NCT05066659

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

October 8, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2022

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 23, 2021

Last Update Submit

September 23, 2021

Conditions

Keywords

Parkinson's disease; Transcranial magnetic stimulation; Motor cortex; Corticomotor inhibition; Balance performance

Outcome Measures

Primary Outcomes (5)

  • Intracortical inhibition

    Short-interval intracortical inhibition assessed by transcranial magnetic stimulation

    20 minutes

  • Corticospinal inhibition

    Cortical silent period assessed by transcranial magnetic stimulation

    20 minutes

  • Static balance

    Sharpened Romberg test

    3 minutes

  • Dynamic balance

    Functional reach test

    5 minutes

  • Functional balance

    Mini-Balance Evaluation Systems Test

    15 minutes

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

people with Parkinson's disease

You may qualify if:

  • the Hoehn and Yahr stage between 1 and 3
  • age 40 to 80 years
  • a stable treatment of anti-PD medications

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Yea-Ru Yang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 4, 2021

Study Start

October 8, 2021

Primary Completion

September 8, 2022

Study Completion

September 8, 2022

Last Updated

October 4, 2021

Record last verified: 2021-09

Locations