ENROLLING_BY_INVITATION

Connectomic Guided DBS for Parkinson's Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Connectomic Guided Deep Brain Stimulation (DBS) for Parkinson's Disease

Quick Facts

Study Start:2025-04-15
Study Completion:2027-01-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ENROLLING_BY_INVITATION

Study ID

NCT06618157

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older
  2. * Diagnosed with Parkinson's disease and has previously been implanted with bilateral subthalamic nucleus deep brain stimulation (DBS)
  3. * Received DBS at least three months prior to the time of the study to allow for optimization of usual clinical care
  4. * 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
  1. * Not having a post-operative head CT with 1mm or smaller axial slices at least 1 week after initial lead implantation.
  2. * Patients who received DBS less than three months prior to the start of the study

Contacts and Locations

Principal Investigator

Kyle Mitchell, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Duke University

  • Kyle Mitchell, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-04-15
Study Completion Date2027-01-29

Study Record Updates

Study Start Date2025-04-15
Study Completion Date2027-01-29

Terms related to this study

Keywords Provided by Researchers

  • DBS
  • Parkinson's disease
  • Connectomic
  • Tremor
  • Dyskinesia
  • Wearable

Additional Relevant MeSH Terms

  • Parkinson Disease
  • Tremor
  • Dyskinesias