Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System (PROGRESS)

  • STATUS
    Enrolling By Invitation
  • participants needed
    6
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Updated on 19 February 2024

Summary

You are being invited to participate in a research study because you have been diagnosed with Parkinson’s disease (PD) and you underwent or have been offered a procedure called Deep Brain Stimulation (DBS) as a treatment option to manage some of your symptoms of Parkinson’s disease. The purpose of this study is to support the routine clinical performance of the Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) and related system components. The Infinity™ DBS system has been approved for commercial market in the United States, however, this system includes a unique ability to deliver stimulation in a more controlled fashion. This study seeks to determine if directional lead DBS programming has a larger therapeutic effect than omnidirectional lead DBS programming.

Description

If you agree to take part in the research study, your involvement will last approximately 12 months. You will be asked to return to the clinic for scheduled visits after your initial programming visit. In order to evaluate the effectiveness of the Infinity™ DBS system, a variety of assessments and questionnaires will be administered. Study visits are: Enrollment/Baseline Visit, Initial Programming Visit, 3-Month Follow-Up Visit, 6-Month Follow-Up Visit, and 12-Month Follow-Up Visit. Implant day (i.e. DBS procedure day) is not considered as a research visit.

FAQ

Your participation is voluntary which means you can choose whether or not you want to participate. If you choose not to participate, there will be no loss of benefits to which you are otherwise entitled. Reimbursement is to help cover the costs of travel and meal expenses associated with your participation in the study. If you do not finish the study, you will only be paid for the visits you have completed.

Details
Condition Parkinson's disease,parkinson's disease
Age 18years - 100years
Clinical Study IdentifierTX5097
Last Modified on19 February 2024

Eligibility

If you need help finding a study or have any questions, please contact us at psom-ocr@pobox.upenn.edu

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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