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

NCT06994728 | Recruiting FDA Device

• 1 other identifier: Pro00136448
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Freezing of gait; Subthalamic nucleus; Visuospatial attention; Deep brain stimulation

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Investigators hypothesize that right STN stimulation induced improvement in attention will be associated with improvement in FOG.

  1 hour

Secondary Outcomes (2)

• Determine if there is a correlation between the change in Flanker task due to lateralized STN DBS stimulation in Parkinson's disease

  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

  30 minutes

Study Arms (2)

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

ACTIVE COMPARATOR

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.

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

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

ACTIVE COMPARATOR

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.

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

Interventions

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

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

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nathan DeTurk, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathan DeTurk, MD

CONTACT

843-792-3221; deturk@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Investigator will not be blinded as they will need to make adjustments to patient deep brain stimulation settings during testing.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to 2 groups which will determine the side of stimulation that is kept on first while cognitive tests and assessments for freezing of gait are performed. Patients will then complete the same testing on the contralateral side.

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: May 29, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)