- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04147377
Effects of Behavioral Interventions Based on Sensory Cues on FOG in PD After STN-DBS
Effects of Behavioral Interventions Based on Sensory Cues on Freezing of Gait in Parkinson's Disease After Subthalamic Nucleus Stimulation
Study Overview
Status
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beomseok Jeon, Professor
- Phone Number: +82-2-2072-2876
- Email: brain@snu.ac.kr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
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
Investigators
- Principal Investigator: Beomseok Jeon, Professor, Seoul National University Hospital
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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