Trials / Terminated
TerminatedNCT03422757
Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease
A Double Blind, Crossover Study to Evaluate Safety and Efficacy of an Adaptive Deep Brain Stimulation Closed-loop Method Compared With Conventional Deep Brain Stimulation in Patients With Parkinson's Disease
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 6 (actual)
- Sponsor
- Newronika · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
PD patients in need of IPG replacement will be screened to identify the ones eligible for enrollment. 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). During each experimental session experienced neurologists will collect information on safety and efficacy endpoints.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2017-06-01
- Primary completion
- 2018-12-30
- Completion
- 2018-12-30
- First posted
- 2018-02-06
- Last updated
- 2020-11-19
Locations
4 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT03422757. Inclusion in this directory is not an endorsement.