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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03422757
Recruitment Status : Terminated (Company strategic decision)
First Posted : February 6, 2018
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Newronika

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Device: adaptive Deep Brain Stimulation Device: conventional Deep Brain Stimulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: adaptive DBS
adaptive Deep Brain Stimulation, by AlphaDBSvext.
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.


Active Comparator: conventional DBS
conventional Deep Brain Stimulation, by AlphaDBSvext.
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.




Primary Outcome Measures :
  1. Total Electrical Energy Delivered (TEED) to the patient [ Time Frame: One day. ]
    Difference in the TEED delivered to the patient in adaptive DBS versus conventional DBS mode.


Secondary Outcome Measures :
  1. Incidence of device related Adverse Events (safety and tolerability) [ Time Frame: One day. ]
    Number of device relate Adverse Events or abnormal vital signs.

  2. Unified Parkinson's Disease Rating Scale (UPDRS) part III [ Time Frame: One day. ]
    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.

  3. Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: One day. ]
    Evaluation of dyskinesia through repeated clinical assessments (using UDysRS).


Other Outcome Measures:
  1. Time "off" [ Time Frame: One day. ]
    Evaluation of time "off" through patient diary.

  2. DBS Impairment Scale (DBS-IS) [ Time Frame: One day. ]
    Self assessment through questionnaire.

  3. Local field potentials (LFP) during gait analysis [ Time Frame: Four hours. ]
    Evaluation of LFP recording from DBS electrodes during gait analysis.

  4. Local field potentials (LFP) during speech analysis [ Time Frame: Four hours. ]
    Evaluation of LFP recording from DBS electrodes during speech analysis.

  5. Local field potentials (LFP) during sleep analysis [ Time Frame: One night. ]
    Evaluation of LFP recording from DBS electrodes during sleep analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03422757


Locations
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Italy
Centro Parkinson e Disturbi del Movimento ASST G.Pini- CTO
Milano, Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milano, Italy
IRCCS Istituto Ortopedico Galeazzi
Milano, Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
Pavia, Italy
Sponsors and Collaborators
Newronika
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Responsible Party: Newronika
ClinicalTrials.gov Identifier: NCT03422757    
Other Study ID Numbers: NWK_aDBSext_01_2017
First Posted: February 6, 2018    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases