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Safety and Efficacy of Adaptive Deep Brain Stimulation

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ClinicalTrials.gov Identifier: NCT04681534
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : September 1, 2021
Sponsor:
Information provided by (Responsible Party):
Newronika

Study Description
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Brief 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) for DBS, at the time of IPG replacement.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: AlphaDBS System Not Applicable

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 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 26, 2021
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: conventional DBS Device: AlphaDBS System
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.
Experimental: adaptive DBS Device: AlphaDBS System
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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode [ Time Frame: 1 month ]
    Occurrence of device related adverse events

  2. Change in the TEED to the patient [ Time Frame: 1 month ]
    Change in the Total Electrical Energy Delivered (TEED) to the patient


Secondary Outcome Measures :
  1. PD-related motor symptoms and their fluctuations [ Time Frame: 1 month ]
    Evaluation of PD-related motor symptoms using the Unified Parkinson's Disease Rating Scale - UPDRS Part III.

  2. Dyskinesia [ Time Frame: 1 month ]
    Evaluation of dyskinesia and their fluctuations through repeated clinical assessments using the Unified Dyskinesia Rating Scale - UDysRS

  3. Dyskinesia [ Time Frame: up to 1 month ]
    Evaluation of the performance of a wearable accelerometer in detecting dyskinesia (compared to patient reported dyskinesia in the patient diary)

  4. "Time on" with and without dyskinesia [ Time Frame: 1 month ]
    Evaluation of "time on" with and without dyskinesia, assessed through Patient Diary

  5. "Time off" [ Time Frame: 1 month ]
    Evaluation of "time off", assessed through Patient Diary

  6. Patient controller usability [ Time Frame: 1 month ]
    Usability will be evaluated by means of a usability questionnaire

  7. Usability of the system for the physician [ Time Frame: 1 month ]
    Usability will be evaluated by means of a usability questionnaire


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of idiopathic PD;
  2. Subject is bilaterally treated with DBS in the STN using a Medtronic Activa PC or Activa RC IPG (mono-channnel or dual channel);
  3. DBS implant for at least 3 years and in need of battery replacement within 12 months after consent;
  4. Patients must be able to understand and sign the informed consent document

Exclusion Criteria:

  1. Patients with severe cognitive decline, as resulting from MoCA assessment (MoCA score < 10);
  2. 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.);
  3. 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.);
  4. Need to replace or reposition the leads during the IPG replacement procedure;
  5. Patients with > 10 recurrent falls experienced in the 3 months prior to consent;
  6. Patients that cannot tolerate an interruption of DBS stimulation for at least 30 min;
  7. Patients taking less than one levodopa dose per day;
  8. Patients without suitable LFPs recordings or with significant artifacts;
  9. Pregnant or breastfeeding women.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681534


Contacts
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Contact: Costanza Conti, PhD +39 02 84 109 381 costanza.conti@newronika.com

Locations
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Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Not yet recruiting
Milan, Italy
Contact: Elena Pirola, MD         
IRCCS Istituto Neurologico Carlo Besta Not yet recruiting
Milan, Italy
Contact: Roberto Eleopra, MD         
AOU Città della Salute e della Scienza di Torino Recruiting
Turin, Italy
Contact: Michele Lanotte, MD         
Poland
Copernicus Podmiot Leczniczy Not yet recruiting
Gdańsk, Poland
Contact: Witold Libionka, MD         
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy Recruiting
Warsaw, Poland
Contact: Tomasz Mandat, MD         
Sponsors and Collaborators
Newronika
More Information
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Responsible Party: Newronika
ClinicalTrials.gov Identifier: NCT04681534    
Other Study ID Numbers: NWK_AlphaDBS_FIM_2019
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases