NCT03720691

Brief Summary

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.

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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

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

October 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

6 years

First QC Date

October 22, 2018

Last Update Submit

October 27, 2018

Conditions

Vascular Parkinsonism

Keywords

parkinsonismvascular parkinsonismrepetitive transcranial magnetic stimulationbrain stimulation

Outcome Measures

Primary Outcomes (1)

  • Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS)

    Motor functions will be checked using UPDRS. Each item of the motor part ranges from 0 to 4 (0 means normal, 4 means worst condition). Total sum will be calculated.

    2 days

Secondary Outcomes (5)

  • Finger tapping test with right hand

    2 days

  • The total number of steps during the stand-walk-sit (SWS) test

    2 days

  • The completion time during the SWS test

    2 days

  • Freezing episodes of gait trajectory

    2 days

  • Patient and Clinical Global Impression Scale

    2 days

Study Arms (2)

Real rTMS Supplementary motor area

ACTIVE COMPARATOR

Real rTMS will be applied over the supplementary motor area

Device: Real rTMS Supplementary motor area

Sham rTMS Supplementary motor area

SHAM COMPARATOR

Sham rTMS will be applied over the supplementary motor area

Device: Sham rTMS Supplementary motor area

Interventions

Real rTMS Supplementary motor areaDEVICE

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.

Also known as: Real repetitive transcranial magnetic stimulation
Real rTMS Supplementary motor area
Sham rTMS Supplementary motor areaDEVICE

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

Also known as: Sham repetitive transcranial magnetic stimulation
Sham rTMS Supplementary motor area

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vascular parkinsonism
  • age 18 and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje university, Busan Paik Hospital

Busan, South Korea

Location

MeSH Terms

Conditions

Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement Disorders

Study Officials

  • Sang Jin Kim, MD, PhD

    Inje Unversity, Busan Paik Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Jin Kim, MD, PhD

CONTACT

82-51-890-8954jsk120@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 25, 2018

Study Start

December 1, 2018

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations

KR(1)