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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

Tracking Information
First Submitted Date  ICMJE October 22, 2018
First Posted Date  ICMJE October 25, 2018
Last Update Posted Date October 30, 2018
Estimated Study Start Date  ICMJE December 2018
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
UPDRS part III-motor part [ Time Frame: 2 days ]
Motor functions will be checked using UPDRS.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2018)
  • 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.
  • 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.
  • The completion time during the SWS test [ Time Frame: 2 days ]
    The completion time will be recorded.
  • Freezing episodes of gait trajectory [ Time Frame: 2 days ]
    The number of freezing episodes during rapid full turns and dual task
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2018)
  • Finger tapping test with right hand [ Time Frame: 2 days ]
    Finger tapping test with right hand, as quickly as possible
  • The 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.
  • The completion time during the SWS test [ Time Frame: 2 days ]
    The completion time will be recorded.
  • Freezing episodes of gait trajectory [ Time Frame: 2 days ]
    The number of freezing episodes during rapid full turns and dual task
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE rTMS Treatment in Vascular Parkinsonism
Official Title  ICMJE Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vascular Parkinsonism
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Active Comparator: Real rTMS Supplementary motor area
    Real rTMS will be applied over the supplementary motor area
    Intervention: Device: Real rTMS Supplementary motor area
  • Sham Comparator: Sham rTMS Supplementary motor area
    Sham rTMS will be applied over the supplementary motor area
    Intervention: Device: Sham rTMS Supplementary motor area
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 22, 2018)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2025
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sang Jin Kim, MD, PhD 82-51-890-8954 jsk120@hanmail.net
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03720691
Other Study ID Numbers  ICMJE 18-0089
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sangjin Kim, Inje University
Study Sponsor  ICMJE Inje University
Collaborators  ICMJE Dongtan Sacred Heart Hospital
Investigators  ICMJE
Principal Investigator: Sang Jin Kim, MD, PhD Inje Unversity, Busan Paik Hospital
PRS Account Inje University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP