Parkinson DiseaseNCT06994728
Correlation of STN-DBS Induced Visuospatial Changes and Freezing of Gait
A study testing Left STN-DBS on, right STN-DBS off first and Right STN-DBS on, left STN-DBS off first in people with Parkinson Disease and Gait Disorders, Neurologic, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic, Visuospatial/Perceptual Abilities
- What is being tested?
- Left STN-DBS on, right STN-DBS off first and Right STN-DBS on, left STN-DBS off first
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29403
Nathan DeTurk, MD, MBA, 843-792-3221, deturk@musc.edu
Nathan DeTurk, MD, MBA
About this study
Official title: Characterization of Subthalamic Nucleus Deep Brain Stimulation Laterality on Visuospatial Attention and Correlation to Freezing of Gait in Parkinson's Disease
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.
Read the 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.
- Being tested
- Left STN-DBS on, right STN-DBS off first, Right STN-DBS on, left STN-DBS off first
- Keywords
- Freezing of gait, Subthalamic nucleus, Visuospatial attention, Deep brain stimulation
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left STN-DBS on, right STN-DBS off firstDevice
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 firstDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Right STN-DBS on, left STN-DBS off first |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Apr 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nathan DeTurk, Medical University of South Carolina
- Investigators
- Nathan DeTurk, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994728
- Sponsor's protocol ID
- Pro00136448
- Status last verified
- Aug 2026
- First submitted
- 20 Jun 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Subthalamic Nucleus Deep Brain Stimulation Laterality on Visuospatial Attention and Correlation to Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06994728
- Acronym / sponsor ID
- Pro00136448
- Keywords
- Freezing of gait, Subthalamic nucleus, Visuospatial attention, Deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Left STN-DBS on, right STN-DBS off first | Active comparator | Device: Left STN-DBS on, right STN-DBS off firstSTN-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. |
| Right STN-DBS on, left STN-DBS off first | Active comparator | Device: Right STN-DBS on, left STN-DBS off firstSTN-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left STN-DBS on, right STN-DBS off firstThere 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 | Left STN-DBS on, right STN-DBS off first |
| Right STN-DBS on, left STN-DBS off firstThere 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 |
Primary outcome
Characterize the individual impact of lateralized STN DBS stimulation on freezing of gait in Parkinson's disease
Time frame: 1 hour
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.
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
Investigators hypothesize that right STN stimulation induced improvement in attention will be associated with improvement in FOG.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nathan DeTurk, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Left STN-DBS on, right STN-DBS off first and Right STN-DBS on, left STN-DBS off first in people with Parkinson Disease and Gait Disorders, Neurologic, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathan DeTurk, MD (843-792-3221, deturk@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the individual impact of lateralized STN DBS stimulation on freezing of gait in Parkinson's disease (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.