Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool (EVIDENT)
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|ClinicalTrials.gov Identifier: NCT03794661|
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : January 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor Parkinson's Disease||Device: Clinician programmer electrode screening mode tool||Not Applicable|
This is a prospective, non-randomized, single-arm, multi-center, post-market clinical investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.
This clinical investigation will be conducted at up to 5 centers in the United States.
Up to 40 patients will be enrolled in the study. Of these subjects, up to 20 will have PD and up to 20 will have ET. All patients will have received Infinity DBS systems prior to enrolling in the study.
Subjects participating in this clinical investigation will be followed for 6 months. The expected duration of enrollment is 6 months. The total duration of the clinical investigation is expected to be 18 months. The primary and secondary endpoints will be evaluated when all subjects have completed their 6 month follow-up visits
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Outcomes assessor will be masked to subjects' deep brain stimulation programming.|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool|
|Actual Study Start Date :||June 27, 2019|
|Actual Primary Completion Date :||December 16, 2020|
|Actual Study Completion Date :||December 16, 2020|
Experimental: Single Arm
Clinician programmer electrode screening mode tool
Device: Clinician programmer electrode screening mode tool
Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Other Name: Informity tool
- Therapeutic window size between side effect amplitude and therapeutic benefit amplitude [ Time Frame: Change from Baseline at Day 21 ]Change in therapeutic window size at the informity programming visit compared to baseline. The therapeutic window measures the difference between the stimulation amplitude that generates side effects and the stimulation amplitude that generates therapeutic benefit.
- Therapeutic electrical energy delivered (TEED) [ Time Frame: Change from Baseline at Day 21 ]Change in therapeutic electrical energy delivered (TEED) at the informity programming visit compared to baseline. TEED measures the total energy delivered by the deep brain stimulation system over an arbitrary period of time, and is determined by the programmed stimulation parameters and measured system impedance.
- Motor symptom evaluation for PD or ET subjects [ Time Frame: Change from Baseline at 3 and 6-month follow-up visits ]Change in UPDRS III for PD subjects or Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3- and 6-month follow-up visits compared to baseline. UPDRS III scores range from 0 to 56, and lower scores indicate less severe motor symptoms. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.
- Quality of life assessment for PD subjects [ Time Frame: Change from Baseline at 3 and 6-month follow-up visits ]Change in quality of life measurement as measured by the Parkinson's Disease Questionnaire (PDQ)-39 for PD subjects or QUEST for ET subjects at the 3- and 6-month follow-up visits compared to baseline. PDQ-39 scores range from 0 to 100, and lower scores reflect a better quality of life.
- Duration of programming [ Time Frame: Day 21 ]Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment
- Therapeutic electrical energy delivered (TEED) [ Time Frame: Change from Baseline at 3 and 6-month follow-up visits ]Change in TEED at the 3- and 6-month follow-up visits compared to baseline
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): NCT03794661
|United States, New York|
|Albany Medical Center|
|Albany, New York, United States, 12208|
|United States, Ohio|
|The Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Texas|
|The University of Texas Health Science at San Antonio|
|San Antonio, Texas, United States, 78229|
|United States, Washington|
|Inland Northwest Research|
|Spokane, Washington, United States, 99202|
|Study Chair:||Bradley White||Abbott|
|Study Chair:||Florence Defresne||Abbott|
|Study Director:||Edward Karst||Abbott Neuromodulation|