Clinical trial NCT04329676: directSTIM Deep Brain Stimulation System Study
Official title: A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
DBS
PD
Lead sponsor: Aleva Neurotherapeutics SA
Sponsor class: INDUSTRY
First posted: 2020-04-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Change in UPDRS III score without medication
timeFrame: 6 months compared to baseline
measure: Materiovigilance
timeFrame: 6 months
Secondary outcomes:
measure: Therapeutic Window (TW)
timeFrame: 3 months
measure: UPDRS
timeFrame: 6 months
Other outcomes:
measure: Change in PDQ-39 score
timeFrame: 6 months
measure: Change in dopaminergic medication
timeFrame: 6 months
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus Dresden
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein (Kiel)
city: Münster
country: Germany
facility: Universitätsklinikum Münster
Study officials:
affiliation: Aleva Neurotherapeutics SA
name: Alain Dransart
role: STUDY_DIRECTOR
References: