rTMS Treatment in Vascular Parkinsonism (rTMS)

October 27, 2018 updated by: Sangjin Kim, Inje University

Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

32

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

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Real rTMS Supplementary motor area
Real rTMS will be applied over the 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.
Other Names:
  • Real repetitive transcranial magnetic stimulation
Sham Comparator: Sham rTMS Supplementary motor area
Sham rTMS will be applied over the supplementary motor area
There will be no real brain stimulation in Sham rTMS, and participant will be blinded.
Other Names:
  • Sham repetitive transcranial magnetic stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS)
Time Frame: 2 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finger tapping test with right hand
Time Frame: 2 days
Finger tapping test with right hand, as quickly as possible for 15 second. The total number of taps will be calculated. The test will be twice with one minute interval. After the test performed twice, the average of the tests will be used.
2 days
The total number of steps during the stand-walk-sit (SWS) test
Time Frame: 2 days
SWS test is Standing up, making a 9 m round trip, and sitting down as quickly as possible. The number of steps will be recorded.
2 days
The completion time during the SWS test
Time Frame: 2 days
The completion time will be recorded.
2 days
Freezing episodes of gait trajectory
Time Frame: 2 days
The number of freezing episodes during rapid full turns and dual task
2 days
Patient and Clinical Global Impression Scale
Time Frame: 2 days
7-point scale that requires the patient (or clinician) to rate the response of the interventions. The rating will be numbered (1: very much improved; 2: much improved; 3: minimally improved; 4: no changes; 5: minimally worse; 6: much worse; 7: very much worse).
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Sang Jin Kim, MD, PhD, Inje Unversity, Busan Paik Hospital

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 (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 25, 2018

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 27, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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