- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05262348
An Open-label Clinical Trial to Compare the Safety and Effectiveness of Adaptive Versus Conventional Deep Brain Stimulation (ADVENT)
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jason Jones
- Phone Number: 901-451-4792
- Email: jason.jones@newronika.com
Study Contact Backup
- Name: Costanza Conti, PhD
- Phone Number: +393405314424
- Email: costanza.conti@newronika.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Phase 1a - conventional stimulation
Stimulation will be delivered bilaterally to the STN or the GPi.
The stimulation parameters will be based upon standard practice by the neurologist.
|
The AlphaDBS IPG System delivers both conventional DBS and adaptive DBS.
Conventional DBS is programmed by DBS specialists.
Other Names:
|
EXPERIMENTAL: Phase 1b - adaptive stimulation
Stimulation 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess Treatment-Emergent Adverse Events
Time Frame: 9 months
|
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.
|
9 months
|
To compare change in Good on time (GOT) when the patient receives aDBS versus change in GOT when the patient receives cDBS.
Time Frame: 9 months
|
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.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate, number of patients with at least 2 hours improvement in each treatment mode
Time Frame: 9 months
|
Treatement success is defined as number of patients with >2 hours ∆GOTaDBS and ∆GOTcDBS
|
9 months
|
Patient fluctuations
Time Frame: 9 months and 36 months
|
Number of ON/OFF transitions based on the 3-day diary
|
9 months and 36 months
|
UPDRS III
Time Frame: 9 months and 36 months
|
UPDRS III score, in MedOFF-StimON and MedON-StimON conditions
|
9 months and 36 months
|
UdysRS
Time Frame: 9 months and 36 months
|
Score of the Unified Dyskinesia Rating Scale (UdysRS) in MedOFF-StimON and MedON-StimON condition.
|
9 months and 36 months
|
Percentage of time in which the system is used in aDBS mode
Time Frame: 28 months
|
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.
|
28 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NWK_AlphaDBS_PIV_2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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