Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System (PROGRESS)
Enrolling By Invitation
18 years - 100 years
All
Phase
4
6 participants needed
1 Location
Brief description of study
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.
Detailed description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Parkinson's disease,parkinson's disease
-
Age: 18 years - 100 years
-
Gender: All
Updated on
19 Feb 2024.
Study ID: 827117
If you need help finding a study or have any questions, please contact us at psom-ocr@pobox.upenn.edu
