directSTIM Deep Brain Stimulation System Study
A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System
1 other identifier
interventional
62
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable parkinson-disease
Started Jun 2021
Longer than P75 for not_applicable parkinson-disease
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedStudy Start
First participant enrolled
June 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedNovember 9, 2023
October 1, 2023
3.5 years
March 13, 2020
November 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in UPDRS III score without medication
Part 3 of the Unified Parkinson's Disease Rating Scale (UPDRS III), is a series of questions evaluated by the clinician in presence of the patient, focusing on motor symptoms of PD. Score is expressed on a scale of 0 to 108. This score is evaluated at baseline and 6 months post-implant without any anti-Parkinson medication taken. A decrease at 6 months compared to baseline indicates an improvement. The average difference of scores between the two time points is calculated for the whole study subject population. This value is to be compared to the results of a meta-analysis performed on data extracted during a literature search.
6 months compared to baseline
Materiovigilance
Summary statistics on the occurrence of the following categories of adverse events (AEs): * Device-related AEs * Procedure-related AEs * Stimulation-related AEs
6 months
Secondary Outcomes (2)
Therapeutic Window (TW)
3 months
UPDRS
6 months
Other Outcomes (2)
Change in PDQ-39 score
6 months
Change in dopaminergic medication
6 months
Study Arms (1)
Deep Brain Stimulation
EXPERIMENTALPatients will undergo bilateral implant of directSTIM system in the STN.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307, Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106, Germany
Universitätsklinikum Hamburg
Hamburg, 20246, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Universitätsklinikum Schleswig-Holstein (Kiel)
Kiel, 24105, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alain Dransart
Aleva Neurotherapeutics SA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2020
First Posted
April 1, 2020
Study Start
June 9, 2021
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
November 9, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share
Principal Investigator The principal investigator will publish and/or present the data generated from the clinical investigation, following the conditions specified in the Clinical Site Agreement. Sponsor Sponsor will use this data for internal monitoring of product safety and performance for regulatory purposes, by performing regular updates of the safety profile and the planned interim analyses.