rTMS Treatment in Vascular Parkinsonism

Vascular Parkinsonism Clinical Trial

— rTMS  

Official title:

Effect of Repetitive Transcranial Magnetic Stimulation in Vascular Parkinsonism

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03720691
• Other study ID #: 18-0089
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2018
• Est. completion date: December 2025

Study information

• Verified date: October 2018
• Source: Inje University
• Contact: Sang Jin Kim, MD, PhD
• Phone: 82-51-890-8954
• Email: jsk120[@]hanmail.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinsonian Disorders
• Vascular Parkinsonism

Intervention

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.
• Sham rTMS Supplementary motor area
There will be no real brain stimulation in Sham rTMS, and participant will be blinded.

Locations

Country	Name	City	State
Korea, Republic of	Inje university, Busan Paik Hospital	Busan

Sponsors (2)

Lead Sponsor	Collaborator
Inje University	Dongtan Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	The completion time during the SWS test	The completion time will be recorded.	2 days
Secondary	Freezing episodes of gait trajectory	The number of freezing episodes during rapid full turns and dual task	2 days
Secondary	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