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Parkinson DiseaseNCT02987140

Understand FoG in PD: Behavioral Physiology and Clinical Application

A study testing Clinical evaluations in people with Parkinson Disease and Freezing of Gait, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The overall goals of this proposed study are to investigate the behavioral and neurophysiological mechanisms of patients with Parkinson's disease (PD) experiencing freezing of gait (FoG). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Parkinson Disease, Freezing of Gait
What is being tested?
Clinical evaluations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTaiwan
Study dates
Dec 2016to Dec 2019
Phase
Interventional
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Individuals with Parkinson's disease
  • Healthy control subjects

Who cannot join

  • unable to follow the instructions
  • have other neurological diseases other than PD
  • have pacemaker implanted in their body
  • have a history of seizure
  • have a family history of epilepsy

Trial locations and contacts

1 site in 1 country.

Ya-Yun Lee, PHD contact

886-2-33668155

yayunlee@ntu.edu.tw

Taiwan1 site, 1 recruiting

  • National Taiwan University Hospital

    Taipei, 100

    Ya-Yun Lee, PHD, 02-33668155, yayunlee@ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: Understand Freezing of Gait in Parkinson's Disease: Behavioral Physiology and Clinical Application

The overall goals of this proposed study are to investigate the behavioral and neurophysiological mechanisms of patients with Parkinson's disease (PD) experiencing freezing of gait (FoG). More specifically, we aim to determine the behavioral changes in context-dependency and changes in corticomotor excitability associated with FoG.

Read the detailed description

Background: Freezing of gait (FoG) is a debilitating symptom for patients with Parkinson's disease (PD). FoG not only impairs walking but also significantly increase fall risks and decrease quality of life for patients with PD. Despite the critical consequences, the mechanisms associated with this phenomenon are not well understood.

Clinically, FoG often occurs when individuals with PD are approaching a narrow pathway or crossing a busy street. This observation leads to the hypothesis that FoG is associated with context-dependent motor performance, a phenomenon that an individual demonstrate poorer performance if the learned motor task is carried out in an unfamiliar context. Whether the occurrence of freezing episodes is a result of context-dependency has not been systematically investigated. Moreover, the changes in corticomotor excitability associated with FoG have not been well-established.

Objectives: The objectives of this proposal are to understand the behavioral and neurophysiological mechanisms of FoG. The specific aim is to examine the behavioral changes in context-dependency and changes in corticomotor excitability associated with FoG.

Methods: a total of 70 participants, including PD patients with FoG, PD patients without FoG, and age-matched non-disabled adults, will be recruited. The participants will undergo behavioral and neurophysiological examinations. Behavioral evaluations will include context-dependent motor performance, FoG, disease severity, and walking and balance functions. Transcranial magnetic stimulation and electroencephalogram will be used to measure corticomotor excitability of the participants. Analysis of variance (ANOVA) and regression analysis will be performed to compare and determine the relationship between FoG, behavioral outcomes, and corticomotor excitability. Statistical significance level is set at p < 0.05.

Being tested
Clinical evaluations
Keywords
Parkinson's disease, freezing of gait, context-dependency, transcranial magnetic stimulation, visual cues
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical evaluationsBehavioural

    Participants will receive clinical evaluations, and practice the finger sequence task used to assess context-dependency along with EEG assessment. On the second day, the participants will receive the TMS assessment.

Study groups in NCT02987140
Study groupRoleWhat they receive
PD+FoGExperimentalPD patients with FoG
Receives: Behavioral: Clinical evaluations
PD-FoGActive comparatorPD patients without FoG
Receives: Behavioral: Clinical evaluations
ControlActive comparatorage-matched non-disabled adults
Receives: Behavioral: Clinical evaluations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. New Freezing of Gait Questionnaire (NFOG-Q)

    The New Freezing of Gait Questionnaire (NFOG-Q) will be used to evaluate the freezing frequency and severity of the patients with PD. It composes of 3 parts; in the first part, a video clip will be shown to the participants with PD and help to classify whether an individual is a freezer or non-freezer. The second and third part of the questionnaire is designed for freezers only. PartⅡassesses the severity of FoG according to the frequency and duration of the freezing episodes, while PartⅢevaluates the impact of freezing on daily activities, such as walking. The reliability and internal consistency of the NFOG-Q have been well-established for patients with PD (Nieuwboer et al., 2009).

    Measured: 30 mins

  2. Context-dependent behavior

    A modified finger sequence task is specifically designed to evaluate context-dependent behavior for patients with PD. The participants will be instructed to put their index and middle fingers of both hands on a designated location of an enlarged key-board.

    The participants will first practice the three sequences for a total of 324 practice trials on the first day. Ten minutes and 24 hours after practice, to control for the medication status, the participants will be tested under the SAME and SWITCH conditions.With these 2 testing conditions, we will be able to calculate a variable called Switch Cost, which is the performance difference between the SWTICH and the SAME conditions normalized by the SAME condition [100% * (SWITCH - SAME)/SAME]. The Switch Cost will be used as an indicator of context-dependency.

    Measured: 40 mins

Secondary outcomes (9)

  1. The Unified Parkinson's Disease Rating Scale (UPDRS)

    The UPDRS contains 4 sections, and PartIIIwill be used in this study to evaluate the motor disturbances of patients with PD. Excellent internal consistency and validity has been established for UPDRS (Goetz et al., 2008).

    Measured: 30 mins

  2. Montreal Cognitive Assessment (MoCA)

    The MoCA evaluates several cognitive domains, including visuospatial processing, naming, short-term memory, digit forward and backward span, verbal fluency, abstract concept, counting, and orientation. The MoCA has been found to be a valid and reliable tool to screen for cognitive dysfunctions in patients with PD (Gill, Freshman, Blender, \& Ravina, 2008).

    Measured: 10 mins

  3. The Stroop Color-Word test

    The Stroop Color-Word test involves congruent and incongruent conditions.The goal of the participants is to read out the ink color of the word, but not the color word name itself, as accurately and as soon as possible (Dubois et al., 2007; Ridley, Johnson, \& Braisted, 1978).

    Measured: 5 mins

  4. 10-Meter Walk Test (10MWT)

    10MWT assesses the walking ability of the participants. The participants will be instructed to walk in their comfortable walking speed and their fastest walking speed for 10 meters. Gait speed, stride length, and cadence will be calculated.

    Measured: 5 mins

  5. The Timed Up and Go (TUG) test

    The TUG evaluates the balance ability of the participants. The participants will be seated on a comfortable chair with hip and knee flexed at 90 Upon a 'Go' signal, the participants will stand up from the chair, walk 3 meters, turn around, and sit back down to the chair. The time to complete the procedure will be measured.

    Measured: 5 mins

  6. The Parkinson's Disease Questionnaire(PDQ-39)

    The PDQ-39 specifically assess quality of life in patients with PD. PDQ-39 contains 39 questions embedded in 8 different domains. PDQ-39 has now become the most widely accepted and reliable measure to determine the overall health status for patients with PD (Jenkinson, Peto, Fitzpatrick, Greenhall, \& Hyman, 1995).

    Measured: 10 mins

  7. Transcranial magnetic stimulation

    To compare the neurophysiological characteristics of PD patients with FoG, PD patients without FoG, and non-disabled adults, a TMS device (The Magstim Company Ltd, Whitland, UK) will be used. TMS outcomes will include resting motor threshold (RMT), motor evoked potentials (MEPs), cortical silent period (CSP), short-interval intracortical inhibition (SICI), long-interval intracortical inhibition (LICI), and intracortical facilitation (ICF).

    Measured: 45 mins

  8. Electroencephalogram (EEG)

    While performing the modified finger sequence task, the electroencephalogram (EEG) will be used to monitor and record brain activity. Comparisons will be made between the first block of practice, last block of practice, and the two testing conditions.

    Measured: 40 mins

  9. The short FoG and festination assessment score

    The short FoG and festination assessment score, developed by Ziegler and colleagues (2010), will be used to clinically assess freezing and festination episodes over a short time course. The participants will initially sit on a chair for 30 seconds, then they will be instructed to stand up and walk to a floor mark with 40 radius and make 360 turn clockwise and counter-clockwise. Then, the participants will walk through a door, turn around and walk back to the chair. The participants will be required to walk in a fast but safe speed. This evaluation approach has been demonstrated to be feasible and reliable for assessing the severity of freezing and festination.

    Measured: 20 mins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionDec 2019 (estimated)
  4. Study completionDec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02987140
Sponsor's protocol ID
201606057RINA
Status last verified
Dec 2016
First submitted
6 Dec 2016
Last updated
8 Dec 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinical evaluations in people with Parkinson Disease and Freezing of Gait, run by National Taiwan University Hospital 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 2 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 8 Dec 2016. 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 Ya-Yun Lee, PHD (886-2-33668155, yayunlee@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New Freezing of Gait Questionnaire (NFOG-Q) (time frame: 30 mins). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02987140.

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 8 Dec 2016.

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