Status:
UNKNOWN
directSTIM Deep Brain Stimulation System Study
Lead Sponsor:
Aleva Neurotherapeutics SA
Conditions:
Parkinson Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 Dis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04329676
Start Date
June 9 2021
End Date
December 1 2024
Last Update
November 9 2023
Active Locations (6)
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1
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 01307
2
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
3
Universitätsklinikum Hamburg
Hamburg, Germany, 20246
4
Medizinische Hochschule Hannover
Hanover, Germany, 30625