rTMS in Facilitation of Working Memory in PD

January 5, 2021 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan
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

Recruiting

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 cortex.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veteran 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

28 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of Parkinson's Disease
  • With symptoms of cognitive impairments, such as memory, attention, or language decline.

Exclusion Criteria:

  • History of seizure attack
  • Alzheimer's disease
  • With cardiac pacemaker implantation

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
Real rTMS, one session per day, for 10 days
Device: rTMS
High frequency rTMS for 3 to 10 min to increase the excitability of cortex.
Experimental: High frequency rTMS with cognitive training
Real rTMS and cognitive training, one session per day, for 10 days
Device: rTMS
High frequency rTMS for 3 to 10 min to increase the excitability of cortex.
Behavioral: Cognitive training program
A rehabilitation protocol that facilitates attention, memory, execution.
Sham Comparator: Sham rTMS
Sham rTMS, one session per day, for 10 days
Device: rTMS
High frequency rTMS for 3 to 10 min to increase the excitability of 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
This battery measures the cognitive functions including attention, memory, language, visuospatial domains.
up to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Montreal Cognitive Assessment ; MoCA
Time Frame: up to 12 weeks
Assessing cognitive function including delaying recall, attention, executive function, language...
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)

October 30, 2017

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 5, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-10-018A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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