Safety and Efficacy of Adaptive Deep Brain Stimulation

NCT04681534 | Recruiting

• 1 other identifier: NWK_AlphaDBS_FIM_2019
• Study Type: interventional
• Target: 15
• Locations: 3 countries
• Sites: 8

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode

  Occurrence of device related adverse events

  1 month

Secondary Outcomes (8)

• PD-related motor symptoms and their fluctuations

  1 month

• Dyskinesia

  1 month

• Dyskinesia

  up to 1 month

• "Time on" with and without dyskinesia

  1 month

• "Time off"

  1 month

Study Arms (2)

conventional DBS

ACTIVE COMPARATOR

Device: AlphaDBS System

adaptive DBS

EXPERIMENTAL

Device: AlphaDBS System

Interventions

AlphaDBS System DEVICE

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.

adaptive DBS; conventional DBS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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 is ≥ 18 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 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;

Sponsors & Collaborators

• Newronika: lead

Study Sites (8)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

IRCCS Istituto Neurologico Carlo Besta

Milan, Italy

COMPLETED

Azienda Ospedale Universitario di Padova - Università di Padova

Padua, Italy

WITHDRAWN

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

COMPLETED

AOU Città della Salute e della Scienza di Torino

Turin, Italy

COMPLETED

Maastricht Medical Center

Maastricht, Netherlands

WITHDRAWN

Copernicus Podmiot Leczniczy

Gdansk, Poland

WITHDRAWN

Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

Warsaw, Poland

COMPLETED

Related Publications (1)

• 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.

  PMID: 34980610 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Costanza Conti, PhD

CONTACT

+39 02 84 109 381; costanza.conti@newronika.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: December 23, 2020
• Study Start: January 26, 2021
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5); NL (1); PL (2)