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

January 6, 2021 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan

The Role of Primary Motor Cortex and Prefrontal Cortex for Facilitation of Motor System and Working Memory in Stroke, Parkinson, and Elderly Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Ischemic or hemorrhagic cerebrovascular lesion,
  2. Parkinson's disease

Exclusion Criteria:

  • Seizure
  • With metal implantation
  • Dementia or severe cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Repeatable Battery for the Assessment of Neuropsychological Status
Time Frame: Up to 12 weeks
Test cognition including memory, attention, language...
Up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Montreal Cognitive Assessment
Time Frame: Up to 12 weeks
Test cognition including memory, attention, and language.
Up to 12 weeks
Change of Fugl-Meyer Assessment , Wolf Motor Function Test
Time Frame: Up to 12 weeks
Test upper limb motor function.
Up to 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of hand grip, pinch power
Time Frame: Up to 12 weeks
Test hand strength.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2017

Primary Completion (Anticipated)

July 11, 2021

Study Completion (Anticipated)

July 11, 2021

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-07-011A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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