rTMS Treatment in Vascular Parkinsonism

NCT ID: NCT03720691

Last Updated: 2018-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2025-12-31

Brief Summary

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Vascular parkinsonism (VP), parkinsonism resulting from ischemic cerebrovascular disease, was suggested in 1929. The main features are wide-based gait, postural instability, and falls, which make patients with VP frustrated. Currently, the treatment is challenging.

Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain, and repetitive transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to explore the therapeutic effect of rTMS for the VP.

Detailed Description

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Conditions

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Vascular Parkinsonism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Real rTMS Supplementary motor area

Real rTMS will be applied over the supplementary motor area

Group Type ACTIVE_COMPARATOR

Real rTMS Supplementary motor area

Intervention Type DEVICE

There will be a series of four rTMS blocks separated by 10 minutes. Each block will consist of 15 to 25 pulse trains of 1-second duration at 25 Hz, with an intertrain interval of 10 seconds.

Sham rTMS Supplementary motor area

Sham rTMS will be applied over the supplementary motor area

Group Type SHAM_COMPARATOR

Sham rTMS Supplementary motor area

Intervention Type DEVICE

There will be no real brain stimulation in Sham rTMS, and participant will be blinded.

Interventions

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Real rTMS Supplementary motor area

There will be a series of four rTMS blocks separated by 10 minutes. Each block will consist of 15 to 25 pulse trains of 1-second duration at 25 Hz, with an intertrain interval of 10 seconds.

Intervention Type DEVICE

Sham rTMS Supplementary motor area

There will be no real brain stimulation in Sham rTMS, and participant will be blinded.

Intervention Type DEVICE

Other Intervention Names

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Real repetitive transcranial magnetic stimulation Sham repetitive transcranial magnetic stimulation

Eligibility Criteria

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Inclusion Criteria

* Vascular parkinsonism
* age 18 and older

Exclusion Criteria

* pregnant or any, other medical, surgical, neurological or psychiatric conditions
* other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
* any past or current history of seizure disorder or epilepsy
* unable to give informed consent
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dongtan Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role lead

Responsible Party

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Sangjin Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang Jin Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Inje Unversity, Busan Paik Hospital

Locations

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Inje university, Busan Paik Hospital

Busan, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Sang Jin Kim, MD, PhD

Role: CONTACT

82-51-890-8954

Other Identifiers

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18-0089

Identifier Type: -

Identifier Source: org_study_id

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