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The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory

Sponsor
Taipei Veterans General Hospital, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT02006615
Collaborator
(none)
150
Enrollment
1
Location
3
Arms
49.3
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Functional near infrared spectroscopy
  • Device: rTMS
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 2, 2017
Anticipated Primary Completion Date :
Jul 11, 2021
Anticipated Study Completion Date :
Jul 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: High frequency rTMS plus fNIRS

rTMS with neuroimage assessment of functional near infrared spectroscopy

Device: Functional near infrared spectroscopy
Using high-sensitivity infrared to detect the active brain areas
Other Names:
  • fNIRS

    • Device: rTMS
    To modulate brain cortex
    Sham Comparator: Sham rTMS

    Sham stimulation

    Device: rTMS
    To modulate brain cortex
    Experimental: High frequency rTMS

    High frequency rTMS to modulate brain areas

    Device: rTMS
    To modulate brain cortex

    Outcome Measures

    Primary Outcome Measures

    1. Change of Repeatable Battery for the Assessment of Neuropsychological Status [Up to 12 weeks]

      Test cognition including memory, attention, language...

    Secondary Outcome Measures

    1. Change of Montreal Cognitive Assessment [Up to 12 weeks]

      Test cognition including memory, attention, and language.

    2. Change of Fugl-Meyer Assessment , Wolf Motor Function Test [Up to 12 weeks]

      Test upper limb motor function.

    Other Outcome Measures

    1. Change of hand grip, pinch power [Up to 12 weeks]

      Test hand strength.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Ischemic or hemorrhagic cerebrovascular lesion,

    2. Parkinson's disease

    Exclusion Criteria:

    • Seizure

    • With metal implantation

    • Dementia or severe cognitive impairment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Taipei Veterans General Hospital Taipei Taiwan 11217

    Sponsors and Collaborators

    • Taipei Veterans General Hospital, Taiwan

    Investigators

    • Principal Investigator: Po-Yi Tsai, MD, Taipei Veterans General Hospital, Taiwan

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    vghtpe user, Principal investigator, Taipei Veterans General Hospital, Taiwan
    ClinicalTrials.gov Identifier:
    NCT02006615
    Other Study ID Numbers:
    • 2013-07-011A
    First Posted:
    Dec 10, 2013
    Last Update Posted:
    Jan 11, 2021
    Last Verified:
    Jan 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nervous System Diseases
    Central Nervous System Diseases

    Study Results

    No Results Posted as of Jan 11, 2021