ClinicalTrials.Veeva

Menu

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

C

Central Hospital, Nancy, France

Status

Not yet enrolling

Conditions

Deep Brain Stimulation
Parkinson Disease (PD)

Study type

Observational

Funder types

Other

Identifiers

NCT06936254
2024PI211

Details and patient eligibility

About

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

Full 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.

Enrollment

94 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

94 participants in 2 patient groups

VIM group
Description:
Patients in this group underwent deep brain stimulation (DBS) targeting the ventral intermediate nucleus (VIM) of the thalamus. VIM stimulation is primarily used for the control of tremor in Parkinson's disease patients, particularly those with tremor-dominant symptoms. This group includes individuals who were selected for DBS due to the prominence of tremor in their clinical presentation, with less emphasis on other motor symptoms such as bradykinesia or rigidity
NST group
Description:
Patients in this group underwent DBS targeting the subthalamic nucleus (STN). STN stimulation is commonly used in patients with advanced Parkinson's disease, particularly for those who experience motor fluctuations, dyskinesias, and who require a significant reduction in dopaminergic medication. This group includes patients who were selected for DBS based on their overall motor symptoms, including bradykinesia and rigidity, with or without tremor predominance

Trial contacts and locations

1

Loading...

Central trial contact

Amory Jardel

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems