NCT06618157

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
9mo left

Started Feb 2026

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress23%
Feb 2026Jan 2027

First Submitted

Initial submission to the registry

September 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

February 16, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2027

Last Updated

February 20, 2026

Status Verified

September 1, 2025

Enrollment Period

11 months

First QC Date

September 26, 2024

Last Update Submit

February 19, 2026

Conditions

Parkinson DiseaseTremorDyskinesias

Keywords

DBSParkinson's diseaseConnectomicTremorDyskinesiaWearable

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Approximately eight hours

Secondary Outcomes (1)

  • Tremor severity as measured by the Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)

    Approximately eight hours

Study Arms (2)

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.

Device: Cerebellothalamic optimized deep brain stimulationDevice: Pallidothalamic optimized deep brain stimulationOther: No deep brain stimulationDevice: 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.

Device: Cerebellothalamic optimized deep brain stimulationDevice: Pallidothalamic optimized deep brain stimulationOther: No deep brain stimulationDevice: Usual care deep brain stimulation

Interventions

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

No oral dopaminergic medicationOn oral dopaminergic medication
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 oral dopaminergic medicationOn oral dopaminergic medication
No deep brain stimulationOTHER

Patients will also be tested without any deep brain stimulation

No oral dopaminergic medicationOn oral dopaminergic medication
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

No oral dopaminergic medicationOn oral dopaminergic medication

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Health Center at Morreene Road

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseTremorDyskinesias

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kyle Mitchell, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 1, 2024

Study Start

February 16, 2026

Primary Completion (Estimated)

December 29, 2026

Study Completion (Estimated)

January 29, 2027

Last Updated

February 20, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)