Parkinson DiseaseNCT04329676
directSTIM Deep Brain Stimulation System Study
A study testing Deep Brain Stimulation in people with Parkinson Disease, run by Aleva Neurotherapeutics SA at 6 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 6 sitesGermany
- Study dates
- 9 Jun 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Recruiting
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Aleva Clinical & Regulatory, +41213538764, clinical@aleva-neuro.com
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Aleva Clinical & Regulatory, +41213538764, clinical@aleva-neuro.com
- Recruiting
Universitätsklinikum Hamburg
Hamburg, 20246
Aleva Clinical & Regulatory, +41213538764, clinical@aleva-neuro.com
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Aleva Clinical & Regulatory, +41213538764, clinical@aleva-neuro.com
- Recruiting
Universitätsklinikum Schleswig-Holstein (Kiel)
Kiel, 24105
Aleva Clinical & Regulatory, +41213538764, clinical@aleva-neuro.com
- Recruiting
Universitätsklinikum Münster
Münster, 48149
Aleva Clinical & Regulatory, +41213538764, clinical@aleva-neuro.com
About this study
Official title: A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, DBS, PD
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Patients will undergo bilateral implant of directSTIM system in the STN. Receives: Procedure: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months
Secondary outcomes (2)
Therapeutic Window (TW)
The therapeutic window is the difference of electrical current values between the stimulation settings that provide maximum alleviation of motor symptoms and the settings for which the first stimulation-induced side effect appears (e.g., eye deviation, muscle contraction, speech impairment).
The wider this window, the more flexibility is offered to the patient for stimulation without causing side-effects.
Measured: 3 months
UPDRS
Other parts (I, II and IV) of the Unified Parkinson's Disease Scale are evaluated at baseline and 6 months post-implant.
Part I is a series of 4 questions assessing Mentation, Behavior and Mood. Patient's score is expressed on a scale of 0 to 16.
Part II is a series of 13 questions assessing Quality of Life in daily activities. Patient's score is expressed on a scale of 0 to 52.
Part IV is a series of 10 questions assessing Complications of Therapy. Patient's score is expressed on a scale of 0 to 23.
A decrease at 6 months compared to baseline indicates an improvement.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start9 Jun 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aleva Neurotherapeutics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alain Dransart, Study director, Aleva Neurotherapeutics SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04329676
- Sponsor's protocol ID
- CLI-12011
- Status last verified
- Oct 2023
- First submitted
- 13 Mar 2020
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Post-market Clinical Follow-up Study of the directSTIM Deep Brain Stimulation (DBS) System
- ClinicalTrials.gov ID
- NCT04329676
- Acronym / sponsor ID
- CLI-12011
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation, DBS, PD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Aleva Neurotherapeutics SAIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Procedure: Deep Brain StimulationPatients will undergo bilateral implant of directSTIM system in the STN. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationPatients 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. | Procedure or surgery | Deep Brain Stimulation |
Primary outcome
Change in UPDRS III score without medication
Time frame: 6 months compared to baseline
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.
Materiovigilance
Time frame: 6 months
Summary statistics on the occurrence of the following categories of adverse events (AEs): * Device-related AEs * Procedure-related AEs * Stimulation-related AEs
2 secondary outcomes
Therapeutic Window (TW)
Time frame: 3 months
UPDRS
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Dransart study director
Aleva Neurotherapeutics SA
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation in people with Parkinson Disease, run by Aleva Neurotherapeutics SA at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alain Dransart (+4121 353 8764, clinical@aleva-neuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in UPDRS III score without medication (time frame: 6 months compared to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.