Clinical trial 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
Official title: One-Year Effect on Levodopa Equivalent Daily Dose of Thalamic VIM Nucleus Stimulation Compared to Subthalamic Nucleus Stimulation in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parkinson Disease (PD)
Deep Brain Stimulation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include patients with Parkinson's disease who underwent deep brain stimulation (DBS) surgery targeting either the subthalamic nucleus (STN) or the ventral intermediate nucleus (VIM) of the thalamus at the CHRU of Nancy between 2014 (DxCare arrivals) and 2024. Eligible patients must have a diagnosis of Parkinson's disease

Brief summary: 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.

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

Primary outcomes:
measure: 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.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Chru Nancy
state: Lorraine
Study officials:
References: