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

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Seoul National University

Status

Unknown

Conditions

Parkinson Disease

Treatments

Behavioral: behavioral intervention based on sensory cues

Study type

Interventional

Funder types

Other

Identifiers

NCT04147377
H-1910-104-1071

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

PD with FOG
Experimental group
Description:
Patients with Parkinson's disease who complain of freezing of gait
Treatment:
Behavioral: behavioral intervention based on sensory cues

Trial contacts and locations

0

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Central trial contact

Beomseok Jeon, Professor

Data sourced from clinicaltrials.gov

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