Parkinson Disease, IdiopathicADVENTNCT06891781
Investigating Adaptive Deep Brain Stimulation in Parkinson's Disease Management
A study testing Deep Brain Stimulation in people with Parkinson Disease, Idiopathic, run by Newronika at 1 site in Italy.
Trial summary
The goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Idiopathic
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteItaly
- Study dates
- 26 Aug 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical trial:
- Is willing and capable of signing informed consent
- Is ≥18 years old
- Has been diagnosed with levodopa-responsive idiopathic Parkinson's disease
- Has a Hoehn and Yahr (H\&Y) scale stage of II or III when OFF medication at screening
- Exhibits motor fluctuations and PD-related symptoms that are not adequately controlled with medication, including motor complications of recent onset (>4 months duration)
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- Has been referred for bilateral STN DBS in accordance with local practice
- Must be a good surgical candidate for placement of a deep brain stimulator as judged by the DBS surgical team
- Montreal Cognitive Assessment (MoCA) score of ≥ 26 at the Baseline/Screening visit (when in "MedsON" state)
- UPDRS-III improvement by ≥30% with the levodopa challenge test as measured at approximately 90 minutes following administration of the challenge dose
- ≥4 hours per day (waking hours) with poor motor symptoms control (time "OFF" plus time "ON" with dyskinesia) despite optimal medical therapy, as assessed by the 3-day diary (at preop baseline)
- Subject successfully completed a test diary reaching a sufficient level of agreement (>75%) with study personnel responses and is willing and capable of completing a 3-day diary at each of the time points required per the protocol
- If female, subjects who are not currently pregnant as determined by negative serum pregnancy test, breastfeeding, or who are post-menopausal, surgically sterile or willing to use birth control for the duration of the study (acceptable forms of birth control are: hormone therapies (oral, injected, transdermal or implanted), IUD or other barrier methods (e.g., condom, diaphragm, cervical cap, spermicide/gel) or partner is surgically sterile
- Subject maintained a constant anti-PD medication treatment (best medical management, as duly documented) for at least 2 weeks prior to Baseline assessments
- Subject is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow up visits
Who cannot join
- The subject must not meet any of the following exclusion criteria:
- Has contraindications for DBS surgery, including any intracranial abnormality (e.g., generalized atrophy, vascular malformation, hydrocephalus, hematoma, cavernous or venous angioma, tumor or metastases, midline shift, etc.) or metallic implant (e.g., aneurysm clip, cochlear implant, etc.) or other clinically significant space-occupying lesion which in the opinion of the surgeon would impact the ability to target and place the leads or IPG
- Is not on a stable dose of levodopa anti-Parkinson's disease medication for at least 2 weeks prior to Screening/Baseline assessments
- Has any current major psychiatric disorder(s), such as Major Depressive Disorder, Bipolar I or II disorder, Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Brief Psychotic Disorder, Obsessive-Compulsive Disorder, or any other current psychiatric condition that in the opinion of the investigator would confound the assessment of study endpoints, prevent proper data collection and/or compromise the subject's ability to participate, based on the psychiatric/psychological assessment at screening.
- (It is permitted if a subject has a diagnosis of Major Depressive Disorder with symptoms that currently are well-controlled and managed by a stable regimen of antidepressants for a minimum of 4 weeks prior to the screening visit). Includes current moderate or severe alcohol and/or substance use disorder based on the psychiatric/psychological assessment at screening.
- A history of suicide attempt within 3 years of the screening visit or current active suicidal ideation as determined by a psychiatric/psychological evaluation
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- Any medical condition, such as cognitive impairment, dementia, seizures, congestive heart failure, unstable angina, uncontrolled diabetes, renal failure requiring dialysis, or any other severe medical condition that could interfere with study procedures, confound the assessment of study endpoints, prevent proper data collection, or that, in the opinion of the investigator, would compromise the subject's ability to participate
- Confirmation of diagnosis of a terminal illness associated with survival <12 months
- Needs repeated MRI scans
- Requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
- Has an electrical or electromagnetic implant (e.g., cochlear prosthesis, pacemaker, neurostimulator, etc.) or plans to obtain, an active implanted medical device (AIMD) and/or an implanted medication pump (e.g., DUOPA™ infusion pump) and/or is treated with a portable infusion pump for any indication
- Is on anticoagulant therapy which cannot be paused for >5 days before surgery
- A history of cranial surgery including ablation procedure or any other previous neurosurgical procedure for the treatment of PD symptoms on either side of the brain
- Is currently participating in another clinical study (excluding any sub-study of the present trial). The sponsor will not grant waivers or protocol exceptions to any inclusion or exclusion criteria. Safety of subjects is the utmost concern and will be prioritized at every stage throughout this protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS San Gerardo dei Tintori
Monza
Giorgio Giovanni Carrabba, 0392331, giorgio.carrabba@unimib.it
About this study
Official title: A Prospective, Multi-center, Randomized, Double-blind, Cross Over, Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Stimulation in Levodopa- Responsive Parkinson's Disease Treated With Bilateral Deep Brain Stimulation of the Subthalamic Nucleus
The goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Data from previous studies conducted in Europe indicate that the use of the AlphaDBS system is safe and effective in both aDBS and cDBS modes. However, such studies suggest that aDBS may lead to more ON-time without troublesome dyskinesias in some patients. The study is designed to first demonstrate safety of effectiveness of cDBS, then to directly compare effectiveness of aDBS relative to cDBS. Subjects enrolled in the study will undergo multiple visits to assess the improvement of PD symptoms and will be randomized to Mode 1 for three months, followed by Mode 2. At the end of Mode 2, subjects will select their preferred mode, which will be maintained for 3 additional months. Subjects will complete patient diaries at different time points to evaluate their symptoms throughout the day.
- Conditions
- Parkinson Disease, Idiopathic
- Being tested
- Deep Brain Stimulation
- Keywords
- Deep Brain Stimulation, Parkinson Disease, adaptive Deep Brain Stimulation, aDBS, conventional Deep Brain Stimulation, cDBS
- 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 StimulationDevice
AlphaDBS System
| Study group | Role | What they receive |
|---|---|---|
| aDBS | Experimental | adaptive DBS (closed-loop DBS) Receives: Device: Deep Brain Stimulation |
| cDBS | Active comparator | conventional DBS Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Good On Time (GOT)
Mean improvement in GOT with cDBS, when compared with preop baseline, measured at the end of Mode 1, as assessed by a 3-day Hauser diary.
Measured: After 3 months of follow up in cDBS as compared with preop baseline
Secondary outcomes (4)
GOT difference between aDBS and cDBS
The mean difference in GOT (aDBS - cDBS) at the end of the second crossover period
Measured: 6 months of follow up (end of of the second crossover period)
UPDRS III score difference between aDBS and cDBS
The mean difference in UPDRS III scores (aDBS - cDBS) at the end of the second crossover period
Measured: 6 months of follow up (end of of the second crossover period)
PDQ-39 score difference between aDBS and cDBS
The mean difference in PDQ-39 score (aDBS - cDBS) at the end of the second crossover period
Measured: 6 months of follow up (end of of the second crossover period)
Subject Preference for aDBS vs. cDBS
The proportion of subjects that prefer adaptive (aDBS) mode over conventional (cDBS)mode, according to subject preference selection
Measured: 6 months of follow up (end of of the second crossover period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start26 Aug 2026
- Primary completionAug 2028 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- It is a prospective, multi-center, randomized, double-blind, cross over clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newronika
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06891781
- Sponsor's protocol ID
- NWK_Pivotal_aDBS-PV01
- Acronym
- ADVENT
- Status last verified
- Sep 2026
- First submitted
- 11 Mar 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Double-blind, Cross Over, Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Stimulation in Levodopa- Responsive Parkinson's Disease Treated With Bilateral Deep Brain Stimulation of the Subthalamic Nucleus
- ClinicalTrials.gov ID
- NCT06891781
- Acronym / sponsor ID
- ADVENT / NWK_Pivotal_aDBS-PV01
- Conditions
- Parkinson Disease, Idiopathic
- Keywords
- Deep Brain Stimulation, Parkinson Disease, adaptive Deep Brain Stimulation, aDBS, conventional Deep Brain Stimulation, cDBS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- NewronikaIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 24 Mar 2025 (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 goal of this prospective, multi-center, randomized, double-blind, crossover clinical trial is to evaluate the effectiveness and safety of adaptive DBS (aDBS) and conventional DBS (cDBS) delivered through the AlphaDBS system, in levodopa-responsive Parkinson's disease subjects. Data from previous studies conducted in Europe indicate that the use of the AlphaDBS system is safe and effective in both aDBS and cDBS modes. However, such studies suggest that aDBS may lead to more ON-time without troublesome dyskinesias in some patients. The study is designed to first demonstrate safety of effectiveness of cDBS, then to directly compare effectiveness of aDBS relative to cDBS. Subjects enrolled in the study will undergo multiple visits to assess the improvement of PD symptoms and will be randomized to Mode 1 for three months, followed by Mode 2. At the end of Mode 2, subjects will select their preferred mode, which will be maintained for 3 additional months. Subjects will complete patient diaries at different time points to evaluate their symptoms throughout the day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- It is a prospective, multi-center, randomized, double-blind, cross over clinical trial
| Arm | Type | Receives |
|---|---|---|
| aDBS | Experimental | Device: Deep Brain Stimulationadaptive DBS (closed-loop DBS) |
| cDBS | Active comparator | Device: Deep Brain Stimulationconventional DBS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Subjects who meet all of the following criteria may be given consideration for inclusion in this clinical trial:
- Is willing and capable of signing informed consent
- Is ≥18 years old
- Has been diagnosed with levodopa-responsive idiopathic Parkinson's disease
- Has a Hoehn and Yahr (H\&Y) scale stage of II or III when OFF medication at screening
Key exclusion criteria (14 listed)
- Has contraindications for DBS surgery, including any intracranial abnormality (e.g., generalized atrophy, vascular malformation, hydrocephalus, hematoma, cavernous or venous angioma, tumor or metastases, midline shift, etc.) or metallic implant (e.g., aneurysm clip, cochlear implant, etc.) or other clinically significant space-occupying lesion which in the opinion of the surgeon would impact the ability to target and place the leads or IPG
- Is not on a stable dose of levodopa anti-Parkinson's disease medication for at least 2 weeks prior to Screening/Baseline assessments
- Has any current major psychiatric disorder(s), such as Major Depressive Disorder, Bipolar I or II disorder, Schizophrenia, Schizoaffective Disorder, Delusional Disorder, Brief Psychotic Disorder, Obsessive-Compulsive Disorder, or any other current psychiatric condition that in the opinion of the investigator would confound the assessment of study endpoints, prevent proper data collection and/or compromise the subject's ability to participate, based on the psychiatric/psychological assessment at screening.
- (It is permitted if a subject has a diagnosis of Major Depressive Disorder with symptoms that currently are well-controlled and managed by a stable regimen of antidepressants for a minimum of 4 weeks prior to the screening visit). Includes current moderate or severe alcohol and/or substance use disorder based on the psychiatric/psychological assessment at screening.
- A history of suicide attempt within 3 years of the screening visit or current active suicidal ideation as determined by a psychiatric/psychological evaluation
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 StimulationAlphaDBS System | Device | aDBS, cDBS |
Primary outcome
Improvement in Good On Time (GOT)
Time frame: After 3 months of follow up in cDBS as compared with preop baseline
Mean improvement in GOT with cDBS, when compared with preop baseline, measured at the end of Mode 1, as assessed by a 3-day Hauser diary.
4 secondary outcomes
GOT difference between aDBS and cDBS
Time frame: 6 months of follow up (end of of the second crossover period)
UPDRS III score difference between aDBS and cDBS
Time frame: 6 months of follow up (end of of the second crossover period)
PDQ-39 score difference between aDBS and cDBS
Time frame: 6 months of follow up (end of of the second crossover period)
Subject Preference for aDBS vs. cDBS
Time frame: 6 months of follow up (end of of the second crossover period)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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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.
1 site 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, Idiopathic, run by Newronika at 1 site in Italy.
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 15 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Good On Time (GOT) (time frame: After 3 months of follow up in cDBS as compared with preop baseline). 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 24 Sep 2026.