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

Primary Purpose

Parkinson Disease

Status
Terminated
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
adaptive Deep Brain Stimulation
conventional Deep Brain Stimulation
Sponsored by
Newronika
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of idiopathic PD;
  • DBS implant since at least 3 years and in need of battery replacement, defined by battery level <25%;
  • Patients must be able to sign the informed consent document to participate in the clinical trial;
  • Patients with a suboptimal response to DBS treatment.

Exclusion Criteria:

  • Patients with severe cognitive decline (MMSE <25);
  • Patients with major psychiatric issues;
  • Patients with any medical condition potentially interfering with DBS battery replacement surgery;
  • Patients that cannot tolerate an interruption of DBS stimulation;
  • Patients taking only one levodopa dose per day;
  • Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure;
  • Pregnant or breastfeeding women.

Sites / Locations

  • Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO
  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
  • IRCCS Istituto Ortopedico Galeazzi
  • Fondazione Istituto Neurologico Nazionale Casimiro Mondino

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

adaptive DBS

conventional DBS

Arm Description

adaptive Deep Brain Stimulation, by AlphaDBSvext.

conventional Deep Brain Stimulation, by AlphaDBSvext.

Outcomes

Primary Outcome Measures

Total Electrical Energy Delivered (TEED) to the patient
Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.

Secondary Outcome Measures

Incidence of device related Adverse Events (safety and tolerability)
Number of device relate Adverse Events or abnormal vital signs.
Unified Parkinson's Disease Rating Scale (UPDRS) part III
Evaluation of motor symptoms through (UPDRS) part III, motor examination. The total score is computed from scores obtained on 18 items (0 best condition-4 worst condition), some considering multiple body parts.
Unified Dyskinesia Rating Scale (UDysRS)
Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).

Full Information

First Posted
December 15, 2017
Last Updated
November 17, 2020
Sponsor
Newronika
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1. Study Identification

Unique Protocol Identification Number
NCT03422757
Brief Title
Safety and Efficacy of Adaptive DBS Vs Conventional DBS in Patients With Parkinson's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Company strategic decision
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Newronika

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
adaptive DBS
Arm Type
Experimental
Arm Description
adaptive Deep Brain Stimulation, by AlphaDBSvext.
Arm Title
conventional DBS
Arm Type
Active Comparator
Arm Description
conventional Deep Brain Stimulation, by AlphaDBSvext.
Intervention Type
Device
Intervention Name(s)
adaptive Deep Brain Stimulation
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
conventional Deep Brain Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total Electrical Energy Delivered (TEED) to the patient
Description
Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.
Time Frame
One day.
Secondary Outcome Measure Information:
Title
Incidence of device related Adverse Events (safety and tolerability)
Description
Number of device relate Adverse Events or abnormal vital signs.
Time Frame
One day.
Title
Unified Parkinson's Disease Rating Scale (UPDRS) part III
Description
Evaluation of motor symptoms through (UPDRS) part III, motor examination. The total score is computed from scores obtained on 18 items (0 best condition-4 worst condition), some considering multiple body parts.
Time Frame
One day.
Title
Unified Dyskinesia Rating Scale (UDysRS)
Description
Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).
Time Frame
One day.
Other Pre-specified Outcome Measures:
Title
Time "off"
Description
Evaluation of time "off" through patient diary.
Time Frame
One day.
Title
DBS Impairment Scale (DBS-IS)
Description
Self assessment through questionnaire.
Time Frame
One day.
Title
Local field potentials (LFP) during gait analysis
Description
Evaluation of LFP recording from DBS electrodes during gait analysis.
Time Frame
Four hours.
Title
Local field potentials (LFP) during speech analysis
Description
Evaluation of LFP recording from DBS electrodes during speech analysis.
Time Frame
Four hours.
Title
Local field potentials (LFP) during sleep analysis
Description
Evaluation of LFP recording from DBS electrodes during sleep analysis.
Time Frame
One night.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of idiopathic PD; DBS implant since at least 3 years and in need of battery replacement, defined by battery level <25%; Patients must be able to sign the informed consent document to participate in the clinical trial; Patients with a suboptimal response to DBS treatment. Exclusion Criteria: Patients with severe cognitive decline (MMSE <25); Patients with major psychiatric issues; Patients with any medical condition potentially interfering with DBS battery replacement surgery; Patients that cannot tolerate an interruption of DBS stimulation; Patients taking only one levodopa dose per day; Patients with no LFPs recorded from any contacts pair, during intraoperatory IPG replacement procedure; Pregnant or breastfeeding women.
Facility Information:
Facility Name
Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO
City
Milano
Country
Italy
Facility Name
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
IRCCS Istituto Ortopedico Galeazzi
City
Milano
Country
Italy
Facility Name
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
City
Pavia
Country
Italy

12. IPD Sharing Statement

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

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