rTMS Treatment in Vascular Parkinsonism

Not Applicable

Not yet recruiting

• Conditions: Vascular Parkinsonism
• Interventions: Device: Real rTMS Supplementary motor area; Device: Sham rTMS Supplementary motor area

• Registration Number: NCT03720691
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-22
• Study First Posted: 2018-10-25
• Last Update Submitted: 2018-10-27
• Last Update Posted: 2018-10-30
• Study Start: 2018-12
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real rTMS Supplementary motor area	Real rTMS Supplementary motor area	Real rTMS will be applied over the supplementary motor area
Sham rTMS Supplementary motor area	Sham rTMS Supplementary motor area	Sham rTMS will be applied over the supplementary motor area

Primary Outcome Measures

Name	Time	Method
Unified Parkinson's Disease Rating Scale (UPDRS) part III-motor part (Number 18 ~31 of UPDRS)	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

Name	Time	Method
The total number of steps during the stand-walk-sit (SWS) test	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.
Freezing episodes of gait trajectory	2 days	The number of freezing episodes during rapid full turns and dual task
Finger tapping test with right hand	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 completion time during the SWS test	2 days	The completion time will be recorded.
Patient and Clinical Global Impression Scale	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).

Trial Locations

Locations (1)

Inje university, Busan Paik Hospital; 🇰🇷 Busan, Korea, Republic of