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

Not Applicable

• Conditions: Parkinson Disease
• Interventions: Behavioral: behavioral intervention based on sensory cues

• Registration Number: NCT04147377
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-11-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-16
• Last Update Posted: 2019-12-18
• Study Start: 2020-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PD with FOG	behavioral intervention based on sensory cues	Patients with Parkinson's disease who complain of freezing of gait

Primary Outcome Measures

Name	Time	Method
Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)	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	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 Outcome Measures

Name	Time	Method
Change from baseline to 4-week f/u in FOG-Q total score	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 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)	baseline, after 2 weeks	The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.
Change from baseline to 2-week f/u in the number of falling	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.
Change from baseline to 2-week f/u in FOG-Q	baseline, after 2 weeks	The FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.