Safety and Efficacy of Adaptive Deep Brain Stimulation

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681534
• Other study ID #: NWK_AlphaDBS_FIM_2019
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2022
• Source: Newronika
• Contact: Costanza Conti, PhD
• Phone: +39 02 84 109 381
• Email: costanza.conti[@]newronika.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) for DBS, at the time of IPG replacement.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan
Italy	IRCCS Istituto Neurologico Carlo Besta	Milan
Italy	AOU Città della Salute e della Scienza di Torino	Turin
Poland	Copernicus Podmiot Leczniczy	Gdansk
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Newronika

Countries where clinical trial is conducted

Italy,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of the "AlphaDBS" System, when used in cDBS and aDBS mode	Occurrence of device related adverse events	1 month
Primary	Change in the TEED to the patient	Change in the Total Electrical Energy Delivered (TEED) to the patient	1 month
Secondary	PD-related motor symptoms and their fluctuations	Evaluation of PD-related motor symptoms using the Unified Parkinson's Disease Rating Scale - UPDRS Part III.	1 month
Secondary	Dyskinesia	Evaluation of dyskinesia and their fluctuations through repeated clinical assessments using the Unified Dyskinesia Rating Scale - UDysRS	1 month
Secondary	Dyskinesia	Evaluation of the performance of a wearable accelerometer in detecting dyskinesia (compared to patient reported dyskinesia in the patient diary)	up to 1 month
Secondary	"Time on" with and without dyskinesia	Evaluation of "time on" with and without dyskinesia, assessed through Patient Diary	1 month
Secondary	"Time off"	Evaluation of "time off", assessed through Patient Diary	1 month
Secondary	Patient controller usability	Usability will be evaluated by means of a usability questionnaire	1 month
Secondary	Usability of the system for the physician	Usability will be evaluated by means of a usability questionnaire	1 month