One-Year Effect on Levodopa Equivalent Daily Dose of Thalamic VIM Nucleus Stimulation Compared to Subthalamic Nucleus Stimulation in Patients With Parkinson's Disease
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In plain language
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- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Parkinson Disease (PD), Deep Brain Stimulation. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Detailed description
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.
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Chru Nancy — Nancy
Identifiers
NCT: NCT06936254 · 2024PI211