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Search / Trial NCT06618157

Connectomic Guided DBS for Parkinson's Disease

Launched by DUKE UNIVERSITY · Sep 26, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Dbs Parkinson's Disease Connectomic Tremor Dyskinesia Wearable

ClinConnect Summary

This clinical trial is investigating a new way to improve tremor control in people with Parkinson's disease through a method called deep brain stimulation (DBS). The researchers want to use advanced imaging techniques to better understand the brain pathways involved in tremors. By focusing on specific areas, they hope to make DBS more effective at reducing tremors while minimizing side effects like dyskinesias, which are involuntary movements that can sometimes worsen with treatment.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with Parkinson's disease. They should already have a DBS device implanted in their brain for at least three months and experience mild tremors. Participants will undergo assessments to ensure they meet the criteria and can expect to be part of a process that aims to optimize their treatment. This trial is currently recruiting participants, and both men and women are welcome to apply.

Gender

ALL

Eligibility criteria

  • 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

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Kyle Mitchell, MD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported