Parkinson DiseaseNCT05066659
Balance Performance and Corticomotor Inhibition in PD
An observational study of Parkinson Disease, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Oct 2021to 8 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: people with Parkinson's disease
Who may be able to join
- the Hoehn and Yahr stage between 1 and 3
- age 40 to 80 years
- a stable treatment of anti-PD medications
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Physical Therapy and Assistive Technology, National Yang Ming Chiao Tung University
Taipei, 112
Yea-Ru Yang, PhD, 886228267279, yryang@nycu.edu.tw
About this study
Official title: 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.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease; Transcranial magnetic stimulation; Motor cortex; Corticomotor inhibition; Balance performance
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracortical inhibition
Short-interval intracortical inhibition assessed by transcranial magnetic stimulation
Measured: 20 minutes
Corticospinal inhibition
Cortical silent period assessed by transcranial magnetic stimulation
Measured: 20 minutes
Static balance
Sharpened Romberg test
Measured: 3 minutes
Dynamic balance
Functional reach test
Measured: 5 minutes
Functional balance
Mini-Balance Evaluation Systems Test
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start8 Oct 2021 (estimated)
- Primary completion8 Sep 2022 (estimated)
- Study completion8 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066659
- Sponsor's protocol ID
- YM110122F
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Balance Performance and Corticomotor Inhibition in Individuals With Parkinsons' Disease
- ClinicalTrials.gov ID
- NCT05066659
- Acronym / sponsor ID
- YM110122F
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's disease; Transcranial magnetic stimulation; Motor cortex; Corticomotor inhibition; Balance performance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 8 Oct 2021 (estimated)
- Primary completion
- 8 Sep 2022 (estimated)
- Study completion
- 8 Sep 2022 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- people with Parkinson's disease
Key inclusion criteria (3 listed)
- the Hoehn and Yahr stage between 1 and 3
- age 40 to 80 years
- a stable treatment of anti-PD medications
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intracortical inhibition
Time frame: 20 minutes
Short-interval intracortical inhibition assessed by transcranial magnetic stimulation
Corticospinal inhibition
Time frame: 20 minutes
Cortical silent period assessed by transcranial magnetic stimulation
Static balance
Time frame: 3 minutes
Sharpened Romberg test
Dynamic balance
Time frame: 5 minutes
Functional reach test
Functional balance
Time frame: 15 minutes
Mini-Balance Evaluation Systems Test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yea-Ru Yang, PhD (886228267279, yryang@nycu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracortical inhibition (time frame: 20 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2021.