Clinical trial NCT04147377: Effects of Behavioral Interventions Based on Sensory Cues on FOG in PD After STN-DBS
Official title: Effects of Behavioral Interventions Based on Sensory Cues on Freezing of Gait in Parkinson's Disease After Subthalamic Nucleus Stimulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
Freezing of gait
visual cue
auditory cue
subthalamic nucleus
deep brain stimulation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)
timeFrame: baseline, after 4 weeks
measure: Change from baseline to 4-week f/u in the number of falling
timeFrame: baseline, after 4 weeks
Secondary outcomes:
measure: Change from baseline to 4-week f/u in FOG-Q total score
timeFrame: baseline, after 4 weeks
measure: Change from baseline to 2-week f/u in FOG-Q
timeFrame: baseline, after 2 weeks
measure: Change from baseline to 2-week f/u in the number of falling
timeFrame: baseline, after 2 weeks
measure: Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)
timeFrame: baseline, after 2 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Beomseok Jeon, Professor
role: PRINCIPAL_INVESTIGATOR
References: