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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04147377
Enrollment
60
Registered
2019-11-01
Start date
2020-01-01
Completion date
2020-12-31
Last updated
2019-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson's disease, Freezing of gait, visual cue, auditory cue, subthalamic nucleus, deep brain stimulation

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.

Interventions

BEHAVIORALbehavioral 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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)baseline, after 4 weeksThe 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 fallingbaseline, after 4 weeksWe will ask about the average number of falling over the last week at baseline and at 4-week f/u.

Secondary

MeasureTime frameDescription
Change from baseline to 4-week f/u in FOG-Q total scorebaseline, after 4 weeksThe 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-Qbaseline, after 2 weeksThe 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 fallingbaseline, after 2 weeksWe 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 subscore (Q4+Q5+Q6)baseline, after 2 weeksThe FOG-Q will be used to determine the efficacy of behavior intervention based on sensory cues.

Contacts

Primary ContactBeomseok Jeon, Professor
brain@snu.ac.kr+82-2-2072-2876

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026