Effects of Behavioral Interventions Based on Sensory Cues on FOG in PD After STN-DBS

December 16, 2019 updated by: BS Jeon, Seoul National University Hospital

Effects of Behavioral Interventions Based on Sensory Cues on Freezing of Gait in Parkinson's Disease After Subthalamic Nucleus Stimulation

The investigators aims to assess the effectiveness of behavioral interventions based on sensory cues on freezing of gait in patients with Parkinson's disease after bilateral subthalamic nucleus deep brain stimulation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Freezing of gait (FOG) leads to falling and is one of the major determinants of quality of life and prognosis in Parkinson's disease (PD). Previous evidence suggests that subthalamic nucleus deep brain stimulation (STN-DBS) improve off-medication FOG but not on-medication FOG in patients with PD. Furthermore, off-mediation FOG persist or even worsen after STN-DBS in some PD patients.

Although visual and auditory cues are known to improve FOG in research setting, it is unclear whether these cues are effective for FOG in real clinical setting. Most previous studies have used wearable devices to use sensory cues, but such devices are difficult to apply in clinical practice.

Therefore, this study aims to investigate the effectiveness of behavioral interventions based on visual and auditory cues in patients with PD after bilateral STN-DBS. Participants undergo clinical evaluations including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Frontal Assessment Battery (FAB), Unified Parkinson 's Disease Rating Scale (UPDRS), Freezing of Gait-Questionnaire (FOG-Q), and the average number of falling over the last week. Then, participants receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice. To investigate the education effect, FOG-Q and the average number of falling over the last week are repetitively assessed at 2-week and 4-week follow-ups using a phone call.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

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

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

30 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with Parkinson's disease who are aged 30 years or older
  • Patients who underwent bilateral subthalamic nucleus deep brain stimulation
  • Patients who complain of freezing of gait

Exclusion Criteria:

  • Patients who have already used sensory cues for freezing of gait in clinical practice
  • Patients with MMSE scores of 18 or lower
  • Patients with Hoehn-Yahr scale 5
  • Patients who have neurological symptoms associated with neurological disorders other than Parkinson's disease

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

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PD with FOG
Patients with Parkinson's disease who complain of freezing of gait
Behavioral: behavioral intervention based on sensory cues
Patients will receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
Time Frame: baseline, after 4 weeks
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
baseline, after 4 weeks
Change from baseline to 4-week f/u in the number of falling
Time Frame: baseline, after 4 weeks
We will ask about the average number of falling over the last week at baseline and at 4-week f/u.
baseline, after 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to 4-week f/u in FOG-Q total score
Time Frame: baseline, after 4 weeks
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
baseline, after 4 weeks
Change from baseline to 2-week f/u in FOG-Q
Time Frame: baseline, after 2 weeks
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
baseline, after 2 weeks
Change from baseline to 2-week f/u in the number of falling
Time Frame: baseline, after 2 weeks
We will ask about the average number of falling over the last week at baseline and at 2-week f/u.
baseline, after 2 weeks
Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)
Time Frame: baseline, after 2 weeks
The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
baseline, after 2 weeks

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Beomseok Jeon, Professor, Seoul National University Hospital

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)

January 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (ACTUAL)

November 1, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 18, 2019

Last Update Submitted That Met QC Criteria

December 16, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1910-104-1071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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