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

NCT04147377 | Unknown

• 1 other identifier: H-1910-104-1071
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Change from baseline to 4-week f/u in FOG-Q subscore (Q4+Q5+Q6)

  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

  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 Outcomes (4)

• Change from baseline to 4-week f/u in FOG-Q total score

  baseline, after 4 weeks

• Change from baseline to 2-week f/u in FOG-Q

  baseline, after 2 weeks

• Change from baseline to 2-week f/u in the number of falling

  baseline, after 2 weeks

• Change from baseline to 2-week f/u in FOG-Q subscore (Q4+Q5+Q6)

  baseline, after 2 weeks

Study Arms (1)

PD with FOG

EXPERIMENTAL

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

Behavioral: behavioral intervention based on sensory cues

Interventions

behavioral intervention based on sensory cues BEHAVIORAL

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

PD with FOG

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Beomseok Jeon, Professor

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beomseok Jeon, Professor

CONTACT

+82-2-2072-2876; brain@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: January 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share