Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
The purpose of this research is to determine how deep brain stimulation (DBS) for Parkinson's disease affects attention and visuospatial function. Additionally, this study will evaluate how deficits in visual attention are associated with freezing of gait (FOG) in Parkinson's disease. There is currently no reliable treatment for FOG and little is understood about the underlying reason this occurs. Some recent research has found that stimulating the right side of the brain seems to improve FOG. The right side of the brain is also paramount for visual attention, which is why investigators are conducting this study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects above 18 years of age
Subjects with freezing of gait
Subjects with bilateral STN-DBS surgery as part of their clinical care for Parkinson's disease
Disqualifiers
Uncorrected visual or hearing impairments, as indicated by self-report
Individuals who are pregnant or expect to become pregnant during the course of the study
Individuals with dementia or relevant brain lesions impacting cognition or gait
Trial design
Design model
Crossover
Treatments tested in this trial
Left STN-DBS on, right STN-DBS off first
DeviceThere will not be any change to baseline DBS stimulation settings, only each side will be sequentially turned off during cognitive and freezing of gait assessments.
Right STN-DBS on, left STN-DBS off first
DeviceThere will not be any change to baseline DBS stimulation settings, only each side will be sequentially turned off during cognitive and freezing of gait assessments.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Left STN-DBS on, right STN-DBS off firstActive comparator 1 intervention
Group B: Right STN-DBS on, left STN-DBS off firstActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Characterize the individual impact of lateralized STN DBS stimulation on freezing of gait in Parkinson's disease
Investigators hypothesize that right STN stimulation will have a significant association with reduction in freezing of gait, as measured by timed up and go task, compared to left STN stimulation and no stimulation.
Time frame
1 hour2
Determine if there is a correlation between the change in visuospatial function due to lateralized STN DBS stimulation and change in freezing of gait (FOG) in Parkinson's disease
Investigators hypothesize that right STN stimulation induced improvement in attention will be associated with improvement in FOG.
Time frame
1 hourSecondary outcomes
1
Determine if there is a correlation between the change in Flanker task due to lateralized STN DBS stimulation in Parkinson's disease
Investigators hypothesize that right STN stimulation will have a significant association with change in attention, as measured by the flanker task, compared to left STN stimulation and no stimulation.
Time frame
30 minutes2
Determine if there is a correlation between the change in Go-No-Go task due to lateralized STN DBS stimulation in Parkinson's disease
Investigators hypothesize that right STN stimulation will have a significant association with change in attention, as measured by the Go-No-Go task, compared to left STN stimulation and no stimulation
Time frame
30 minutesSponsors and contacts
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Source ClinicalTrials.gov