Connectomic Guided DBS for Parkinson's Disease

February 19, 2026 updated by: Duke University

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Health Center at Morreene Road

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: No oral dopaminergic medication

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.
Device: Cerebellothalamic optimized deep brain stimulation
A deep brain stimulation plan will be created by maximizing the cerebellothalamic pathway on the patient-specific connectomic deep brain stimulation model
Device: Pallidothalamic optimized deep brain stimulation
A deep brain stimulation plan will be created by maximizing the Pallidothalamic pathway on the patient-specific connectomic deep brain stimulation model
Other: No deep brain stimulation
Patients will also be tested without any deep brain stimulation
Device: Usual care deep brain stimulation
Patient will also be tested with the deep brain stimulation clinical settings that were previously established during usual care with their neurologist
Other: On oral dopaminergic medication

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.
Device: Cerebellothalamic optimized deep brain stimulation
A deep brain stimulation plan will be created by maximizing the cerebellothalamic pathway on the patient-specific connectomic deep brain stimulation model
Device: Pallidothalamic optimized deep brain stimulation
A deep brain stimulation plan will be created by maximizing the Pallidothalamic pathway on the patient-specific connectomic deep brain stimulation model
Other: No deep brain stimulation
Patients will also be tested without any deep brain stimulation
Device: Usual care deep brain stimulation
Patient will also be tested with the deep brain stimulation clinical settings that were previously established during usual care with their neurologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Approximately eight hours
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.
Approximately eight hours
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.
Approximately eight hours
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.
Approximately eight hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tremor severity as measured by the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
Time Frame: Approximately eight hours
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.
Approximately eight hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Kyle Mitchell, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2026

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

January 29, 2027

Study Registration Dates

First Submitted

September 26, 2024

First Submitted That Met QC Criteria

September 26, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 19, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00115972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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