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Clinical Trials/NCT04147377
NCT04147377
Unknown
N/A

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

Seoul National University Hospital0 sites60 target enrollmentJanuary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Seoul National University Hospital
Enrollment
60
Primary Endpoint
Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
Last Updated
6 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

BS Jeon

Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • Change from baseline to 4-week f/u in FOG-Q total score(baseline, after 4 weeks)
  • Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)(baseline, after 2 weeks)
  • Change from baseline to 2-week f/u in the number of falling(baseline, after 2 weeks)
  • Change from baseline to 2-week f/u in FOG-Q(baseline, after 2 weeks)

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