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

NCT ID: NCT04147377

Last Updated: 2019-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD with FOG

Patients with Parkinson's disease who complain of freezing of gait

Group Type EXPERIMENTAL

behavioral intervention based on sensory cues

Intervention Type BEHAVIORAL

Patients will receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice.

Interventions

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behavioral 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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BS Jeon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Beomseok Jeon, Professor

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Central Contacts

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Beomseok Jeon, Professor

Role: CONTACT

Phone: +82-2-2072-2876

Email: [email protected]

Other Identifiers

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H-1910-104-1071

Identifier Type: -

Identifier Source: org_study_id