NCT03059212

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

October 30, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 8, 2021

Status Verified

January 1, 2021

Enrollment Period

4.1 years

First QC Date

January 16, 2017

Last Update Submit

January 5, 2021

Conditions

Keywords

working memoryparkinson's diseasecognitionrTMS

Outcome Measures

Primary Outcomes (1)

  • Change of Repeatable Battery for the Assessment of Neuropsychological Status

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

    up to 12 weeks

Secondary Outcomes (1)

  • Change of Montreal Cognitive Assessment ; MoCA

    up to 12 weeks

Study Arms (3)

High frequency rTMS

EXPERIMENTAL

Real rTMS, one session per day, for 10 days

Device: rTMS

High frequency rTMS with cognitive training

EXPERIMENTAL

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

Device: rTMSBehavioral: Cognitive training program

Sham rTMS

SHAM COMPARATOR

Sham rTMS, one session per day, for 10 days

Device: rTMS

Interventions

rTMSDEVICE

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

High frequency rTMSHigh frequency rTMS with cognitive trainingSham rTMS

A rehabilitation protocol that facilitates attention, memory, execution.

High frequency rTMS with cognitive training

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veteran General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Po-Yi Tsai, MD

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

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
Model Details: Real rTMS, sham rTMS
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 16, 2017

First Posted

February 23, 2017

Study Start

October 30, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 8, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations