rTMS Treatment in Vascular Parkinsonism (rTMS)
Primary Purpose
Vascular Parkinsonism
Status
Not yet recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Real rTMS Supplementary motor area
Sham rTMS Supplementary motor area
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Parkinsonism focused on measuring parkinsonism, vascular parkinsonism, repetitive transcranial magnetic stimulation, brain stimulation
Eligibility 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
Sites / Locations
- Inje university, Busan Paik Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Real rTMS Supplementary motor area
Sham rTMS Supplementary motor area
Arm Description
Real rTMS will be applied over the supplementary motor area
Sham rTMS will be applied over the supplementary motor area
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Finger tapping test with right hand
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
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
The completion time will be recorded.
Freezing episodes of gait trajectory
The number of freezing episodes during rapid full turns and dual task
Patient and Clinical Global Impression Scale
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).
Full Information
NCT ID
NCT03720691
First Posted
October 22, 2018
Last Updated
October 27, 2018
Sponsor
Inje University
Collaborators
Dongtan Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03720691
Brief Title
rTMS Treatment in Vascular Parkinsonism
Acronym
rTMS
Official Title
Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University
Collaborators
Dongtan Sacred Heart Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Parkinsonism
Keywords
parkinsonism, vascular parkinsonism, repetitive transcranial magnetic stimulation, brain stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real rTMS Supplementary motor area
Arm Type
Active Comparator
Arm Description
Real rTMS will be applied over the supplementary motor area
Arm Title
Sham rTMS Supplementary motor area
Arm Type
Sham Comparator
Arm Description
Sham rTMS will be applied over the supplementary motor area
Intervention Type
Device
Intervention Name(s)
Real rTMS Supplementary motor area
Other Intervention Name(s)
Real repetitive transcranial magnetic stimulation
Intervention Description
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
Intervention Name(s)
Sham rTMS Supplementary motor area
Other Intervention Name(s)
Sham repetitive transcranial magnetic stimulation
Intervention Description
There will be no real brain stimulation in Sham rTMS, and participant will be blinded.
Primary Outcome Measure Information:
Title
Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS)
Description
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.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Finger tapping test with right hand
Description
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.
Time Frame
2 days
Title
The total number of steps during the stand-walk-sit (SWS) test
Description
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.
Time Frame
2 days
Title
The completion time during the SWS test
Description
The completion time will be recorded.
Time Frame
2 days
Title
Freezing episodes of gait trajectory
Description
The number of freezing episodes during rapid full turns and dual task
Time Frame
2 days
Title
Patient and Clinical Global Impression Scale
Description
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).
Time Frame
2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Jin Kim, MD, PhD
Phone
82-51-890-8954
Email
jsk120@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Jin Kim, MD, PhD
Organizational Affiliation
Inje Unversity, Busan Paik Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje university, Busan Paik Hospital
City
Busan
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
rTMS Treatment in Vascular Parkinsonism
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