Clinical Evaluation of the Infinity DBS System (PROGRESS)
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|ClinicalTrials.gov Identifier: NCT02989610|
Recruitment Status : Active, not recruiting
First Posted : December 12, 2016
Last Update Posted : February 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Omnidirectional stimulation Device: Directional stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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.
- 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%
- 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%
- 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.
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
|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|