Parkinson DiseaseNCT04681534
Safety and Efficacy of Adaptive Deep Brain Stimulation
A study testing AlphaDBS System in people with Parkinson Disease, run by Newronika at 8 sites in 3 countries.
Trial summary
The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the "AlphaDBS" System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- AlphaDBS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 26 Jan 2021to 30 Dec 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD;
- Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel);
- DBS implant for at least 3 years and in need of battery replacement within 12 months after consent;
- Patients must be able to understand and sign the informed consent document.
- Patient is ≥ 18 years old;
- Patient has been diagnosed with levodopa-responsive idiopathic Parkinson's disease for ≥ 5 years;
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- The disease stage is II, III or IV according to the Hoehn and Yahr scale
- Patient has history of improvement of PD-related symptoms as a direct result of levodopa intake;
- 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 or Abbott directional leads model number 6170 or 6172 or 6371, independently from this study, in accordance with local standard of care for DBS;
- Patient has DBS-leads circuit integrity assessed and confirmed by impedance testing, before IPG implantation;
- MoCA score > 26 in best medical condition;
- BDI-II score < 17 in best medical condition;
- UPDRS-III improvement by ≥ 33% with levodopa challenge test (at approximately 90 min from the intake of the usual morning levodopa dose plus 30%);
- Patient is able to understand the study requirements and the treatment procedures and has provided written informed consent to participate;
- 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 on stable PD-medication for one month prior surgery;
- Patient is willing and able to attend all study-required visits, complete the study procedures and attend appropriate follow up visits.
Who cannot join
- Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score < 10);
- Patients with major psychiatric issues or any other condition that, based on the physician opinion, could interfere with the study conduct (e.g. severe depression, psychosis, etc.);
- Patients with any medical conditions potentially interfering with DBS battery replacement surgery (e.g. severe hypertension, active cancer, intake of drugs interfering with the coagulation etc.);
- Need to replace or reposition the leads during the IPG replacement procedure;
- Patients with > 10 recurrent falls experienced in the 3 months prior to consent;
- Patients that cannot tolerate an interruption of DBS stimulation for at least 30 min;
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- Patients taking less than one levodopa dose per day;
- Patients without suitable LFPs recordings or with significant artifacts;
- Pregnant or breastfeeding women.
- De Novo DBS Patients:
- 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 (C-SSRS);
- 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;
- Patients without suitable LFPs recordings or with significant artifacts.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Italy5 sites, 1 recruiting
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Linda Borellini, MD
Enrico Mailland, MD
- Completed
IRCCS Istituto Neurologico Carlo Besta
Milan
- Withdrawn
Azienda Ospedale Universitario di Padova - Università di Padova
Padova
- Completed
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome
- Completed
AOU Città della Salute e della Scienza di Torino
Turin
Poland2 sites
- Withdrawn
Copernicus Podmiot Leczniczy
Gdansk
- Completed
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw
About this study
Official title: A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered Through AlphaDBS System in Patients With Parkinson's Disease
The aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the "AlphaDBS" System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN) for DBS.
Read the detailed description
The study protocol is organized in two phases: the "short-term follow-up" and the "long-term follow-up".
PD patients in need of IPG replacement or "de novo DBS" patients will be screened for enrollment eligibility.
For the "short-term follow-up", randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). This part of the study will collect information on safety and potential efficacy endpoints as assessed by experienced neurologists. The "short term follow-up" phase will be considered complete when the endpoint assessment has been performed for all patients.
Patients, who will not experience severe side effects and who will be deemed suitable by the neurologist, will be eligible to continue in the "long-term follow-up" phase (i.e. 1 month) in their "home" environment. The "AlphaDBS" System will deliver the stimulation in aDBS or cDBS mode, for two weeks in each mode.
- Conditions
- Parkinson Disease
- Being tested
- AlphaDBS System
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlphaDBS SystemDevice
AlphaDBS can be programmed with two different types of stimulation: conventional DBS and adaptive DBS, that automatically adjusts the energy delivered to patient using a biosignal, local field potential (LFP), in a close loop configuration.
| Study group | Role | What they receive |
|---|---|---|
| conventional DBS | Active comparator | Not described Receives: Device: AlphaDBS System |
| adaptive DBS | Experimental | Not described Receives: Device: AlphaDBS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode
Occurrence of device related adverse events
Measured: 1 month
Secondary outcomes (8)
PD-related motor symptoms and their fluctuations
Evaluation of PD-related motor symptoms using the Unified Parkinson's Disease Rating Scale - UPDRS Part III.
Measured: 1 month
Dyskinesia
Evaluation of dyskinesia and their fluctuations through repeated clinical assessments using the Unified Dyskinesia Rating Scale - UDysRS
Measured: 1 month
Dyskinesia
Evaluation of the performance of a wearable accelerometer in detecting dyskinesia (compared to patient reported dyskinesia in the patient diary)
Measured: up to 1 month
"Time on" with and without dyskinesia
Evaluation of "time on" with and without dyskinesia, assessed through Patient Diary
Measured: 1 month
"Time off"
Evaluation of "time off", assessed through Patient Diary
Measured: 1 month
Patient controller usability
Usability will be evaluated by means of a usability questionnaire
Measured: 1 month
Usability of the system for the physician
Usability will be evaluated by means of a usability questionnaire
Measured: 1 month
Change in the TEED to the patient
Change in the Total Electrical Energy Delivered (TEED) to the patient
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start26 Jan 2021
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newronika
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681534
- Sponsor's protocol ID
- NWK_AlphaDBS_FIM_2019
- Status last verified
- Jul 2024
- First submitted
- 20 Nov 2020
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marceglia S, Conti C, Svanidze O, Foffani G, Lozano AM, Moro E, Volkmann J, Arlotti M, Rossi L, Priori A. Double-blind cross-over pilot trial protocol to evaluate the safety and preliminary efficacy of long-term adaptive deep brain stimulation in patients with Parkinson's disease. BMJ Open. 2022 Jan 3;12(1):e049955. doi: 10.1136/bmjopen-2021-049955.
PubMed 34980610
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Crossover Study to Evaluate the Safety and Efficacy of Adaptive Deep Brain Stimulation Delivered Through AlphaDBS System in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04681534
- Acronym / sponsor ID
- NWK_AlphaDBS_FIM_2019
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- NewronikaIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 23 Dec 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 aim of this study is to assess the safety and the potential efficacy of personalized Local Field Potential (LFP)-based adaptive Deep Brain Stimulation (aDBS), using the implantable pulse generator (IPG) of the "AlphaDBS" System, in Parkinson's Disease patients, chronically implanted in subthalamic nucleus (STN) for DBS.
Detailed description
The study protocol is organized in two phases: the "short-term follow-up" and the "long-term follow-up".
PD patients in need of IPG replacement or "de novo DBS" patients will be screened for enrollment eligibility.
For the "short-term follow-up", randomized patients will undergo 2 days of experimental sessions (i.e. one per each type of stimulation mode, cDBS and aDBS), in a well-controlled environment (i.e. during hospitalization). This part of the study will collect information on safety and potential efficacy endpoints as assessed by experienced neurologists. The "short term follow-up" phase will be considered complete when the endpoint assessment has been performed for all patients.
Patients, who will not experience severe side effects and who will be deemed suitable by the neurologist, will be eligible to continue in the "long-term follow-up" phase (i.e. 1 month) in their "home" environment. The "AlphaDBS" System will deliver the stimulation in aDBS or cDBS mode, for two weeks in each mode.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional DBS | Active comparator | Device: AlphaDBS System |
| adaptive DBS | Experimental | Device: AlphaDBS System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Diagnosis of idiopathic PD;
- Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel);
- DBS implant for at least 3 years and in need of battery replacement within 12 months after consent;
- Patients must be able to understand and sign the informed consent document.
- Patient is ≥ 18 years old;
Key exclusion criteria (24 listed)
- Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score < 10);
- Patients with major psychiatric issues or any other condition that, based on the physician opinion, could interfere with the study conduct (e.g. severe depression, psychosis, etc.);
- Patients with any medical conditions potentially interfering with DBS battery replacement surgery (e.g. severe hypertension, active cancer, intake of drugs interfering with the coagulation etc.);
- Need to replace or reposition the leads during the IPG replacement procedure;
- Patients with > 10 recurrent falls experienced in the 3 months prior to consent;
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 |
|---|---|---|
| AlphaDBS SystemAlphaDBS can be programmed with two different types of stimulation: conventional DBS and adaptive DBS, that automatically adjusts the energy delivered to patient using a biosignal, local field potential (LFP), in a close loop configuration. | Device | adaptive DBS, conventional DBS |
Primary outcome
Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode
Time frame: 1 month
Occurrence of device related adverse events
8 secondary outcomes
PD-related motor symptoms and their fluctuations
Time frame: 1 month
Dyskinesia
Time frame: 1 month
Dyskinesia
Time frame: up to 1 month
"Time on" with and without dyskinesia
Time frame: 1 month
"Time off"
Time frame: 1 month
Patient controller usability
Time frame: 1 month
Usability of the system for the physician
Time frame: 1 month
Change in the TEED to the patient
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Derived from this study: PubMed 34980610Marceglia S, Conti C, Svanidze O, Foffani G, Lozano AM, Moro E, Volkmann J, Arlotti M, Rossi L, Priori A. Double-blind cross-over pilot trial protocol to evaluate the safety and preliminary efficacy of long-term adaptive deep brain stimulation in patients with Parkinson's disease. BMJ Open. 2022 Jan 3;12(1):e049955. doi: 10.1136/bmjopen-2021-049955.
- Individual participant dataSharing planned: No
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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.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AlphaDBS System in people with Parkinson Disease, run by Newronika at 8 sites in 3 countries.
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 24 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 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy, Poland, Netherlands. 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 Costanza Conti, PhD (+39 02 84 109 381, costanza.conti@newronika.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode (time frame: 1 month). 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 NCT04681534, which also lists 1 linked publication.
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 Jul 2024.