Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Left STN-DBS on, right STN-DBS off first, Right STN-DBS on, left STN-DBS off first.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Gait Disorders, Neurologic, Visuospatial/Perceptual Abilities. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterization of Subthalamic Nucleus Deep Brain Stimulation Laterality on Visuospatial Attention and Correlation to Freezing of Gait in Parkinson's Disease
Overview
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.
Detailed description
FOG is a common and frequently disabling symptom of PD, affecting more than half of all PwPD. It remains a complex and incompletely understood phenomenon, with no currently approved therapies. FOG is often exacerbated during dual-tasks where attention is divided to multiple tasks. A well known method of provoking FOG by PwPD and neurologists alike is to walk through doorways or through a crowded space, regions where spatial attention is necessary. Similarly, significant visuospatial attention deficits have been found in PwPD who freeze compared to those do not. Further evidence demonstrates that the STN is part of the circuit which modulates spatial attention, and that STN-DBS has a significant impact on visuospatial attention and is notably improved with right sided stimulation. Indeed, visuospatial attention is largely considered to be predominantly lateralized to the right hemisphere. Interestingly, one study showed that right STN-DBS stimulation affecting a volume of activated tissue (VAT) connected to the right sensorimotor cortex showed a significant association with reduction in FOG. The impact of STN-DBS on visuospatial attention and the degree to which this change in attention is associated with changes in FOG has not yet been studied, and may well explain part of the pathophysiology of FOG and how to treat PwPD who freeze. The present study will build on the aforementioned research by prospectively evaluating the impact of lateralized STN-DBS stimulation on visuospatial attention in PwPD, and correlating this with change in FOG.
Interventions
- Device Left STN-DBS on, right STN-DBS off first
There 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. - Device Right STN-DBS on, left STN-DBS off first
There 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.
Primary outcome measures
- Characterize the individual impact of lateralized STN DBS stimulation on freezing of gait in Parkinson's disease [Time frame: 1 hour]
- 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 [Time frame: 1 hour]
Secondary outcome measures (2)
- Determine if there is a correlation between the change in Flanker task due to lateralized STN DBS stimulation in Parkinson's disease [Time frame: 30 minutes]
- Determine if there is a correlation between the change in Go-No-Go task due to lateralized STN DBS stimulation in Parkinson's disease [Time frame: 30 minutes]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Medical University of South Carolina — Charleston
Identifiers
NCT: NCT06994728 · Pro00136448