Balance Performance and Corticomotor Inhibition in PD

September 23, 2021 updated by: Yea-Ru Yang, National Yang Ming University

Relationship Between Balance Performance and Corticomotor Inhibition in Individuals With Parkinsons' Disease

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

people with Parkinson's disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 8, 2021

Primary Completion (Anticipated)

September 8, 2022

Study Completion (Anticipated)

September 8, 2022

Study Registration Dates

First Submitted

September 23, 2021

First Submitted That Met QC Criteria

September 23, 2021

First Posted (Actual)

October 4, 2021

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YM110122F

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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