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NCT Number: NCT06936254

One-Year Effect on Levodopa Equivalent Daily Dose of Thalamic VIM Nucleus Stimulation Compared to Subthalamic Nucleus Stimulation in Patients With Parkinson's Disease

This study compares the effects of deep brain stimulation (DBS) of the thalamic VIM nucleus versus the subthalamic nucleus (STN) on the levodopa equivalent daily dose (LEDD) in patients with Parkinson's disease. The goal is to determine whether VIM stimulation, typically used for tremor, can also reduce medication needs. It hypothesizes that STN stimulation leads to greater LEDD reduction, but VIM may offer moderate benefits in selected case

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Key information

About this study

Thesis Summary:

Deep brain stimulation (DBS) is a well-established therapeutic option for patients with advanced Parkinson's disease. The two most commonly targeted structures are the subthalamic nucleus (STN) and the ventral intermediate nucleus (VIM) of the thalamus. While STN stimulation is known to allow a significant reduction in the levodopa equivalent daily dose (LEDD), the effects of VIM stimulation on medication dosage remain less clear, particularly in patients selected for predominant tremor.

Objectives:

To compare the evolution of LEDD one year after DBS targeting the VIM versus the STN in patients with Parkinson's disease.

To assess whether VIM stimulation also enables a meaningful reduction in dopaminergic medication.

To contribute to refining surgical indications based on the patient's clinical profile.

Hypotheses:

STN stimulation leads to a greater reduction in LEDD compared to VIM stimulation.

VIM stimulation, though primarily used for tremor control, may result in moderate LEDD reduction in specific patient profiles.

Surgical target selection should be personalized, considering not only motor symptom control but also the impact on medication requirements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Parkinson's disease
  • Underwent surgery for subthalamic nucleus (STN) or ventral intermediate nucleus (VIM) deep brain stimulation
  • Surgery performed at CHRU of Nancy
  • Surgery performed between 2014 (DxCare implementation) and 2024

Exclusion criteria

  • No clinical diagnosis of Parkinson's disease
  • No initial dopaminergic treatment
  • Surgery not performed at CHRU of Nancy
  • Death within 1 year following surgery

Treatment and study plan

Primary outcomes

  1. Change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN.

    Time frame: The primary endpoint, which is the change in levodopa equivalent daily dose (LEDD), will be measured one year post-surgery in both the VIM and STN DBS groups.

    To compare the one-year change in the levodopa equivalent daily dose (LEDD) between Parkinson's disease patients undergoing deep brain stimulation (DBS) targeting the VIM thalamic nucleus versus the STN.

Study contacts

Contact information is provided by the study sponsor or research team.

Amory Jardel

CONTACT

[email protected]

+33 6 88 45 13 20

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: VIM vs NST

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2025
Registry last updated
Apr 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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