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Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease

NCT03422757 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-11-19

No results posted yet for this study

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 Pulse Generator (IPG) replacement.

Conditions

  • Parkinson Disease

Interventions

DEVICE

adaptive Deep Brain Stimulation

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.

DEVICE

conventional Deep Brain Stimulation

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.

Sponsors & Collaborators

  • Newronika

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-01
Primary Completion
2018-12-30
Completion
2018-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03422757 on ClinicalTrials.gov