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Parkinson DiseaseADVENTNCT05262348

An Open-label Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Deep Brain Stimulation

A study testing adaptive DBS delivered through AlphaDBS IPG System and conventional DBS delivered through AlphaDBS IPG System in people with Parkinson Disease, run by Newronika.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The clinical trial aims to evaluate the safety and effectiveness of bilateral subthalamic nucleus (STN) and Globus Pallidus internus (GPi) deep brain stimulation (DBS) with the AlphaDBS IPG System when programmed in adaptive versus conventional stimulating modes. Read more about this study

Who is it for?
Ages 55 to 95 years
Conditions the study is for
Parkinson Disease
What is being tested?
adaptive DBS delivered through AlphaDBS IPG System and conventional DBS delivered through AlphaDBS IPG System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2022to 31 Dec 2026
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 55 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient is ≥55 years old
  • Patient has been diagnosed with levodopa-responsive idiopathic Parkinson's disease for ≥5 years
  • The disease stage is II, III or IV according to the Hoehn and Yahr scale
  • Patient has history of improvement of Parkinson's symptoms as a direct result of administering levodopa
  • PD-related symptoms are not adequately controlled with medication, including motor complications of recent onset (>4 months duration)
  • Patient experiences persistent disabling PD-related symptoms or drug side effects (e.g., dyskinesia, motor fluctuations, or disabling "off periods") despite optimal medical therapy
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  • Patient has been selected for bilateral STN or Gpi DBS, independently from this study, in accordance with local standard of care DBS screening
  • Patient has been selected to receive Medtronic leads model 3389 or 37086, independently from this study, in accordance with local standard of care DBS screening
  • Patient has DBS circuit integrity assessed and confirmed by impedance testing, before IPG implantation
  • ≥6 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
  • Montreal Cognitive Assessment (MoCA) >26 in MedON condition
  • Beck Depression Inventory II (BDI-II) score <17 in MedON condition
  • UPDRS-III improvement by ≥33% following intake of anti-parkinsonian medications
  • Patient is able to understand the study requirements and the treatment procedures and has provided written informed consent to participate
  • Patient is willing and capable of completing a 3-day diary and reaches a sufficient level of agreement (> 75%) with study personnel responses
  • Patient has a responsible caregiver who will help completing the 3-day diary, provide feedback on activities of daily living (ADL), and ensure the patient complies with visit schedule
  • Patient is willing to maintain a constant anti-PD medication treatment (best medical management) for at least one month prior to study enrollment
  • Patient is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow up visits

Who cannot join

  • Patient 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.)
  • Patient has a history of suicide attempt or current active suicidal ideation as determined by a positive response to Item 2-5 of suicide ideation sub-scale of the Columbia Suicide Severity Rating Scale (CSSR-S)
  • Patient has dementia, major depression, seizures, congestive heart failure, uncontrolled diabetes, dialysis, substance use disorders as described in DSM-V, or any other severe medical condition
  • Patient has any medical condition that could interfere with study procedures, confound the assessment of study endpoints, or prevent a proper data collection
  • Patient had confirmation of diagnosis of a terminal illness associated with survival <12 months
  • Patient needs repeated MRI scans
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  • Patient requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
  • Patient carries an electrical or electromagnetic implant (e.g., cochlear prosthesis, pacemaker, neurostimulator, etc.)
  • Patient has, or plans to obtain, an implanted electrical stimulation medical device and/or an implanted medication pump (e.g., DUOPATM infusion pump) and/or is treated with a portable infusion pump
  • Patient is on anticoagulant therapy which cannot be paused for >5 days before IPG implant surgery
  • Patient with 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
  • Patient is currently participating in another clinical study (excluding any sub-study of the present study)
  • Patient is a female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.

About this study

Official title: A Prospective, Multi-center, Open-label, Pivotal Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Stimulation in Advanced Levodopa-Responsive Parkinson's Disease Treated With Bilateral Deep Brain Stimulation

The clinical trial aims to evaluate the safety and effectiveness of bilateral subthalamic nucleus (STN) and Globus Pallidus internus (GPi) deep brain stimulation (DBS) with the AlphaDBS IPG System when programmed in adaptive versus conventional stimulating modes. It includes an initial open-label, crossover phase and a long term follow-up phase, during which the patient is free to switch between stimulating modes.

Read the detailed description

This is an international multi-center (North America and Europe) clinical trial to evaluate the safety and effectiveness of bilateral STN and GPi DBS with the AlphaDBS IPG System when programmed in adaptive (aDBS) versus conventional (cDBS) stimulating modes, in patients with advanced levodopa-responsive Parkinson's disease (PD).

The protocol is comprised of:

Phase 1: Initial Treatment Period: Cross-Over Design

  • Phase 1a: All patients will start the study in cDBS mode. After a 1-month post-surgical stabilization, the AlphaDBS IPG System will be turned ON in cDBS mode. Participants will complete a 1-month period of programming optimization (to fine tune medical therapies and stimulation parameters) followed by a 3-month period of cDBS.
  • Phase 1b: At the end of the 3-month follow up in cDBS, participants will be switched to the aDBS mode. Participants will then complete a 1-month period of optimization (to fine tune medical therapies and stimulation parameters) followed by a 3-month period of aDBS.

Phase 2: Long-term follow-up: Naturalistic Follow-up Design Patients completing Phase 1 are eligible to enter long-term follow-up for up to an additional 28 months. During this time, patients are free to change the DBS mode as preferred (with a maximum switches set by the physician). Visits at 6-month follow-ups will collect safety and efficacy data.

Being tested
adaptive DBS delivered through AlphaDBS IPG System, conventional DBS delivered through AlphaDBS IPG System
Keywords
Deep Brain Stimulation
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adaptive DBS delivered through AlphaDBS IPG SystemDevice

    Also called aDBS

    The AlphaDBS IPG System delivers both conventional DBS and adaptive DBS. Adaptive DBS is a programming mode that provides stimulation in a closed-loop adaptive "real-time" fashion, using a biosignal recorded from the same macro-electrodes routinely implanted for DBS as an input variable.

  • conventional DBS delivered through AlphaDBS IPG SystemDevice

    Also called cDBS

    The AlphaDBS IPG System delivers both conventional DBS and adaptive DBS. Conventional DBS is programmed by DBS specialists.

Study groups in NCT05262348
Study groupRoleWhat they receive
Phase 1a - conventional stimulationActive comparatorStimulation will be delivered bilaterally to the STN or the GPi. The stimulation parameters will be based upon standard practice by the neurologist.
Receives: Device: conventional DBS delivered through AlphaDBS IPG System
Phase 1b - adaptive stimulationExperimentalStimulation will be delivered bilaterally to the STN or the GPi, with the neurologist-set therapeutic window (which corresponds to the upper and lower limits for aDBS amplitude). The stimulation will be automatically adapted according to the personalized algorithm based on real time LFP analysis.
Receives: Device: adaptive DBS delivered through AlphaDBS IPG System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess Treatment-Emergent Adverse Events

    To identify Treatment-Emergent Adverse Events (TEAEs) (including serious, device-related, stimulation-related, and/or procedure related TEAEs), discontinuations of aDBS and study discontinuation and physical or neurological findings as categorized by the Data and Safety Monitoring Board.

    Measured: 9 months

  2. To compare change in Good on time (GOT) when the patient receives aDBS versus change in GOT when the patient receives cDBS.

    The expected treatment effectiveness of AlphaDBS IPG System with aDBS mode (∆GOTaDBS = GOTaDBS@3-Months - GOT@Baseline) and with cDBS mode (∆GOTcDBS = GOTcDBS@3-Months - GOT@Baseline) will not differ more than two hours.

    Measured: 9 months

Secondary outcomes (5)

  1. Success rate, number of patients with at least 2 hours improvement in each treatment mode

    Treatement success is defined as number of patients with >2 hours ∆GOTaDBS and ∆GOTcDBS

    Measured: 9 months

  2. Patient fluctuations

    Number of ON/OFF transitions based on the 3-day diary

    Measured: 9 months and 36 months

  3. UPDRS III

    UPDRS III score, in MedOFF-StimON and MedON-StimON conditions

    Measured: 9 months and 36 months

  4. UdysRS

    Score of the Unified Dyskinesia Rating Scale (UdysRS) in MedOFF-StimON and MedON-StimON condition.

    Measured: 9 months and 36 months

  5. Percentage of time in which the system is used in aDBS mode

    During the long term follow up, when the patient will be able to switch between programming modes, the patient preference will be assessed considering the percentage of time in which the system is used in aDBS.

    Measured: 28 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study startAug 2022 (estimated)
  3. Primary completion30 Aug 2024 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Why it stopped: The study design has been revised and this protocol was never activated.

Resources

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
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262348
Sponsor's protocol ID
NWK_AlphaDBS_PIV_2022
Acronym
ADVENT
Status last verified
Aug 2024
First submitted
21 Feb 2022
Last updated
12 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing adaptive DBS delivered through AlphaDBS IPG System and conventional DBS delivered through AlphaDBS IPG System in people with Parkinson Disease, run by Newronika.

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 18 inclusion and 13 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: withdrawn, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess Treatment-Emergent Adverse Events (time frame: 9 months). 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?

On the ClinicalTrials.gov record for NCT05262348.

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 12 Aug 2024.

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