Parkinson's Disease (PD)NCT07348705
Electrophysiology-based DBS Programming for PD
A study testing Clinician-based DBS programming, Maximum Beta power-based DBS programming and Broad-band electrophysiology-based DBS programming in people with Parkinson's Disease (PD), run by University of Florida at 1 site in United States.
Trial summary
Deep brain stimulation (DBS) effectively alleviates motor symptoms in Parkinson's disease (PD). However, current programming is manual and time-consuming. This study will evaluate physiology-based programming using local field potentials (LFPs) to identify optimal stimulation parameters. Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Clinician-based DBS programming, Maximum Beta power-based DBS programming and Broad-band electrophysiology-based DBS programming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 15 Jan 2031
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of idiopathic PD fulfilling the Movement Disorder Society Clinical Diagnostic Criteria for PD
- DBS implantation with the Percept DBS device (Medtronic, USA) for the treatment of motor symptoms
- Ability to give informed consent for the study
- Willingness to do this study at the time of the initial programming session
- Age 21 to 89 years old
Who cannot join
- Inability to comply with the study protocol
- Atypical Parkinsonism
- Any personality or mood symptoms that study personnel believe will interfere with the study requirements
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
Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
Hikaru Kamo, MD, PhD, Hikaru.Kamo@neurology.ufl.edu
Julia C Gonzalez, BA, Julia.Gonzalez@neurology.ufl.edu
About this study
Official title: Electrophysiology-based Deep Brain Stimulation Programming for Parkinson's Disease
Deep brain stimulation (DBS) effectively alleviates motor symptoms in Parkinson's disease (PD). However, current programming is manual and time-consuming. This study will evaluate physiology-based programming using local field potentials (LFPs) to identify optimal stimulation parameters. Specifically, DBS contact selection based on beta power and a broad-band approach will be compared with conventional clinician-based programming.
Read the detailed description
Up to thirty patients with DBS (unilateral or bilateral leads) attached to a bidirectional implantable pulse generator will be enrolled in this study. This commercially available IPG allows both therapeutic stimulation and chronic sensing. It has been designed to capture local field potentials (LFPs) from implanted DBS leads while delivering stimulation both inside and outside the clinic.
After recording LFP data, then, the physician will perform the traditional clinical monopolar review and determine the optimized DBS settings ('clinician-based' settings) following standard clinical procedures, and without looking at the physiology data. In parallel, the LFP data will be analyzed to identify the 'optimal' therapy contact based on 1) maximum beta power, and 2 ) broad-band multi-frequency analysis.
The physician will then setup up to 4 stimulation programs will be set up:
- Clinician-based programming (standard of care),
- Maximum Beta power-based programming,
- Broad-band programming.
- If needed, second-best clinician-based programming (standard of care)
In this study, settings 1, 2, and 4 (optional) are determined based on established standards of care or manufacturer guidelines. Setting 3, however, is derived using our novel electrophysiology-based algorithm. While the method for determining this setting is innovative, the resulting parameter may be identical to those obtained through conventional approaches (settings 1, 2, or 4). Therefore, although the methodology introduces a new process, the final settings remain within clinically accepted ranges and do not exceed standard clinician-based practices.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Clinician-based DBS programming, Maximum Beta power-based DBS programming, Broad-band electrophysiology-based DBS programming
- Keywords
- deep brain stimulation, DBS, PD, Parkinson's disease, beta power
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinician-based DBS programmingDevice
Contacts, amplitude, pulse width, and frequency are chosen by the treating physician during a conventional monopolar review.
Maximum Beta power-based DBS programmingDevice
The contact that shows the strongest beta activity (13-30 Hz) in the local field potentials is selected for stimulation.
Broad-band electrophysiology-based DBS programmingDevice
A multi-frequency algorithm that integrates beta, theta/alpha, finely tuned gamma, and other relevant bands is used to identify the optimal contact.
| Study group | Role | What they receive |
|---|---|---|
| Clinician-based | Active comparator | Not described Receives: Device: Clinician-based DBS programming |
| Maximum beta power-based | Active comparator | Not described Receives: Device: Maximum Beta power-based DBS programming |
| Broad-band | Experimental | Not described Receives: Device: Broad-band electrophysiology-based DBS programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS)
The UPDRS (Unified Parkinson's Disease Rating Scale) Motor Scale (Part III) is a clinician-rated tool assessing motor functions like tremor, rigidity, bradykinesia, and gait in Parkinson's disease (PD), using a 0-4 scale for each item, with higher scores indicating greater impairment, helping track disease progression and treatment response.
Measured: From enrollment to end of study (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start15 Jan 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joshua Wong, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348705
- Sponsor's protocol ID
- IRB202500821
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiology-based Deep Brain Stimulation Programming for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07348705
- Acronym / sponsor ID
- IRB202500821
- Conditions
- Parkinson's Disease (PD)
- Keywords
- deep brain stimulation, DBS, PD, Parkinson's disease, beta power
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2031 (estimated)
- First posted
- 16 Jan 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.
Deep brain stimulation (DBS) effectively alleviates motor symptoms in Parkinson's disease (PD). However, current programming is manual and time-consuming. This study will evaluate physiology-based programming using local field potentials (LFPs) to identify optimal stimulation parameters. Specifically, DBS contact selection based on beta power and a broad-band approach will be compared with conventional clinician-based programming.
Detailed description
Up to thirty patients with DBS (unilateral or bilateral leads) attached to a bidirectional implantable pulse generator will be enrolled in this study. This commercially available IPG allows both therapeutic stimulation and chronic sensing. It has been designed to capture local field potentials (LFPs) from implanted DBS leads while delivering stimulation both inside and outside the clinic.
After recording LFP data, then, the physician will perform the traditional clinical monopolar review and determine the optimized DBS settings ('clinician-based' settings) following standard clinical procedures, and without looking at the physiology data. In parallel, the LFP data will be analyzed to identify the 'optimal' therapy contact based on 1) maximum beta power, and 2 ) broad-band multi-frequency analysis.
The physician will then setup up to 4 stimulation programs will be set up:
- Clinician-based programming (standard of care),
- Maximum Beta power-based programming,
- Broad-band programming.
- If needed, second-best clinician-based programming (standard of care)
In this study, settings 1, 2, and 4 (optional) are determined based on established standards of care or manufacturer guidelines. Setting 3, however, is derived using our novel electrophysiology-based algorithm. While the method for determining this setting is innovative, the resulting parameter may be identical to those obtained through conventional approaches (settings 1, 2, or 4). Therefore, although the methodology introduces a new process, the final settings remain within clinically accepted ranges and do not exceed standard clinician-based practices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinician-based | Active comparator | Device: Clinician-based DBS programming |
| Maximum beta power-based | Active comparator | Device: Maximum Beta power-based DBS programming |
| Broad-band | Experimental | Device: Broad-band electrophysiology-based DBS programming |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a diagnosis of idiopathic PD fulfilling the Movement Disorder Society Clinical Diagnostic Criteria for PD
- DBS implantation with the Percept DBS device (Medtronic, USA) for the treatment of motor symptoms
- Ability to give informed consent for the study
- Willingness to do this study at the time of the initial programming session
- Age 21 to 89 years old
Key exclusion criteria (3 listed)
- Inability to comply with the study protocol
- Atypical Parkinsonism
- Any personality or mood symptoms that study personnel believe will interfere with the study requirements
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 |
|---|---|---|
| Clinician-based DBS programmingContacts, amplitude, pulse width, and frequency are chosen by the treating physician during a conventional monopolar review. | Device | Clinician-based |
| Maximum Beta power-based DBS programmingThe contact that shows the strongest beta activity (13-30 Hz) in the local field potentials is selected for stimulation. | Device | Maximum beta power-based |
| Broad-band electrophysiology-based DBS programmingA multi-frequency algorithm that integrates beta, theta/alpha, finely tuned gamma, and other relevant bands is used to identify the optimal contact. | Device | Broad-band |
Primary outcome
Assessment of motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: From enrollment to end of study (1 month)
The UPDRS (Unified Parkinson's Disease Rating Scale) Motor Scale (Part III) is a clinician-rated tool assessing motor functions like tremor, rigidity, bradykinesia, and gait in Parkinson's disease (PD), using a 0-4 scale for each item, with higher scores indicating greater impairment, helping track disease progression and treatment response.
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 30 Mar 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.
Joshua Wong, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinician-based DBS programming, Maximum Beta power-based DBS programming and Broad-band electrophysiology-based DBS programming in people with Parkinson's Disease (PD), 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 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 30 Mar 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 Joshua Wong, MD (352-294-5400, Joshua.Wong@neurology.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS) (time frame: From enrollment to end of study (1 month)). 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 30 Mar 2026.