Parkinson DiseaseNCT07748962
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
A study testing Multiple Deep Brain Stimulation (DBS) Conditions, Moving Overground in a Virtual Environment (MOVE) and Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait) in people with Parkinson Disease and Freezing of Gait, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Freezing of Gait
- What is being tested?
- Multiple Deep Brain Stimulation (DBS) Conditions, Moving Overground in a Virtual Environment (MOVE) and Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2026to 18 Apr 2027
- 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
- You have been diagnosed with Parkinson's disease
- You already have a deep brain stimulation (DBS) device implanted as part of your medical care - specifically, the Medtronic Percept DBS device
- Your DBS settings have been stable for at least 3 months
- You experience freezing of gait (sudden inability to move your feet when trying to walk)
- You are able to walk on your own for at least 10 minutes without assistance
- You are willing to temporarily stop your Parkinson's medications and have your DBS settings adjusted for study testing
- You are able to understand the study and provide consent to participate
Who cannot join
- You have a neurological condition other than Parkinson's disease (such as stroke or multiple sclerosis)
- You have been diagnosed with dementia or have difficulty understanding the study or giving consent
- You currently have alcohol or substance abuse problems
- You have hearing or vision problems that would make it difficult to use a virtual reality headset
- You have any medical or mental health condition that, in the opinion of the study doctor, would make it unsafe or difficult for you to participate
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
Cleveland Clinic
Cleveland, Ohio, 44195
MacKenzie Dunlap, 216-219-3949, dunlapm4@ccf.org
Jay L Alberts, PhD
About this study
The purpose of this study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms.
Read the detailed description
PD is a progressive neurodegenerative disorder characterized by motor symptoms including tremor, rigidity, and bradykinesia. While DBS is an effective treatment for many of these motor symptoms, postural instability and gait dysfunction (PIGD), including FOG, frequently persist and are a major source of falls, loss of independence, and reduced quality of life.
The neural mechanisms underlying PIGD and FOG remain poorly understood, particularly in real-world conditions where these symptoms are most likely to occur. Conventional clinical assessments often fail to reliably provoke these gait disturbances, limiting the ability to study their underlying neurophysiology. At the same time, recent advances in DBS technology - specifically systems capable of recording brain signals, or neural activity - provide a unique opportunity to directly examine brain signals associated with gait impairment.
This study is designed to characterize the neural mechanisms associated with PIGD and FOG in individuals with PD who have an implanted sensing-enabled DBS system (Medtronic Percept™). By integrating neural recordings from the subthalamic nucleus (STN) with detailed biomechanical measurements during walking tasks, the study aims to identify patterns of neural activity that precede, accompany, and follow gait disturbances.
To address the challenge of eliciting ecologically valid gait disturbances, participants will complete walking and balance tasks within a fully immersive virtual reality platform. This system simulates real-world scenarios that are meant to provoke FOG and PIGD, including situations involving environmental constraints, anxiety-inducing contexts, and dual-task cognitive demands.
Additional assessments will include stair ambulation and functional mobility tasks using an instrumented gait platform which provides quantitative measures of temporal, kinematic, and kinetic aspects of walking and balance.
During these tasks, neural activity recorded from the DBS device will be synchronized with motion capture and biomechanical data. This integrated dataset will allow investigators to examine how neural activity relates to gait performance and to identify neural patterns associated with FOG episodes.
Participants will undergo multiple testing sessions under varying DBS conditions, including their clinically optimized DBS therapy and other programmed conditions. These comparisons will enable evaluation of how different stimulation approaches influence neural activity and gait performance.
The knowledge gained from this study is expected to advance understanding of the neural mechanisms underlying gait dysfunction in PD and may inform the development of more personalized and adaptive neuromodulation strategies to better treat these disabling symptoms in the future.
- Conditions
- Parkinson Disease, Freezing of Gait
- Being tested
- Multiple Deep Brain Stimulation (DBS) Conditions, Moving Overground in a Virtual Environment (MOVE), Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait)
- Keywords
- Deep brain stimulation, Balance, Postural instability, Gait dysfunction, Virtual reality, Mixed reality, Percept, Falls, Parkinson's disease, DBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Deep Brain Stimulation (DBS) ConditionsOther
Participants have the Medtronic Percept DBS system implanted as part of standard clinical care. During study sessions, stimulation is evaluated under different conditions, including clinically optimized stimulation, off stimulation, and alternative stimulation paradigms. Stimulation settings are temporarily adjusted for research assessments and are returned to clinically optimized settings at the end of each session. Effects of those conditions on task performance are being assessed.
Moving Overground in a Virtual Environment (MOVE)Behavioural
Participants complete walking and balance tasks within a virtual reality environment designed to simulate real-world situations that provoke gait disturbances. Tasks include navigating environmental constraints, performing turning and stopping movements, and completing dual-task cognitive challenges while walking.
Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait)Behavioural
Participants complete stair ambulation and functional mobility tasks on an instrumented platform, including ascending and descending steps, walking, turning, and performing dual-task conditions. These assessments provide quantitative measures of gait performance, balance, and functional mobility.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments | Experimental | All participants undergo repeated assessments under multiple deep brain stimulation (DBS) conditions in a randomized order. Each participant serves as their own control and completes testing under clinically optimized stimulation, as well as alternative stimulation paradigms. An additional baseline condition without stimulation is performed prior to randomized testing.
Assessments include walking and balance tasks performed in a virtual reality environment designed to simulate real-world gait challenges, as well as stair ambulation and functional mobility tasks. Neural activity is recorded from the implanted DBS device and synchronized with biomechanical and kinematic data collected during task performance. This design enables within-subject comparisons of neural activity and gait performance across stimulation conditions. Receives: Other: Multiple Deep Brain Stimulation (DBS) Conditions; Behavioral: Moving Overground in a Virtual Environment (MOVE); Behavioral: Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in STN-LFP power fluctuations from single-task walking compared to FOG episode
Participants will complete motor, cognitive and dual-task modules in a virtual reality environment that simulates a home-setting, allowing for acquisition of real-world, at-home behavior. They will also complete a stair navigation task under both single and dual-task conditions. During these assessments, neural activity (i.e., subthalamic nucleus local field potentials (STN-LFPs)) will be recorded from the Medtronic Percept Deep Brain Stimulation system. Freezing of gait (FOG) episodes will be marked by a clinician, and change in STN-LFP power fluctuations from single-task walking compared to FOG episodes will be analyzed as the primary outcome.
Measured: Five sessions completed from enrollment to the end of testing, over an average of one week.
Secondary outcomes (2)
Number of FOG episodes during the MOVE system modules under each of the four DBS conditions
Participants will complete motor, cognitive and dual-task modules in a virtual reality setting, Moving Overground in Virtual Environments (MOVE). The MOVE system simulates a home-setting, allowing for acquisition of real-world, at-home behavior. It consists of four modules: 1) Reference, 2) Physical, 3) Anxiety, 4) Cognitive (dual-task). Freezing of gait (FOG) episodes usually occur under stressful circumstances which can be grouped into three broad categories: changes in physical environment, anxiety-provoking situations and dual-task environments. The modules in the MOVE system are designed to elicit FOG episodes in a research setting. FOG episodes will be marked by a clinician, and the number of episodes under each of the four DBS conditions will be compared.
Measured: Five sessions completed from enrollment to the end of testing, over an average of one week.
Overall time for SAFE-Gait task
Participants will complete the Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait). The SAFE-Gait test requires participants to 1) ascend 3 standard steps, 2) walk on a flat surface for 3 meters, 3) turn and 4) walk back to the starting position which requires descending 3 steps. The time to complete this task will be recorded and compared for all tested DBS conditions.
Measured: Five sessions completed from enrollment to the end of testing, over an average of one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start9 Dec 2026 (estimated)
- Primary completion18 Mar 2027 (estimated)
- Study completion18 Apr 2027 (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 The Cleveland ClinicThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will complete all assessments and DBS conditions. They will first complete an ON medication/ON DBS session, followed by an OFF medication/OFF DBS session. The remaining 3 DBS testing conditions will be completed in a randomized order for each participant.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Jay Alberts, The Cleveland Clinic
- Investigators
- Jay L Alberts, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07748962
- Sponsor's protocol ID
- 26-526
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07748962
- Acronym / sponsor ID
- 26-526
- Conditions
- Parkinson Disease, Freezing of Gait
- Keywords
- Deep brain stimulation, Balance, Postural instability, Gait dysfunction, Virtual reality, Mixed reality, Percept, Falls
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 9 Dec 2026 (estimated)
- Primary completion
- 18 Mar 2027 (estimated)
- Study completion
- 18 Apr 2027 (estimated)
- First posted
- 6 Aug 2026 (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 study is to learn how brain signals are related to freezing of gait (FOG) and balance problems in Parkinson's disease (PD) and to study how different deep brain stimulation (DBS) settings may affect these symptoms.
Detailed description
PD is a progressive neurodegenerative disorder characterized by motor symptoms including tremor, rigidity, and bradykinesia. While DBS is an effective treatment for many of these motor symptoms, postural instability and gait dysfunction (PIGD), including FOG, frequently persist and are a major source of falls, loss of independence, and reduced quality of life.
The neural mechanisms underlying PIGD and FOG remain poorly understood, particularly in real-world conditions where these symptoms are most likely to occur. Conventional clinical assessments often fail to reliably provoke these gait disturbances, limiting the ability to study their underlying neurophysiology. At the same time, recent advances in DBS technology - specifically systems capable of recording brain signals, or neural activity - provide a unique opportunity to directly examine brain signals associated with gait impairment.
This study is designed to characterize the neural mechanisms associated with PIGD and FOG in individuals with PD who have an implanted sensing-enabled DBS system (Medtronic Percept™). By integrating neural recordings from the subthalamic nucleus (STN) with detailed biomechanical measurements during walking tasks, the study aims to identify patterns of neural activity that precede, accompany, and follow gait disturbances.
To address the challenge of eliciting ecologically valid gait disturbances, participants will complete walking and balance tasks within a fully immersive virtual reality platform. This system simulates real-world scenarios that are meant to provoke FOG and PIGD, including situations involving environmental constraints, anxiety-inducing contexts, and dual-task cognitive demands.
Additional assessments will include stair ambulation and functional mobility tasks using an instrumented gait platform which provides quantitative measures of temporal, kinematic, and kinetic aspects of walking and balance.
During these tasks, neural activity recorded from the DBS device will be synchronized with motion capture and biomechanical data. This integrated dataset will allow investigators to examine how neural activity relates to gait performance and to identify neural patterns associated with FOG episodes.
Participants will undergo multiple testing sessions under varying DBS conditions, including their clinically optimized DBS therapy and other programmed conditions. These comparisons will enable evaluation of how different stimulation approaches influence neural activity and gait performance.
The knowledge gained from this study is expected to advance understanding of the neural mechanisms underlying gait dysfunction in PD and may inform the development of more personalized and adaptive neuromodulation strategies to better treat these disabling symptoms in the future.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will complete all assessments and DBS conditions. They will first complete an ON medication/ON DBS session, followed by an OFF medication/OFF DBS session. The remaining 3 DBS testing conditions will be completed in a randomized order for each participant.
| Arm | Type | Receives |
|---|---|---|
| Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments | Experimental | Other: Multiple Deep Brain Stimulation (DBS) Conditions, Behavioral: Moving Overground in a Virtual Environment (MOVE), Behavioral: Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait)All participants undergo repeated assessments under multiple deep brain stimulation (DBS) conditions in a randomized order. Each participant serves as their own control and completes testing under clinically optimized stimulation, as well as alternative stimulation paradigms. An additional baseline condition without stimulation is performed prior to randomized testing. Assessments include walking and balance tasks performed in a virtual reality environment designed to simulate real-world gait challenges, as well as stair ambulation and functional mobility tasks. Neural activity is recorded from the implanted DBS device and synchronized with biomechanical and kinematic data collected during task performance. This design enables within-subject comparisons of neural activity and gait performance across stimulation conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- You have been diagnosed with Parkinson's disease
- You already have a deep brain stimulation (DBS) device implanted as part of your medical care - specifically, the Medtronic Percept DBS device
- Your DBS settings have been stable for at least 3 months
- You experience freezing of gait (sudden inability to move your feet when trying to walk)
- You are able to walk on your own for at least 10 minutes without assistance
Key exclusion criteria (5 listed)
- You have a neurological condition other than Parkinson's disease (such as stroke or multiple sclerosis)
- You have been diagnosed with dementia or have difficulty understanding the study or giving consent
- You currently have alcohol or substance abuse problems
- You have hearing or vision problems that would make it difficult to use a virtual reality headset
- You have any medical or mental health condition that, in the opinion of the study doctor, would make it unsafe or difficult for you to participate
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 |
|---|---|---|
| Multiple Deep Brain Stimulation (DBS) ConditionsParticipants have the Medtronic Percept DBS system implanted as part of standard clinical care. During study sessions, stimulation is evaluated under different conditions, including clinically optimized stimulation, off stimulation, and alternative stimulation paradigms. Stimulation settings are temporarily adjusted for research assessments and are returned to clinically optimized settings at the end of each session. Effects of those conditions on task performance are being assessed. | Other | Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments |
| Moving Overground in a Virtual Environment (MOVE)Participants complete walking and balance tasks within a virtual reality environment designed to simulate real-world situations that provoke gait disturbances. Tasks include navigating environmental constraints, performing turning and stopping movements, and completing dual-task cognitive challenges while walking. | Behavioural | Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments |
| Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait)Participants complete stair ambulation and functional mobility tasks on an instrumented platform, including ascending and descending steps, walking, turning, and performing dual-task conditions. These assessments provide quantitative measures of gait performance, balance, and functional mobility. | Behavioural | Participants With Parkinson Disease Undergoing Multi-Condition DBS Assessments |
Primary outcome
Change in STN-LFP power fluctuations from single-task walking compared to FOG episode
Time frame: Five sessions completed from enrollment to the end of testing, over an average of one week.
Participants will complete motor, cognitive and dual-task modules in a virtual reality environment that simulates a home-setting, allowing for acquisition of real-world, at-home behavior. They will also complete a stair navigation task under both single and dual-task conditions. During these assessments, neural activity (i.e., subthalamic nucleus local field potentials (STN-LFPs)) will be recorded from the Medtronic Percept Deep Brain Stimulation system. Freezing of gait (FOG) episodes will be marked by a clinician, and change in STN-LFP power fluctuations from single-task walking compared to FOG episodes will be analyzed as the primary outcome.
2 secondary outcomes
Number of FOG episodes during the MOVE system modules under each of the four DBS conditions
Time frame: Five sessions completed from enrollment to the end of testing, over an average of one week.
Overall time for SAFE-Gait task
Time frame: Five sessions completed from enrollment to the end of testing, over an average of one week.
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 26 Oct 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.
Jay L Alberts, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Deep Brain Stimulation (DBS) Conditions, Moving Overground in a Virtual Environment (MOVE) and Cleveland Clinic Stair Ambulation and Functional Evaluation of Gait (SAFE-Gait) in people with Parkinson Disease and Freezing of Gait, run by The Cleveland Clinic 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 7 inclusion and 5 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 26 Oct 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 MacKenzie Dunlap (216-219-3949, dunlapm4@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in STN-LFP power fluctuations from single-task walking compared to FOG episode (time frame: Five sessions completed from enrollment to the end of testing, over an average of one week.). 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 26 Oct 2026.