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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

Tracking Information
First Submitted Date  ICMJE December 8, 2016
First Posted Date  ICMJE December 12, 2016
Results First Submitted Date  ICMJE September 4, 2020
Results First Posted Date  ICMJE November 19, 2020
Last Update Posted Date November 19, 2020
Actual Study Start Date  ICMJE January 31, 2017
Actual Primary Completion Date August 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2016)
Therapeutic Window Evaluation [ Time Frame: 3 month visit ]
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 60% at the 3-month follow-up visit.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2020)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Evaluation of the Infinity Deep Brain Stimulation System
Official Title  ICMJE Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • 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.
Study Arms  ICMJE 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.
Interventions:
  • Device: Omnidirectional stimulation
  • Device: Directional stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 11, 2020)
234
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2016)
350
Estimated Study Completion Date  ICMJE March 2022
Actual Primary Completion Date August 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Germany,   Italy,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02989610
Other Study ID Numbers  ICMJE SJM-CIP-10061
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Abbott Medical Devices
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP