Deep Brain Stimulation for Parkinson's Disease

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

This study is testing a new brain stimulation device to see if it can help people with Parkinson's Disease who still have severe movement problems even after taking their medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aleva Neurotherapeutics SA (Industry-sponsored)
• Locations: 6 sites (Dresden and 5 other locations)
• Trial ID: NCT04329676 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the directSTIM Deep Brain Stimulation (DBS) system in patients with Parkinson's Disease who have disabling motor symptoms despite optimal medical treatment. Participants will undergo bilateral implantation in the subthalamic nucleus and will be monitored for clinical outcomes over a six-month period. Data collected during this time will be analyzed to assess the system's performance compared to existing literature. The study aims to provide valuable insights into the use of DBS therapy for managing Parkinson's Disease symptoms.

Who should consider this trial

Good fit: Ideal candidates are individuals with a confirmed diagnosis of idiopathic Parkinson's Disease for at least four years, experiencing disabling motor complications despite optimal medical treatment.

Not a fit: Patients who are not eligible for DBS therapy or those with significant cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the management of Parkinson's Disease symptoms and enhance the quality of life for patients.

How similar studies have performed: Previous studies on Deep Brain Stimulation for Parkinson's Disease have shown promising results, indicating that this approach is well-supported by existing research.

Eligibility criteria

Inclusion Criteria:

* Established diagnosis of idiopathic Parkinson's Disease for 4 years or more according to the United Kingdom Parkinson's disease Brain Bank criteria, with disabling motor complications despite optimal medical treatment.
* Patient is eligible for bilateral DBS for STN therapy according to center's routine criteria and according to the directSTIM DBS system Indications for Use statement.
* Patient who is willing to provide a written informed consent.
* Patient complies with the study follow-up, in particular the follow-up visits, and other study requirements.

Exclusion Criteria:

* Patient is not eligible for DBS per center criteria.
* Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to complete study assessments, such as:

  * Active major psychiatric disorder.
  * Dementia (MoCa Dementia Rating Scale score \<26 or otherwise not capable of discernment).
  * Presence of an electrical or electromagnetic implant (e.g. cochlear implant, pacemaker).
  * Previous surgery for the treatment of Parkinson's disease.
  * Previous brain ablation procedure.
  * Epilepsy.
  * Coagulopathies.
  * Abuse of drugs or alcohol.
* Patient is participating in another clinical study that would confound data analysis.
* Patient is pregnant or nursing. As for other DBS systems, the effects of the device on an unborn child are not established.

Where this trial is running

Dresden and 5 other locations

• Universitätsklinikum Carl Gustav Carus Dresden — Dresden, Germany (Recruiting)
• Universitätsklinikum Freiburg — Freiburg, Germany (Recruiting)
• Universitätsklinikum Hamburg — Hamburg, Germany (Recruiting)
• Medizinische Hochschule Hannover — Hannover, Germany (Recruiting)
• Universitätsklinikum Schleswig-Holstein (Kiel) — Kiel, Germany (Recruiting)
• Universitätsklinikum Münster — Münster, Germany (Recruiting)

Study contacts

• Study coordinator: Alain Dransart

Conditions Parkinson Disease; Deep Brain Stimulation; DBS; PD