Parkinson DiseaseNCT07410598
Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
A study testing Biphasic deep brain stimulation, Conventional deep brain stimulation and Theta burst deep brain stimulation in people with Parkinson Disease and Deep Brain Stimulation, run by University of Florida at 1 site in United States.
Trial summary
The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease, Deep Brain Stimulation
- What is being tested?
- Biphasic deep brain stimulation, Conventional deep brain stimulation and Theta burst deep brain stimulation
- 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
- 6 May 2026to 1 Mar 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System
- Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist
- Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months
Who cannot join
- History of previous neurosurgical intervention aside from DBS
- Diagnosis of dementia (whether primary or related to Parkinson's disease)
- A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation
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, 32608
Joshua Wong, MD, 352-294-5400, joshua.wong@neurology.ufl.edu
About this study
The primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.
Read the detailed description
This pilot study will investigate the safety, tolerability, and feasibility of three distinct patterned Deep Brain Stimulation (pDBS) paradigms delivered in a home setting using the Boston Scientific Chronos Research Engine. The three stimulation patterns under evaluation are:
- Biphasic DBS (bDBS)
- Nocturnal Theta Burst Stimulation (tDBS)
- Region-Specific Frequency Alternation (fDBS).
Sixty patients with Parkinson's Disease (PD), each with stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS for at least six months, will be enrolled and assigned to one of the three parallel study arms. At the baseline visit, each participant will be programmed with two stimulation settings: one replicating their chronic best clinical setting, and a second incorporating the assigned patterned stimulation.
For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing. In the tDBS arm, the second setting will deliver theta burst stimulation-six bursts per second at the therapeutic frequency-during nighttime hours, using the internal IPG clock to align with the participant's typical sleep schedule. For those in the fDBS arm, the second setting will apply high-frequency stimulation to dorsal contacts (Levels 3 or 4) and low-frequency stimulation (30-60 Hz) to ventral contacts (Levels 1 or 2), while maintaining all other clinical parameters.
Participants will be blinded to the identity of the two settings and will be able to switch between them using their patient programmer. The study will follow a randomized, blinded, two-period crossover design over a total duration of four weeks. During the first two weeks, participants will use one of the two programmed settings. At the end of this period, a telemedicine visit will be conducted to collect quality of life (QoL) questionnaires, related surveys, and a video-based modified MDS-UPDRS assessment. Participants will then switch to the alternate setting for the remaining two weeks. At the conclusion of the study, participants will return for an in-person research visit to complete the same assessments for the second setting. This design allows for within-subject comparison of conventional DBS and patterned DBS in a real-world, home-based environment, and will generate critical data to inform the design of a future large-scale trial.
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Being tested
- Biphasic deep brain stimulation, Conventional deep brain stimulation, Theta burst deep brain stimulation, Multi frequency deep brain stimulation
- Keywords
- Parkinson disease, PD, DBS, 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.
Biphasic deep brain stimulationDevice
Deep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially
Conventional deep brain stimulationDevice
Conventional deep brain stimulation programming that is currently FDA approved
Theta burst deep brain stimulationDevice
Deep brain stimulation using a conventional waveform but timed such that in the evening hours (based on device clock) the device will adjust stimulation to bursts of conventional stimulation at 6 per second
Multi frequency deep brain stimulationDevice
Deep brain stimulation using conventional waveforms but simultaneously delivering high frequency stimulation on the dorsal contacts of the DBS lead and low frequency stimulation on the ventral contacts of the DBS lead
| Study group | Role | What they receive |
|---|---|---|
| Biphasic DBS (bDBS) | Experimental | For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing. Receives: Device: Biphasic deep brain stimulation; Device: Conventional deep brain stimulation |
| Nocturnal Theta Burst Stimulation (tDBS) | Experimental | In the tDBS arm, the second setting will deliver theta burst stimulation-six bursts per second at the therapeutic frequency-during nighttime hours, using the internal IPG clock to align with the participant's typical sleep schedule Receives: Device: Conventional deep brain stimulation; Device: Theta burst deep brain stimulation |
| Region-Specific Frequency Alternation (fDBS) | Experimental | For those in the fDBS arm, the second setting will apply high-frequency stimulation to dorsal contacts (Levels 3 or 4) and low-frequency stimulation (30-60 Hz) to ventral contacts (Levels 1 or 2), while maintaining all other clinical parameters. Receives: Device: Conventional deep brain stimulation; Device: Multi frequency deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of patterned DBS
The primary endpoint of this study is the proportion of participants who are able to tolerate patterned DBS (pDBS) for the full two-week intervention period. Tolerability is defined as the ability to remain on the assigned pDBS setting without reverting to an alternative DBS configuration.
Measured: From enrollment to the end of novel waveform trial period at 2 weeks
Secondary outcomes (2)
Change in motor symptom severity
A comparison of the modified MDS-UPDRS between conventional and patterned waveform based on a video assessment
Measured: From enrollment to the end of study period at 4 weeks
Change in quality of life
A comparison of quality of life metrics through the Parkinson's Disease Questionnaire (PDQ-39) between conventional and patterned DBS
Measured: From enrollment to the end of the study period at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start6 May 2026
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410598
- Sponsor's protocol ID
- IRB202501673
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified primary and secondary outcome data
Publications
Horn MA, Gulberti A, Gulke E, Buhmann C, Gerloff C, Moll CKE, Hamel W, Volkmann J, Potter-Nerger M. A New Stimulation Mode for Deep Brain Stimulation in Parkinson's Disease: Theta Burst Stimulation. Mov Disord. 2020 Aug;35(8):1471-1475. doi: 10.1002/mds.28083. Epub 2020 May 1.
PubMed 32357269Wong JK, Hu W, Barmore R, Lopes J, Moore K, Legacy J, Tahafchi P, Jackson Z, Judy JW, Raike RS, Wang A, Tsuboi T, Okun MS, Almeida L. Safety and Tolerability of Burst-Cycling Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease. Front Hum Neurosci. 2021 Apr 26;15:651168. doi: 10.3389/fnhum.2021.651168. eCollection 2021.
PubMed 33981207Akbar U, Raike RS, Hack N, Hess CW, Skinner J, Martinez-Ramirez D, DeJesus S, Okun MS. Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses. Neuromodulation. 2016 Jun;19(4):343-56. doi: 10.1111/ner.12397. Epub 2016 Mar 22.
PubMed 27000764
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Tolerability of Patterned Stimulation for DBS in the Home Setting
- ClinicalTrials.gov ID
- NCT07410598
- Acronym / sponsor ID
- IRB202501673
- Conditions
- Parkinson Disease, Deep Brain Stimulation
- Keywords
- Parkinson disease, PD, DBS, deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 13 Feb 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 primary objective of the proposed pilot study is to assess the safety and tolerability of active patterned Deep Brain Stimulation (pDBS) when administered in a home setting for patients with Parkinson's disease (PD) who have had stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS.
Detailed description
This pilot study will investigate the safety, tolerability, and feasibility of three distinct patterned Deep Brain Stimulation (pDBS) paradigms delivered in a home setting using the Boston Scientific Chronos Research Engine. The three stimulation patterns under evaluation are:
- Biphasic DBS (bDBS)
- Nocturnal Theta Burst Stimulation (tDBS)
- Region-Specific Frequency Alternation (fDBS).
Sixty patients with Parkinson's Disease (PD), each with stable bilateral Subthalamic Nucleus (STN) and Globus Pallidus internus (GPi) DBS for at least six months, will be enrolled and assigned to one of the three parallel study arms. At the baseline visit, each participant will be programmed with two stimulation settings: one replicating their chronic best clinical setting, and a second incorporating the assigned patterned stimulation.
For participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing. In the tDBS arm, the second setting will deliver theta burst stimulation-six bursts per second at the therapeutic frequency-during nighttime hours, using the internal IPG clock to align with the participant's typical sleep schedule. For those in the fDBS arm, the second setting will apply high-frequency stimulation to dorsal contacts (Levels 3 or 4) and low-frequency stimulation (30-60 Hz) to ventral contacts (Levels 1 or 2), while maintaining all other clinical parameters.
Participants will be blinded to the identity of the two settings and will be able to switch between them using their patient programmer. The study will follow a randomized, blinded, two-period crossover design over a total duration of four weeks. During the first two weeks, participants will use one of the two programmed settings. At the end of this period, a telemedicine visit will be conducted to collect quality of life (QoL) questionnaires, related surveys, and a video-based modified MDS-UPDRS assessment. Participants will then switch to the alternate setting for the remaining two weeks. At the conclusion of the study, participants will return for an in-person research visit to complete the same assessments for the second setting. This design allows for within-subject comparison of conventional DBS and patterned DBS in a real-world, home-based environment, and will generate critical data to inform the design of a future large-scale trial.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Biphasic DBS (bDBS) | Experimental | Device: Biphasic deep brain stimulation, Device: Conventional deep brain stimulationFor participants in the bDBS arm, the second setting will mirror their clinical setting but use a biphasic waveform to ensure charge balancing. |
| Nocturnal Theta Burst Stimulation (tDBS) | Experimental | Device: Conventional deep brain stimulation, Device: Theta burst deep brain stimulationIn the tDBS arm, the second setting will deliver theta burst stimulation-six bursts per second at the therapeutic frequency-during nighttime hours, using the internal IPG clock to align with the participant's typical sleep schedule |
| Region-Specific Frequency Alternation (fDBS) | Experimental | Device: Conventional deep brain stimulation, Device: Multi frequency deep brain stimulationFor those in the fDBS arm, the second setting will apply high-frequency stimulation to dorsal contacts (Levels 3 or 4) and low-frequency stimulation (30-60 Hz) to ventral contacts (Levels 1 or 2), while maintaining all other clinical parameters. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Bilateral STN or GPi DBS with Boston Scientific Vercise Genus DBS System
- Diagnosis of Parkinson's disease as confirmed by a movement disorders fellowship trained neurologist
- Chronic stable DBS therapy, defined as having DBS therapy for at least 6 months
Key exclusion criteria (3 listed)
- History of previous neurosurgical intervention aside from DBS
- Diagnosis of dementia (whether primary or related to Parkinson's disease)
- A diagnosis of atypical parkinsonism or secondary parkinsonism at any time after DBS implantation
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 |
|---|---|---|
| Biphasic deep brain stimulationDeep brain stimulation using active recharge biphasic waveforms consisting of an equal anodic and cathodic pulse immediately delivered sequentially | Device | Biphasic DBS (bDBS) |
| Conventional deep brain stimulationConventional deep brain stimulation programming that is currently FDA approved | Device | Biphasic DBS (bDBS), Nocturnal Theta Burst Stimulation (tDBS), Region-Specific Frequency Alternation (fDBS) |
| Theta burst deep brain stimulationDeep brain stimulation using a conventional waveform but timed such that in the evening hours (based on device clock) the device will adjust stimulation to bursts of conventional stimulation at 6 per second | Device | Nocturnal Theta Burst Stimulation (tDBS) |
| Multi frequency deep brain stimulationDeep brain stimulation using conventional waveforms but simultaneously delivering high frequency stimulation on the dorsal contacts of the DBS lead and low frequency stimulation on the ventral contacts of the DBS lead | Device | Region-Specific Frequency Alternation (fDBS) |
Primary outcome
Tolerability of patterned DBS
Time frame: From enrollment to the end of novel waveform trial period at 2 weeks
The primary endpoint of this study is the proportion of participants who are able to tolerate patterned DBS (pDBS) for the full two-week intervention period. Tolerability is defined as the ability to remain on the assigned pDBS setting without reverting to an alternative DBS configuration.
2 secondary outcomes
Change in motor symptom severity
Time frame: From enrollment to the end of study period at 4 weeks
Change in quality of life
Time frame: From enrollment to the end of the study period at 4 weeks
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 6 Jul 2026.
- Background: PubMed 32357269Horn MA, Gulberti A, Gulke E, Buhmann C, Gerloff C, Moll CKE, Hamel W, Volkmann J, Potter-Nerger M. A New Stimulation Mode for Deep Brain Stimulation in Parkinson's Disease: Theta Burst Stimulation. Mov Disord. 2020 Aug;35(8):1471-1475. doi: 10.1002/mds.28083. Epub 2020 May 1.
- Background: PubMed 33981207Wong JK, Hu W, Barmore R, Lopes J, Moore K, Legacy J, Tahafchi P, Jackson Z, Judy JW, Raike RS, Wang A, Tsuboi T, Okun MS, Almeida L. Safety and Tolerability of Burst-Cycling Deep Brain Stimulation for Freezing of Gait in Parkinson's Disease. Front Hum Neurosci. 2021 Apr 26;15:651168. doi: 10.3389/fnhum.2021.651168. eCollection 2021.
- Background: PubMed 27000764Akbar U, Raike RS, Hack N, Hess CW, Skinner J, Martinez-Ramirez D, DeJesus S, Okun MS. Randomized, Blinded Pilot Testing of Nonconventional Stimulation Patterns and Shapes in Parkinson's Disease and Essential Tremor: Evidence for Further Evaluating Narrow and Biphasic Pulses. Neuromodulation. 2016 Jun;19(4):343-56. doi: 10.1111/ner.12397. Epub 2016 Mar 22.
- Individual participant dataSharing planned: Yes. De-identified primary and secondary outcome data
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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 Biphasic deep brain stimulation, Conventional deep brain stimulation and Theta burst deep brain stimulation in people with Parkinson Disease and Deep Brain Stimulation, 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 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 6 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 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?
Tolerability of patterned DBS (time frame: From enrollment to the end of novel waveform trial period at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07410598, which also lists 3 linked publications.
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 6 Jul 2026.