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

NCT05795218 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2024-08-09

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Deep Brain Stimulation

implant and DBS therapy with the directSTIM™ DBS system

Sponsors & Collaborators

  • Aleva Neurotherapeutics SA

    lead INDUSTRY

Principal Investigators

  • Alexandre Michalis · Aleva Neurotherapeutics SA

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-21
Primary Completion
2024-08-08
Completion
2024-08-08

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT05795218 on ClinicalTrials.gov