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Clinical Evaluation of the Infinity DBS System (PROGRESS)

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: NCT02989610
Recruitment Status : Active, not recruiting
First Posted : December 12, 2016
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Brief Summary:
The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG), DBS leads, extensions, iPad clinician programmer, iPod patient controller and related system components.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: Omnidirectional stimulation Device: Directional stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Omnidirectional stimulation
Omnidirectional DBS is tested in all subjects.
Device: Omnidirectional stimulation
Symptom relief and side effect thresholds will be evaluated using omnidirectional stimulation with the DBS lead.

Active Comparator: Directional stimulation
Directional DBS is tested in subjects with a directional DBS lead.
Device: Directional stimulation
Symptom relief and side effect thresholds will be evaluated using directional contacts of the DBS lead.




Primary Outcome Measures :
  1. Therapeutic Window Evaluation [ Time Frame: 3 month follow-up visit ]
    The proportion of subjects for which at least one lead's therapeutic window (evaluated by a blinded evaluator) is greater using directional stimulation than omnidirectional stimulation, tested against a performance goal of 60%


Secondary Outcome Measures :
  1. Therapeutic Window Evaluation [ Time Frame: 3 month follow-up visit ]
    If primary endpoint not met, the proportion of subjects with a therapeutic window (evaluated by a blinded evaluator) which is larger under directional stimulation than omnidirectional stimulation tested against a performance goal of 40%

  2. Compare UPDRS Motor Scores [ Time Frame: 3 and 6 month follow-up visits ]
    Comparison of 3-month vs. 6-month Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination scores (evaluated by a blinded evaluator) to assess omnidirectional vs. directional stimulation. UPDRS measures severity and impact of Parkinson's disease. Part III motor examination contains 27 questions used to measures severity of motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is able to provide informed consent;
  • Subject is diagnosed with Parkinson's disease (PD) and has been recommended to receive an Infinity DBS system with a bilateral DBS implant in the Subthalamic Nucleus (STN), or has received an implant of an Infinity system with bilateral lead implants in the STN;
  • Subject must be available for follow-up visits.

Exclusion Criteria:

  • Subject is not a surgical candidate;
  • In the investigator's opinion, the subject is unable to tolerate multiple programming sessions within a single setting;
  • Subject is unable to comply with the follow-up schedule.

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): NCT02989610


Locations
Show Show 33 study locations
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Alfons Schnitzler, MD Heinrich-Heine-Universität Düsseldorf, Institut für Klinische Neurowissenschaften und Medizinische Psychologie
Principal Investigator: Jan Vesper, MD Heinrich-Heine-Universität Düsseldorf, Department of Functional Neurosurgery and Stereotaxy

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Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT02989610    
Other Study ID Numbers: SJM-CIP-10061
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
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
Neurodegenerative Diseases