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Safety and Efficacy of Adaptive Deep Brain Stimulation

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

AlphaDBS System

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
IRCCS Istituto Neurologico Carlo Besta
AOU Città della Salute e della Scienza di TorinoRecruiting
Copernicus Podmiot Leczniczy
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut BadawczyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional DBS

adaptive DBS

Arm Description

Outcomes

Primary Outcome Measures

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

Occurrence of device related adverse events

Change in the TEED to the patient

Change in the Total Electrical Energy Delivered (TEED) to the patient

Secondary Outcome Measures

PD-related motor symptoms and their fluctuations

Evaluation of PD-related motor symptoms using the Unified Parkinson's Disease Rating Scale - UPDRS Part III.

Dyskinesia

Evaluation of dyskinesia and their fluctuations through repeated clinical assessments using the Unified Dyskinesia Rating Scale - UDysRS

Dyskinesia

Evaluation of the performance of a wearable accelerometer in detecting dyskinesia (compared to patient reported dyskinesia in the patient diary)

"Time on" with and without dyskinesia

Evaluation of "time on" with and without dyskinesia, assessed through Patient Diary

"Time off"

Evaluation of "time off", assessed through Patient Diary

Patient controller usability

Usability will be evaluated by means of a usability questionnaire

Usability of the system for the physician

Usability will be evaluated by means of a usability questionnaire

Full Information

NCT ID

NCT04681534

First Posted

November 20, 2020

Last Updated

February 4, 2022

Sponsor

Newronika

1. Study Identification

Unique Protocol Identification Number

NCT04681534

Brief Title

Safety and Efficacy of Adaptive Deep Brain Stimulation

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 26, 2021 (Actual)

Primary Completion Date

September 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Newronika

4. Oversight

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.

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

conventional DBS

Arm Type

Active Comparator

Arm Title

adaptive DBS

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

AlphaDBS System

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Occurrence of device related adverse events

Time Frame

1 month

Title

Change in the TEED to the patient

Description

Change in the Total Electrical Energy Delivered (TEED) to the patient

Time Frame

1 month

Secondary Outcome Measure Information:

Title

PD-related motor symptoms and their fluctuations

Description

Evaluation of PD-related motor symptoms using the Unified Parkinson's Disease Rating Scale - UPDRS Part III.

Time Frame

1 month

Title

Dyskinesia

Description

Evaluation of dyskinesia and their fluctuations through repeated clinical assessments using the Unified Dyskinesia Rating Scale - UDysRS

Time Frame

1 month

Title

Dyskinesia

Description

Evaluation of the performance of a wearable accelerometer in detecting dyskinesia (compared to patient reported dyskinesia in the patient diary)

Time Frame

up to 1 month

Title

"Time on" with and without dyskinesia

Description

Evaluation of "time on" with and without dyskinesia, assessed through Patient Diary

Time Frame

1 month

Title

"Time off"

Description

Evaluation of "time off", assessed through Patient Diary

Time Frame

1 month

Title

Patient controller usability

Description

Usability will be evaluated by means of a usability questionnaire

Time Frame

1 month

Title

Usability of the system for the physician

Description

Usability will be evaluated by means of a usability questionnaire

Time Frame

1 month

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Costanza Conti, PhD

Phone

+39 02 84 109 381

costanza.conti@newronika.com

Facility Information:

Facility Name

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

City

Milan

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Elena Pirola, MD

Facility Name

IRCCS Istituto Neurologico Carlo Besta

City

Milan

Country

Italy

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roberto Eleopra, MD

Facility Name

AOU Città della Salute e della Scienza di Torino

City

Turin

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michele Lanotte, MD

Facility Name

Copernicus Podmiot Leczniczy

City

Gdańsk

Country

Poland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Witold Libionka, MD

Facility Name

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

City

Warsaw

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tomasz Mandat, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34980610

Citation

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.

Results Reference

derived

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Safety and Efficacy of Adaptive Deep Brain Stimulation

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