pinch power
Up to 12 weeks
Study Arms (3)
High frequency rTMS plus fNIRS
EXPERIMENTALrTMS with neuroimage assessment of functional near infrared spectroscopy
Sham rTMS
SHAM COMPARATORSham stimulation
High frequency rTMS
EXPERIMENTALHigh frequency rTMS to modulate brain areas
Interventions
Using high-sensitivity infrared to detect the active brain areas
Eligibility Criteria
You may qualify if:
- Ischemic or hemorrhagic cerebrovascular lesion,
- Parkinson's disease
You may not qualify if:
- Seizure
- With metal implantation
- Dementia or severe cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Veterans General Hospital
Taipei, 11217, Taiwan
Related Publications (3)
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.
PMID: 34773596DERIVEDTsai 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.
PMID: 32159313DERIVEDLai 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.
PMID: 25218256DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Po-Yi Tsai, MD
Taipei Veterans General Hospital, Taiwan
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
December 5, 2013
First Posted
December 10, 2013
Study Start
June 2, 2017
Primary Completion
July 11, 2021
Study Completion
July 11, 2021
Last Updated
January 11, 2021
Record last verified: 2021-01