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rTMS in Facilitation of Working Memory in PD

Primary Purpose

Parkinson Disease

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

rTMS

Cognitive training program

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring working memory, parkinson's disease, cognition, rTMS

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Taipei Veteran General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Arm Label

High frequency rTMS

High frequency rTMS with cognitive training

Sham rTMS

Arm Description

Real rTMS, one session per day, for 10 days

Real rTMS and cognitive training, one session per day, for 10 days

Sham rTMS, one session per day, for 10 days

Outcomes

Primary Outcome Measures

Change of Repeatable Battery for the Assessment of Neuropsychological Status

This battery measures the cognitive functions including attention, memory, language, visuospatial domains.

Secondary Outcome Measures

Change of Montreal Cognitive Assessment ; MoCA

Assessing cognitive function including delaying recall, attention, executive function, language...

Full Information

NCT ID

NCT03059212

First Posted

January 16, 2017

Last Updated

January 5, 2021

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT03059212

Brief Title

rTMS in Facilitation of Working Memory in PD

Official Title

rTMS in Facilitation of Working Memory in PD

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 30, 2017 (Actual)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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 cortex.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

working memory, parkinson's disease, cognition, rTMS

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Real rTMS, sham rTMS

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High frequency rTMS

Arm Type

Experimental

Arm Description

Real rTMS, one session per day, for 10 days

Arm Title

High frequency rTMS with cognitive training

Arm Type

Experimental

Arm Description

Real rTMS and cognitive training, one session per day, for 10 days

Arm Title

Sham rTMS

Arm Type

Sham Comparator

Arm Description

Sham rTMS, one session per day, for 10 days

Intervention Type

Device

Intervention Name(s)

rTMS

Intervention Description

High frequency rTMS for 3 to 10 min to increase the excitability of cortex.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive training program

Intervention Description

A rehabilitation protocol that facilitates attention, memory, execution.

Primary Outcome Measure Information:

Title

Change of Repeatable Battery for the Assessment of Neuropsychological Status

Description

This battery measures the cognitive functions including attention, memory, language, visuospatial domains.

Time Frame

up to 12 weeks

Secondary Outcome Measure Information:

Title

Change of Montreal Cognitive Assessment ; MoCA

Description

Assessing cognitive function including delaying recall, attention, executive function, language...

Time Frame

up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Po-Yi Tsai, MD

Phone

886-22875729

Ext

vivitsai0518@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 Veteran 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

886-22875729

Ext

vivitsai0518@gmail.com

First Name & Middle Initial & Last Name & Degree

Po-Yi Tsai, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19309294

Citation

Preston G, Anderson E, Silva C, Goldberg T, Wassermann EM. Effects of 10 Hz rTMS on the neural efficiency of working memory. J Cogn Neurosci. 2010 Mar;22(3):447-56. doi: 10.1162/jocn.2009.21209.

Results Reference

result

Links:

URL

http://www.ncbi.nlm.nih.gov/pubmed/23194830

Description

Description Related Info

URL

http://www.ncbi.nlm.nih.gov/pubmed/21980359

Description

Description Related Info

URL

http://www.ncbi.nlm.nih.gov/pubmed/19309294

Description

Description Related Info

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rTMS in Facilitation of Working Memory in PD

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