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directSTIM Deep Brain Stimulation System Study

NCT04329676 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-11-09

No results posted yet for this study

Summary

The purpose of this study is to obtain clinical outcome data on safety and effectiveness of the directSTIM DBS system when used on-label, according to the instructions for use.

All participants will undergo bilateral implant in the subthalamic nucleus (STN) and data collected in common practice will be recorded during six months post-implant and analyzed.

Conditions

  • Parkinson Disease

Interventions

PROCEDURE

Deep Brain Stimulation

Patients with PD who are eligible to bilateral STN DBS surgery and chose to get directSTIM System implanted will be followed over a 6-month period to evaluate changes in their condition.

Sponsors & Collaborators

  • Aleva Neurotherapeutics SA

    lead INDUSTRY

Principal Investigators

  • Alain Dransart · Aleva Neurotherapeutics SA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-09
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329676 on ClinicalTrials.gov