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Clinical Evaluation of the Infinity Deep Brain Stimulation System (PROGRESS)

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ClinicalTrials.gov Identifier: NCT02989610
Recruitment Status : Active, not recruiting
First Posted : December 12, 2016
Results First Posted : November 19, 2020
Last Update Posted : November 19, 2020
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) system, including the Implantable Pulse Generator (IPG), directional 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)
Actual Enrollment : 234 participants
Allocation: N/A
Intervention Model: Crossover Assignment
Intervention Model Description:

Single-arm crossover study, with double-blind, randomized sequence of testing for primary endpoint.

Although this was a crossover study, the primary endpoint was a double-blind randomized controlled assessment of therapeutic window during the 3-month clinic visit. Subjects received both directional and omnidirectional stimulation, and the order was randomized.

Masking: None (Open Label)
Masking Description: Single-arm, open-label design for overall study. Primary endpoint is based on double-blind, randomized testing of omnidirectional and directional DBS during three-month follow visit. Participants are blinded to all details of stimulation for first six months, including details of stimulation testing. Outcomes assessor is blinded to stimulation type for primary and secondary endpoints.
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
Actual Primary Completion Date : August 7, 2019
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Omnidirectional followed by directional DBS
Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for months 3-6 in all subjects with a directional DBS lead. Primary endpoint is based on double-blind testing of omnidirectional vs. directional DBS in randomized order at 3-month follow-up visit.
Device: Omnidirectional stimulation
At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional stimulation with the Infinity DBS lead.

Device: Directional stimulation
At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated using directional contacts at the best segmented level of the Infinity DBS lead.




Primary Outcome Measures :
  1. Percentage of Participants With Wider Therapeutic Window With Directional Programming (Superiority) [ Time Frame: 3-month follow-up visit after initial programming ]
    Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.


Secondary Outcome Measures :
  1. Percentage of Participants With Wider Therapeutic Window With Directional Programming (Non-inferiority) [ Time Frame: 3-month follow-up visit after initial programming ]
    Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control.

  2. Change in UPDRS III Score on and Off Stimulation (Medication on) at 3 and 6 Months [ Time Frame: 3-month and 6-month follow-up visits ]
    Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment.



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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
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Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Principal Investigator: Alfons Schnitzler, MD Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience
Principal Investigator: Jan Vesper, MD Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:
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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
Results First Posted: November 19, 2020
Last Update Posted: November 19, 2020
Last Verified: October 2020
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