Parkinson DiseaseNCT03422757
Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease
A study testing adaptive Deep Brain Stimulation and conventional Deep Brain Stimulation in people with Parkinson Disease, run by Newronika at 4 sites in Italy.
Trial summary
This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD. The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- adaptive Deep Brain Stimulation and conventional Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 4 sitesItaly
- Study dates
- 1 Jun 2017to 30 Dec 2018
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of idiopathic PD;
- DBS implant since at least 3 years and in need of battery replacement, defined by battery level <25%;
- Patients must be able to sign the informed consent document to participate in the clinical trial;
- Patients with a suboptimal response to DBS treatment.
Who cannot join
- Patients with severe cognitive decline (MMSE <25);
- Patients with major psychiatric issues;
- Patients with any medical condition potentially interfering with DBS battery replacement surgery;
- Patients that cannot tolerate an interruption of DBS stimulation;
- Patients taking only one levodopa dose per day;
- Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure;
- Pregnant or breastfeeding women.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO
Milan
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan
IRCCS Istituto Ortopedico Galeazzi
Milan
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Pavia
About this study
Official title: A Double Blind, Crossover Study to Evaluate Safety and Efficacy of an Adaptive Deep Brain Stimulation Closed-loop Method Compared With Conventional Deep Brain Stimulation in Patients With Parkinson's Disease
This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD.
The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.
Read the detailed description
PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment.
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). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.
- Conditions
- Parkinson Disease
- Being tested
- adaptive Deep Brain Stimulation, conventional 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 Deep Brain StimulationDevice
The investigational medical device ("AlphaDBSvext") is a portable, external, dual mode stimulator that can deliver adaptive DBS or conventional DBS for the treatment of PD.
In the adaptive mode, the device records Local Field Potential activity from the implanted DBS electrode and simultaneously delivers stimulation through the same electrode based on the recorded signal.
conventional Deep Brain StimulationDevice
The same investigational medical device ("AlphaDBSvext") is used to deliver conventional DBS for the treatment of PD. In the conventional mode it delivers constant stimulation.
| Study group | Role | What they receive |
|---|---|---|
| adaptive DBS | Experimental | adaptive Deep Brain Stimulation, by AlphaDBSvext. Receives: Device: adaptive Deep Brain Stimulation |
| conventional DBS | Active comparator | conventional Deep Brain Stimulation, by AlphaDBSvext. Receives: Device: conventional Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Electrical Energy Delivered (TEED) to the patient
Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.
Measured: One day.
Secondary outcomes (3)
Incidence of device related Adverse Events (safety and tolerability)
Number of device relate Adverse Events or abnormal vital signs.
Measured: One day.
Unified Parkinson's Disease Rating Scale (UPDRS) part III
Evaluation of motor symptoms through (UPDRS) part III, motor examination. The total score is computed from scores obtained on 18 items (0 best condition-4 worst condition), some considering multiple body parts.
Measured: One day.
Unified Dyskinesia Rating Scale (UDysRS)
Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).
Measured: One day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start1 Jun 2017
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Why it stopped: Company strategic decision
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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Newronika
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03422757
- Sponsor's protocol ID
- NWK_aDBSext_01_2017
- Status last verified
- Nov 2020
- First submitted
- 15 Dec 2017
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Crossover Study to Evaluate Safety and Efficacy of an Adaptive Deep Brain Stimulation Closed-loop Method Compared With Conventional Deep Brain Stimulation in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03422757
- Acronym / sponsor ID
- NWK_aDBSext_01_2017
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company strategic decision
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NewronikaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 6 Feb 2018 (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.
This is an exploratory study to preliminary assess safety and efficacy of an adaptive Deep Brain Stimulation (DBS) closed-loop method in patients with PD.
The study has been designed as a double blind randomized crossover trial that uses conventional DBS as a concurrent control in PD patients in need of Implantable Pulse Generator (IPG) replacement.
Detailed description
PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment.
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). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adaptive DBS | Experimental | Device: adaptive Deep Brain Stimulationadaptive Deep Brain Stimulation, by AlphaDBSvext. |
| conventional DBS | Active comparator | Device: conventional Deep Brain Stimulationconventional Deep Brain Stimulation, by AlphaDBSvext. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of idiopathic PD;
- DBS implant since at least 3 years and in need of battery replacement, defined by battery level <25%;
- Patients must be able to sign the informed consent document to participate in the clinical trial;
- Patients with a suboptimal response to DBS treatment.
Key exclusion criteria (7 listed)
- Patients with severe cognitive decline (MMSE <25);
- Patients with major psychiatric issues;
- Patients with any medical condition potentially interfering with DBS battery replacement surgery;
- Patients that cannot tolerate an interruption of DBS stimulation;
- Patients taking only one levodopa dose per day;
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 |
|---|---|---|
| adaptive Deep Brain StimulationThe investigational medical device ("AlphaDBSvext") is a portable, external, dual mode stimulator that can deliver adaptive DBS or conventional DBS for the treatment of PD. In the adaptive mode, the device records Local Field Potential activity from the implanted DBS electrode and simultaneously delivers stimulation through the same electrode based on the recorded signal. | Device | adaptive DBS |
| conventional Deep Brain StimulationThe same investigational medical device ("AlphaDBSvext") is used to deliver conventional DBS for the treatment of PD. In the conventional mode it delivers constant stimulation. | Device | conventional DBS |
Primary outcome
Total Electrical Energy Delivered (TEED) to the patient
Time frame: One day.
Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.
3 secondary outcomes
Incidence of device related Adverse Events (safety and tolerability)
Time frame: One day.
Unified Parkinson's Disease Rating Scale (UPDRS) part III
Time frame: One day.
Unified Dyskinesia Rating Scale (UDysRS)
Time frame: One day.
Results and safety
The study was stopped early (reason given: Company strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adaptive Deep Brain Stimulation and conventional Deep Brain Stimulation in people with Parkinson Disease, run by Newronika at 4 sites 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 4 inclusion and 7 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: stopped early, as of the sponsor's last update on 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study was stopped early (reason given: Company strategic decision). Results are not available in the source record.
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?
Total Electrical Energy Delivered (TEED) to the patient (time frame: One day.). 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 19 Nov 2020.