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
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Device: Omnidirectional stimulation Device: Directional stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||234 participants|
|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.|
|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|
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.
- 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.
- 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.
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, Institute for Clinical Neuroscience|
|Principal Investigator:||Jan Vesper, MD||Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery|