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rTMS Treatment in Vascular Parkinsonism (rTMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03720691
Recruitment Status : Not yet recruiting
First Posted : October 25, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborator:
Dongtan Sacred Heart Hospital
Information provided by (Responsible Party):
Sangjin Kim, Inje University

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.


Condition or disease Intervention/treatment Phase
Vascular Parkinsonism Device: Real rTMS Supplementary motor area Device: Sham rTMS Supplementary motor area Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Real rTMS Supplementary motor area
Real rTMS will be applied over the supplementary motor area
Device: 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.
Other Name: Real repetitive transcranial magnetic stimulation

Sham Comparator: Sham rTMS Supplementary motor area
Sham rTMS will be applied over the supplementary motor area
Device: Sham rTMS Supplementary motor area
There will be no real brain stimulation in Sham rTMS, and participant will be blinded.
Other Name: Sham repetitive transcranial magnetic stimulation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. The completion time during the SWS test [ Time Frame: 2 days ]
    The completion time will be recorded.

  4. Freezing episodes of gait trajectory [ Time Frame: 2 days ]
    The number of freezing episodes during rapid full turns and dual task

  5. 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).



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720691


Contacts
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Contact: Sang Jin Kim, MD, PhD 82-51-890-8954 jsk120@hanmail.net

Locations
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Korea, Republic of
Inje university, Busan Paik Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
Inje University
Dongtan Sacred Heart Hospital
Investigators
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Principal Investigator: Sang Jin Kim, MD, PhD Inje Unversity, Busan Paik Hospital

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Responsible Party: Sangjin Kim, Professor, Inje University
ClinicalTrials.gov Identifier: NCT03720691    
Other Study ID Numbers: 18-0089
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sangjin Kim, Inje University:
parkinsonism
vascular parkinsonism
repetitive transcranial magnetic stimulation
brain stimulation
Additional relevant MeSH terms:
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Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders