Understand FoG in PD: Behavioral Physiology and Clinical Application

NCT02987140 | Unknown

• 1 other identifier: 201606057RINA
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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). More specifically, we aim to determine the behavioral changes in context-dependency and changes in corticomotor excitability associated with FoG.

Conditions

Parkinson Disease; Freezing of Gait

Keywords

Parkinson's disease; freezing of gait; context-dependency; transcranial magnetic stimulation; visual cues

Outcome Measures

Primary Outcomes (2)

• 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).

  30 mins

• 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.

  40 mins

Secondary Outcomes (9)

• The Unified Parkinson's Disease Rating Scale (UPDRS)

  30 mins

• Montreal Cognitive Assessment (MoCA)

  10 mins

• The Stroop Color-Word test

  5 mins

• 10-Meter Walk Test (10MWT)

  5 mins

• The Timed Up and Go (TUG) test

  5 mins

Study Arms (3)

PD+FoG

EXPERIMENTAL

PD patients with FoG

Behavioral: Clinical evaluations

PD-FoG

ACTIVE COMPARATOR

PD patients without FoG

Behavioral: Clinical evaluations

Control

ACTIVE COMPARATOR

age-matched non-disabled adults

Behavioral: Clinical evaluations

Interventions

Clinical evaluations BEHAVIORAL

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.

Control; PD+FoG; PD-FoG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with Parkinson's disease
• Healthy control subjects

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ya-Yun Lee, PHD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ya-Yun Lee, PHD

CONTACT

886-2-33668155; yayunlee@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

TW (1)