rTMS Treatment in Vascular Parkinsonism

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism

Conditions
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Vascular Parkinsonism

Intervention / Treatment
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* Device: Real rTMS Supplementary motor area
* Device: Sham rTMS Supplementary motor area


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real rTMS Supplementary motor area<br>Real rTMS will be applied over the supplementary motor area | Device: Real rTMS Supplementary motor area<br>* 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.<br>* Other names: Real repetitive transcranial magnetic stimulation;|
| Sham Comparator: Sham rTMS Supplementary motor area<br>Sham rTMS will be applied over the supplementary motor area | Device: Sham rTMS Supplementary motor area<br>* There will be no real brain stimulation in Sham rTMS, and participant will be blinded.<br>* Other names: Sham repetitive transcranial magnetic stimulation;|

What is the study measuring?
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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) | 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 | 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 | 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 | The completion time will be recorded. | 2 days | 
| Freezing episodes of gait trajectory | The number of freezing episodes during rapid full turns and dual task | 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). | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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parkinsonism, vascular parkinsonism, repetitive transcranial magnetic stimulation, brain stimulation