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Coordinated Reset Deep Brain Stimulation for Parkinson's Disease

Study acronym: CR DBS PD
StatusNot Yet Recruiting
PhasePhase 1
Started
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Record History

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  1. Notable Start date pushed from Oct 10, 2026 to Dec 1, 2026
    • Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 19 of 22 entries
  2. Notable Start date: Sep 1, 2026 to Oct 10, 2026v5
  3. Notable Start date: Jul 1, 2026 to Sep 1, 2026v4
  4. Notable Start date: May 1, 2026 to Jul 1, 2026v3
  5. Notable Start date: Feb 1, 2026 to May 1, 2026v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Deep brain stimulation (DBS) is a surgical implant procedure for the treatment of Parkinson's Disease (PD) utilizing medical devices approved by the FDA. A novel approach to current DBS approaches is called "Coordinated Reset" DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude and high frequency stimulation. This study will evaluate the safety and short-term efficacy of CR-DBS in PD. The results from this study will significantly advance the development of CR-DBS for the treatment of PD. Findings in this study will also provide the rationale for further development of this novel DBS approach for other neurological and psychiatric disorders.
Trial Details
NCT Number NCT07340073
Lead Sponsor University of Minnesota
Conditions
(from sponsor)
Parkinson's Disease (PD), Deep Brain Stimulation
Related terms Parkinson Disease
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov