directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up

Status Not yet recruiting

Clinical Trial Summary

This is a prospective, multi-center, single arm post-market clinical follow-up study. The present study investigates a product authorized on the European market that will be used per its intended use, and all procedures involved follow the standard of care. This is an observational study to provide clinical evidence in support of DBS effectiveness in the treatment of ET when delivered by the directSTIM DBS system. Twenty-one patients will be enrolled in this study. Subjects selected to participate in the study will be ET patients referred to uni- or bilateral DBS implant who meet the inclusion criteria and none of the exclusion criteria. Primary effectiveness variables will be measured at baseline for the identification of the worst limb (most affected by the disease), then 3 months post-surgery. Safety events will be collected between implant and 3-month visit, to evaluate potential confounding factors. After completing the 3-month visit, subjects will exit the study, and continue to be followed by their physician per usual care. Study will be conducted at minimum 3 centers in Europe.

Clinical Trial Description

This study investigates the benefits and safety of the use of the directSTIM Deep Brain Stimulation (DBS) system within its intended use, to deliver DBS therapy to patients suffering from Essential Tremor (ET) whose motor symptoms are no longer optimally controlled through pharmaceutical treatment. The objective of this study is to show that directSTIM is not inferior to competitor DBS Systems at alleviating postural or kinetic symptoms of Essential Tremor through the delivery of Deep Brain Stimulation therapy. Data to be analyzed will be collected from ET patients referred for DBS surgery, who chose to get the directSTIM DBS System implanted after discussing its risks and benefits with their clinician. All procedures involving the patient and the device follow the standard of care in place at the site for DBS. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05795218
Study type	Observational
Source	Aleva Neurotherapeutics SA
Contact	Alain Dransart
Phone	+4121 353 8764
Email	clinical@aleva-neuro.com
Status	Not yet recruiting
Phase
Start date	October 2023
Completion date	July 2025

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

directSTIM™ Deep Brain Stimulation System Post-Market Clinical Follow-up Study on Essential Tremor

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms