NCT04329676

directSTIM Deep Brain Stimulation System Study

A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Aleva Neurotherapeutics SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

directSTIM DBS Therapy for Movement Disorders is indicated for patients with disabling tremor or symptoms of Parkinson's disease. Subjects selected to participate in the study will be Parkinson's Disease (PD) patients who are eligible for bilateral DBS for STN therapy and meet the inclusion criteria and none of the exclusion criteria. Primary safety and effectiveness endpoints data will be collected through 6 months of follow-up. The values used for comparison are derived from a review of literature spanning from 2001 to 2019. After completing the 6 month follow-up, subject will exit the study, and continue to be followed by their physician per usual care.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-09
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2020-04-01
• Last updated: 2023-11-09

Locations

6 sites across 1 country: Germany