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Connectomic Guided DBS for Parkinson's Disease

NCT ID: NCT06618157

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-15

Study Completion Date

2027-01-29

Brief Summary

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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

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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

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Parkinson Disease Tremor Dyskinesias

Keywords

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DBS Parkinson's disease Connectomic Tremor Dyskinesia Wearable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The order in which all four scenarios are tested will be randomized. The MDS-UPDRS III scale will be scored blindly by a second rater based on the de-identified video recorded exam. Participants will be blinded to which stimulation is being used during the recording of their exam.

Study Groups

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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.

Group Type OTHER

Cerebellothalamic optimized deep brain stimulation

Intervention Type DEVICE

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 stimulation

Intervention Type DEVICE

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 stimulation

Intervention Type OTHER

Patients will also be tested without any deep brain stimulation

Usual care deep brain stimulation

Intervention Type DEVICE

Patient will also be tested with the deep brain stimulation clinical settings that were previously established during usual care with their neurologist

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.

Group Type OTHER

Cerebellothalamic optimized deep brain stimulation

Intervention Type DEVICE

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 stimulation

Intervention Type DEVICE

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 stimulation

Intervention Type OTHER

Patients will also be tested without any deep brain stimulation

Usual care deep brain stimulation

Intervention Type DEVICE

Patient will also be tested with the deep brain stimulation clinical settings that were previously established during usual care with their neurologist

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

No deep brain stimulation

Patients will also be tested without any deep brain stimulation

Intervention Type OTHER

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyle Mitchell, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke Health Center at Morreene Road

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00115972

Identifier Type: -

Identifier Source: org_study_id