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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05066659
Other study ID # YM110122F
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 8, 2021
Est. completion date September 8, 2022

Study information

Verified date September 2021
Source National Yang Ming University
Contact Yea-Ru Yang, PhD
Phone 886228267279
Email yryang@nycu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Postural instability is one of the motor features of Parkinson's disease (PD). Most patients will develop balance dysfunction, and they may get worse with disease progression. According to previous studies, people with PD had abnormal changes in corticomotor excitability, especially disinhibition in the primary motor cortex (M1). Some evidence had shown that the cortical function in the M1 is crucial for the pathophysiology of the underlying motor symptoms in PD. Furthermore, neurostimulation over the M1 could modulate the corticomotor excitability in individuals with PD, and then improve their motor and also balance performance. However, whether the impaired corticomotor inhibition relates to balance dysfunction in people with PD is still unknown. In this study, the purpose is to investigate the possible relationship between corticomotor inhibition and balance performance in individuals with PD. However, the postural position during TMS measurement may affect the corticomotor excitability. To further establish the above-mentioned relationship, the secondary purpose is to explore and confirm whether the postural position will influence the correlation.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date September 8, 2022
Est. primary completion date September 8, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria: - the Hoehn and Yahr stage between 1 and 3 - age 40 to 80 years - a stable treatment of anti-PD medications Exclusion Criteria: - any contraindications of TMS - any injury histories or disorders affecting balance - any neurosurgery experience - neurologic conditions other than PD - the Mini-mental State Examination (MMSE) score < 24

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intracortical inhibition Short-interval intracortical inhibition assessed by transcranial magnetic stimulation 20 minutes
Primary Corticospinal inhibition Cortical silent period assessed by transcranial magnetic stimulation 20 minutes
Primary Static balance Sharpened Romberg test 3 minutes
Primary Dynamic balance Functional reach test 5 minutes
Primary Functional balance Mini-Balance Evaluation Systems Test 15 minutes
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