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Connectomic Guided DBS for Parkinson's Disease

NCT06618157 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Parkinson Disease
  • Tremor
  • Dyskinesias

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Kyle Mitchell, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-16
Primary Completion
2026-12-29
Completion
2027-01-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06618157 on ClinicalTrials.gov