Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait

NCT ID: NCT06994728

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Parkinson Disease; Gait Disorders, Neurologic; Visuospatial/Perceptual Abilities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Left STN-DBS on, right STN-DBS off first

STN-DBS will be turned off sequentially for each side, in this group beginning with left STN-DBS on and right STN-DBS off. This will then be followed by the corollary.

Group Type: ACTIVE_COMPARATOR

Left STN-DBS on, right STN-DBS off first

Intervention Type: DEVICE

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.

Right STN-DBS on, left STN-DBS off first

STN-DBS will be turned off sequentially for each side, in this group beginning with right STN-DBS on and left STN-DBS off. This will then be followed by the corollary.

Group Type: ACTIVE_COMPARATOR

Right STN-DBS on, left STN-DBS off first

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan DeTurk, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nathan DeTurk, MD

Role: CONTACT

deturk@musc.edu

843-792-3221

Facility Contacts

Nathan DeTurk, MD, MBA

Role: primary

deturk@musc.edu

843-792-3221

Other Identifiers

Pro00136448

Identifier Type: -

Identifier Source: org_study_id