Parkinson DiseaseNCT06618157
Connectomic Guided DBS for Parkinson's Disease
A study testing Cerebellothalamic optimized deep brain stimulation, Pallidothalamic optimized deep brain stimulation and No deep brain stimulation in people with Parkinson Disease and Tremor, run by Duke University at 1 site in United States.
Trial summary
The objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control in Parkinson's disease patients while avoiding undesirable side effects, with the goal of increasing precision and facilitating the choice of optimal DBS parameters… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Tremor, Dyskinesias
- What is being tested?
- Cerebellothalamic optimized deep brain stimulation, Pallidothalamic optimized deep brain stimulation and No deep brain stimulation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2026to 29 Jan 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
- Age 18 or older
- Diagnosed with Parkinson's disease and has previously been implanted with bilateral subthalamic nucleus deep brain stimulation (DBS)
- Received DBS at least three months prior to the time of the study to allow for optimization of usual clinical care
- With at least mild tremor on a pre-operatory MDS-UPDRS clinical scale as defined by at least 2 out of 4 resting tremor grading on MDS-UPDRS on at least one extremity
Who cannot join
- Not having a post-operative head CT with 1mm or smaller axial slices at least 1 week after initial lead implantation.
- Patients who received DBS less than three months prior to the start of the study
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
Duke Health Center at Morreene Road
Durham, North Carolina, 27705
About this study
Official title: Connectomic Guided Deep Brain Stimulation (DBS) for Parkinson's Disease
The objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control in Parkinson's disease patients while avoiding undesirable side effects, with the goal of increasing precision and facilitating the choice of optimal DBS parameters for certain disease phenotypes. The investigators hypothesize that patient centered subthalamic nucleus deep brain stimulation of cerebellothalamic axonal pathways and pallidothalamic tract activation can provide better tremor control while avoiding worsening dyskinesias in patients with Parkinson's disease with significant tremor.
Read the detailed description
Patients with Parkinson's disease (PD) can suffer from significant disability due to tremors, rigidity, bradykinesia, or motor fluctuations, in addition to non-motor symptoms of the disease. Deep brain stimulation (DBS) is the main surgical approach approved by the US Food and Drug Administration (FDA) for the treatment of medication-refractory PD. Despite recent advances, the selection of DBS parameters is based on trial-and-error experimentation by specialists over the course of months. Better understanding of the optimal network targets for symptomatic control would allow for therapy improvement and simplify the DBS programming process, increase efficiency, and possibly increase access to care.
Most studies of structural connectivity in PD have focused on the analysis of the subthalamic nucleus (STN). Previous studies analyzing structural connectivity of STN DBS have shown that specific motor symptoms benefit from the activation of different networks. Several tracts such as the cerebellothalamic tract (CBT), pallidothalamic (PT) and corticospinal tract (CST) course through the STN and might be relevant for DBS targeting. For patients with essential tremor, stimulation of the CBT might provide better tremor control, but studies in PD are lacking.
The investigators will use connectomic models to better understand the mechanistic qualities of axonal pathways in the STN in Parkinson's disease and address the need for phenotype driven stimulation in PD. Estimating targeted axonal pathways by using connectomic models may guide personalized decision-making and targeting of DBS. It has the potential to improve clinical outcomes and reduce the number of visits needed for DBS optimization.
The study involves the extraction of data collected during routine clinical care, and data collected during the intervention study.
Data collected during routine clinical care includes:
- Demographic characteristics: age, gender, ethnicity, race.
- Clinical characteristics: disease duration, Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) prior to DBS implementation, levodopa equivalent daily dose of medications.
- Imaging data: DBS lead location, stimulation model activation pathway, recruitment curves, percent of each pathway activated with clinical DBS settings
- Conditions
- Parkinson Disease, Tremor, Dyskinesias
- Being tested
- Cerebellothalamic optimized deep brain stimulation, Pallidothalamic optimized deep brain stimulation, No deep brain stimulation, Usual care deep brain stimulation
- Keywords
- DBS, Parkinson's disease, Connectomic, Tremor, Dyskinesia, Wearable
- Medical subject headings
- Parkinson Disease, Tremor, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebellothalamic optimized deep brain stimulationDevice
A deep brain stimulation plan will be created by maximizing the cerebellothalamic pathway on the patient-specific connectomic deep brain stimulation model
Pallidothalamic optimized deep brain stimulationDevice
A deep brain stimulation plan will be created by maximizing the Pallidothalamic pathway on the patient-specific connectomic deep brain stimulation model
No deep brain stimulationOther
Patients will also be tested without any deep brain stimulation
Usual care deep brain stimulationDevice
Patient will also be tested with the deep brain stimulation clinical settings that were previously established during usual care with their neurologist
| Study group | Role | What they receive |
|---|---|---|
| No oral dopaminergic medication | Other | While off of oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized.
Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia. Receives: Device: Cerebellothalamic optimized deep brain stimulation; Device: Pallidothalamic optimized deep brain stimulation; Other: No deep brain stimulation; Device: Usual care deep brain stimulation |
| On oral dopaminergic medication | Other | While on oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized.
Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia. Receives: Device: Cerebellothalamic optimized deep brain stimulation; Device: Pallidothalamic optimized deep brain stimulation; Other: No deep brain stimulation; Device: Usual care deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tremor duration as measured by wearables
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate tremor duration. This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Measured: Approximately eight hours
Tremor severity as measured by wearables
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate tremor severity. This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Measured: Approximately eight hours
Dyskinesia duration as measured by wearables
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate dyskinesia severity duration). This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Measured: Approximately eight hours
Dyskinesia severity as measured by wearables
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate dyskinesia severity. This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Measured: Approximately eight hours
Secondary outcomes (1)
Tremor severity as measured by the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) tremor severity score ranges from 0 to 4, with higher scores indicating greater severity of tremors.
Measured: Approximately eight hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start16 Feb 2026
- Primary completion29 Dec 2026 (estimated)
- Study completion29 Jan 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 Duke UniversityThe 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
- Two alternative deep brain stimulation (DBS) stimulation plans will be created by maximizing the stimulation to the cerebellothalamic tract (1) and to the pallidothalamic tract (2) based on the patient-specific connectomic DBS model previously created with recruitment curves. Participants will be asked to attend one single research encounter for DBS programming, MDS-UPDRS scoring and wearable data collection. During their research visit, MDS-UPDRS III (clinical scale) and wearable data will be collected in different scenarios (each setting will be recorded for 20 minutes): * "OFF" oral dopaminergic medication: during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. This will be collected during the morning. * "ON" oral dopaminergic medication: during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyle Mitchell, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06618157
- Sponsor's protocol ID
- Pro00115972
- Status last verified
- Sep 2026
- First submitted
- 26 Sep 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connectomic Guided Deep Brain Stimulation (DBS) for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06618157
- Acronym / sponsor ID
- Pro00115972
- Conditions
- Parkinson Disease, Tremor, Dyskinesias
- Keywords
- DBS, Parkinson's disease, Connectomic, Tremor, Dyskinesia, Wearable
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 1 Oct 2024 (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 objective of this research is to use advanced connectomic imaging models to identify disease-relevant axonal pathway targets for better tremor control in Parkinson's disease patients while avoiding undesirable side effects, with the goal of increasing precision and facilitating the choice of optimal DBS parameters for certain disease phenotypes. The investigators hypothesize that patient centered subthalamic nucleus deep brain stimulation of cerebellothalamic axonal pathways and pallidothalamic tract activation can provide better tremor control while avoiding worsening dyskinesias in patients with Parkinson's disease with significant tremor.
Detailed description
Patients with Parkinson's disease (PD) can suffer from significant disability due to tremors, rigidity, bradykinesia, or motor fluctuations, in addition to non-motor symptoms of the disease. Deep brain stimulation (DBS) is the main surgical approach approved by the US Food and Drug Administration (FDA) for the treatment of medication-refractory PD. Despite recent advances, the selection of DBS parameters is based on trial-and-error experimentation by specialists over the course of months. Better understanding of the optimal network targets for symptomatic control would allow for therapy improvement and simplify the DBS programming process, increase efficiency, and possibly increase access to care.
Most studies of structural connectivity in PD have focused on the analysis of the subthalamic nucleus (STN). Previous studies analyzing structural connectivity of STN DBS have shown that specific motor symptoms benefit from the activation of different networks. Several tracts such as the cerebellothalamic tract (CBT), pallidothalamic (PT) and corticospinal tract (CST) course through the STN and might be relevant for DBS targeting. For patients with essential tremor, stimulation of the CBT might provide better tremor control, but studies in PD are lacking.
The investigators will use connectomic models to better understand the mechanistic qualities of axonal pathways in the STN in Parkinson's disease and address the need for phenotype driven stimulation in PD. Estimating targeted axonal pathways by using connectomic models may guide personalized decision-making and targeting of DBS. It has the potential to improve clinical outcomes and reduce the number of visits needed for DBS optimization.
The study involves the extraction of data collected during routine clinical care, and data collected during the intervention study.
Data collected during routine clinical care includes:
- Demographic characteristics: age, gender, ethnicity, race.
- Clinical characteristics: disease duration, Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) prior to DBS implementation, levodopa equivalent daily dose of medications.
- Imaging data: DBS lead location, stimulation model activation pathway, recruitment curves, percent of each pathway activated with clinical DBS settings
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two alternative deep brain stimulation (DBS) stimulation plans will be created by maximizing the stimulation to the cerebellothalamic tract (1) and to the pallidothalamic tract (2) based on the patient-specific connectomic DBS model previously created with recruitment curves. Participants will be asked to attend one single research encounter for DBS programming, MDS-UPDRS scoring and wearable data collection. During their research visit, MDS-UPDRS III (clinical scale) and wearable data will be collected in different scenarios (each setting will be recorded for 20 minutes): * "OFF" oral dopaminergic medication: during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. This will be collected during the morning. * "ON" oral dopaminergic medication: during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized
| Arm | Type | Receives |
|---|---|---|
| No oral dopaminergic medication | Other | Device: Cerebellothalamic optimized deep brain stimulation, Device: Pallidothalamic optimized deep brain stimulation, Other: No deep brain stimulation, Device: Usual care deep brain stimulationWhile off of oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia. |
| On oral dopaminergic medication | Other | Device: Cerebellothalamic optimized deep brain stimulation, Device: Pallidothalamic optimized deep brain stimulation, Other: No deep brain stimulation, Device: Usual care deep brain stimulationWhile on oral dopaminergic medication, MDS-UPDRS III (clinical scale) will be collected in different scenarios (each setting will be recorded for 20 minutes): during no DBS stimulation, usual care stimulation, cerebellothalamic optimized, and pallidothalamic optimized. Each participant will also wear a smartwatch (Apple watch) on each upper arm throughout the research encounter to collect total minutes with tremor, total minutes with dyskinesia, and severity of tremors and dyskinesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Diagnosed with Parkinson's disease and has previously been implanted with bilateral subthalamic nucleus deep brain stimulation (DBS)
- Received DBS at least three months prior to the time of the study to allow for optimization of usual clinical care
- With at least mild tremor on a pre-operatory MDS-UPDRS clinical scale as defined by at least 2 out of 4 resting tremor grading on MDS-UPDRS on at least one extremity
Key exclusion criteria (2 listed)
- Not having a post-operative head CT with 1mm or smaller axial slices at least 1 week after initial lead implantation.
- Patients who received DBS less than three months prior to the start of the study
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 |
|---|---|---|
| Cerebellothalamic optimized deep brain stimulationA deep brain stimulation plan will be created by maximizing the cerebellothalamic pathway on the patient-specific connectomic deep brain stimulation model | Device | No oral dopaminergic medication, On oral dopaminergic medication |
| Pallidothalamic optimized deep brain stimulationA deep brain stimulation plan will be created by maximizing the Pallidothalamic pathway on the patient-specific connectomic deep brain stimulation model | Device | No oral dopaminergic medication, On oral dopaminergic medication |
| No deep brain stimulationPatients will also be tested without any deep brain stimulation | Other | No oral dopaminergic medication, On oral dopaminergic medication |
| Usual care deep brain stimulationPatient will also be tested with the deep brain stimulation clinical settings that were previously established during usual care with their neurologist | Device | No oral dopaminergic medication, On oral dopaminergic medication |
Primary outcome
Tremor duration as measured by wearables
Time frame: Approximately eight hours
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate tremor duration. This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Tremor severity as measured by wearables
Time frame: Approximately eight hours
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate tremor severity. This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Dyskinesia duration as measured by wearables
Time frame: Approximately eight hours
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate dyskinesia severity duration). This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
Dyskinesia severity as measured by wearables
Time frame: Approximately eight hours
An Apple iPhone will be used to collect about two hours of data of each participant using accelerometer to estimate dyskinesia severity. This technology has been integrated into the StrivePD application (Rune Labs, San Francisco, CA) and has been used in other studies at Duke University.
1 secondary outcome
Tremor severity as measured by the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
Time frame: Approximately eight hours
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 3 Sep 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.
Kyle Mitchell, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cerebellothalamic optimized deep brain stimulation, Pallidothalamic optimized deep brain stimulation and No deep brain stimulation in people with Parkinson Disease and Tremor, run by Duke University 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 4 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tremor duration as measured by wearables (time frame: Approximately eight hours). The study lists 4 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 3 Sep 2026.