Vascular ParkinsonismrTMSNCT03720691
rTMS Treatment in Vascular Parkinsonism
A study testing Real rTMS Supplementary motor area in people with Vascular Parkinsonism, run by Inje University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vascular Parkinsonism
- What is being tested?
- Real rTMS Supplementary motor area
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2018to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Vascular parkinsonism
- age 18 and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vascular Parkinsonism
- Being tested
- Real rTMS Supplementary motor area, Sham rTMS Supplementary motor area
- Keywords
- parkinsonism, vascular parkinsonism, repetitive transcranial magnetic stimulation, brain stimulation
- Medical subject headings
- Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real rTMS Supplementary motor areaDevice
Also called Real repetitive transcranial magnetic stimulation
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.
Sham rTMS Supplementary motor areaDevice
Also called Sham repetitive transcranial magnetic stimulation
There will be no real brain stimulation in Sham rTMS, and participant will be blinded.
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS Supplementary motor area | Active comparator | Real rTMS will be applied over the supplementary motor area Receives: Device: Real rTMS Supplementary motor area |
| Sham rTMS Supplementary motor area | Sham comparator | Sham rTMS will be applied over the supplementary motor area Receives: Device: Sham rTMS Supplementary motor area |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (5)
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.
Measured: 2 days
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.
Measured: 2 days
The completion time during the SWS test
The completion time will be recorded.
Measured: 2 days
Freezing episodes of gait trajectory
The number of freezing episodes during rapid full turns and dual task
Measured: 2 days
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).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular ParkinsonismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- Dongtan Sacred Heart Hospital
- Responsible party
- Principal investigator, Sangjin Kim, Inje University
- Investigators
- Sang Jin Kim, MD, PhD, Principal investigator, Inje Unversity, Busan Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720691
- Sponsor's protocol ID
- 18-0089
- Acronym
- rTMS
- Status last verified
- Oct 2018
- First submitted
- 22 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism
- ClinicalTrials.gov ID
- NCT03720691
- Acronym / sponsor ID
- rTMS / 18-0089
- Conditions
- Vascular Parkinsonism
- Keywords
- parkinsonism, vascular parkinsonism, repetitive transcranial magnetic stimulation, brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- Dongtan Sacred Heart Hospital
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 25 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real rTMS Supplementary motor area | Active comparator | Device: Real rTMS Supplementary motor areaReal rTMS will be applied over the supplementary motor area |
| Sham rTMS Supplementary motor area | Sham comparator | Device: Sham rTMS Supplementary motor areaSham rTMS will be applied over the supplementary motor area |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vascular parkinsonism
- age 18 and older
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real rTMS Supplementary motor areaAlso: Real repetitive transcranial magnetic stimulationThere 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. | Device | Real rTMS Supplementary motor area |
| Sham rTMS Supplementary motor areaAlso: Sham repetitive transcranial magnetic stimulationThere will be no real brain stimulation in Sham rTMS, and participant will be blinded. | Device | Sham rTMS Supplementary motor area |
Primary outcome
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.
5 secondary outcomes
Finger tapping test with right hand
Time frame: 2 days
The total number of steps during the stand-walk-sit (SWS) test
Time frame: 2 days
The completion time during the SWS test
Time frame: 2 days
Freezing episodes of gait trajectory
Time frame: 2 days
Patient and Clinical Global Impression Scale
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang Jin Kim, MD, PhD principal investigator
Inje Unversity, Busan Paik Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real rTMS Supplementary motor area in people with Vascular Parkinsonism, run by Inje University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Jin Kim, MD, PhD (82-51-890-8954, jsk120@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.