Parkinson DiseaseNCT06911229
Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease
A study testing Deep Brain Stimulation (DBS) in people with Parkinson Disease, run by University of Florida at 1 site in United States.
Trial summary
Locomotor adaptation will be studied using an established split-belt treadmill paradigm, consisting of baseline (1:1 speed ratio), split-belt adaptation (2:1) and post-adaptation (1:1) walking. Split-belt walking will be performed under DBS ON and DBS OFF conditions, while off-medication. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Deep Brain Stimulation (DBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Jul 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consensus diagnosis of idiopathic PD by fellowship trained movement disorders neurologists at the Normal Fixel Institute of Neurological Diseases;
- chronically stable DBS, defined as having had DBS for at least 6 months in duration with optimized DBS settings;
- Age between 18 - 80 years old per the FDA data sheet for PD DBS;
- no dementia according to the clinical diagnostic criteria for PD dementia;
- ambulatory without the use of walking aids, or another person's assistance.
Who cannot join
- other previous neurological surgery;
- suspicion of other neurologic diagnoses such as atypical parkinsonism, or Alzheimer's disease.
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
University of Florida
Gainesville, Florida, 32611
Julia Choi
About this study
Locomotor adaptation will be studied using an established split-belt treadmill paradigm, consisting of baseline (1:1 speed ratio), split-belt adaptation (2:1) and post-adaptation (1:1) walking. Split-belt walking will be performed under DBS ON and DBS OFF conditions, while off-medication.
Read the detailed description
We will test the hypotheses that DBS can facilitate split-belt walking adaptation with DBS ON compared with DBS OFF.
- Conditions
- Parkinson Disease
- Being tested
- Deep Brain Stimulation (DBS)
- Keywords
- Freezing of gait, deep brain stimulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation (DBS)Device
Patients will receive DBS in the clinically-optimized setting.
| Study group | Role | What they receive |
|---|---|---|
| DBS ON | Active comparator | DBS will be turned on Receives: Device: Deep Brain Stimulation (DBS) |
| DBS OFF | No intervention | DBS will be turned off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length rate of adaptation
The rate of adaptation in step length asymmetry is estimated by fitting an exponential decay function to step length asymmetry over the first 100 strides in adaptation.
Measured: 1 hour
Step length magnitude of adaptation
The magnitude of adaptation in step length asymmetry is calculated as the mean difference in step length asymmetry between early and late adaptation.
Measured: 1 hour
Step length after-effects
The after-effect in step length asymmetry is calculated as the mean difference in step length asymmetry between baseline and early post-adaptation.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Oct 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 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 University of FloridaThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911229
- Sponsor's protocol ID
- IRB202401786
- Other IDs
- R21AG088600
- Status last verified
- Aug 2025
- First submitted
- 28 Mar 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiology of Locomotor Adaptation and Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06911229
- Acronym / sponsor ID
- IRB202401786
- Conditions
- Parkinson Disease
- Keywords
- Freezing of gait, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 4 Apr 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.
Locomotor adaptation will be studied using an established split-belt treadmill paradigm, consisting of baseline (1:1 speed ratio), split-belt adaptation (2:1) and post-adaptation (1:1) walking. Split-belt walking will be performed under DBS ON and DBS OFF conditions, while off-medication.
Detailed description
We will test the hypotheses that DBS can facilitate split-belt walking adaptation with DBS ON compared with DBS OFF.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DBS ON | Active comparator | Device: Deep Brain Stimulation (DBS)DBS will be turned on |
| DBS OFF | No intervention | –DBS will be turned off |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- consensus diagnosis of idiopathic PD by fellowship trained movement disorders neurologists at the Normal Fixel Institute of Neurological Diseases;
- chronically stable DBS, defined as having had DBS for at least 6 months in duration with optimized DBS settings;
- Age between 18 - 80 years old per the FDA data sheet for PD DBS;
- no dementia according to the clinical diagnostic criteria for PD dementia;
- ambulatory without the use of walking aids, or another person's assistance.
Key exclusion criteria (2 listed)
- other previous neurological surgery;
- suspicion of other neurologic diagnoses such as atypical parkinsonism, or Alzheimer's disease.
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 |
|---|---|---|
| Deep Brain Stimulation (DBS)Patients will receive DBS in the clinically-optimized setting. | Device | DBS ON |
Primary outcome
Step length rate of adaptation
Time frame: 1 hour
The rate of adaptation in step length asymmetry is estimated by fitting an exponential decay function to step length asymmetry over the first 100 strides in adaptation.
Step length magnitude of adaptation
Time frame: 1 hour
The magnitude of adaptation in step length asymmetry is calculated as the mean difference in step length asymmetry between early and late adaptation.
Step length after-effects
Time frame: 1 hour
The after-effect in step length asymmetry is calculated as the mean difference in step length asymmetry between baseline and early post-adaptation.
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 15 Jul 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation (DBS) in people with Parkinson Disease, run by University of Florida 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 5 inclusion and 2 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 15 Jul 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 Julia Choi, Ph.D. (3522941720, juliachoi@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step length rate of adaptation (time frame: 1 hour). The study lists 3 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 15 Jul 2026.