Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

Study Overview
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Brief Summary
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The objective of this clinical investigation is to characterize the clinical performance of Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or essential tremor (ET).

Detailed Description
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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 were intended to enroll in the study. However the study was stopped after enrolling 8 subjects at 3 sites. 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

Official Title
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Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

Conditions
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Essential Tremor, Parkinson's Disease

Intervention / Treatment
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* Device: Clinician programmer electrode screening mode tool


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA Parkinson's disease patients: Patient must provide written informed consent prior to any clinical study related procedure. Patient is 18 to 80 years of age. Patient is diagnosed with Parkinson's disease for at least 4 years according to standard practice. Patient is willing to maintain a constant dose of anti-Parkinson's disease medication indicated as best medical management for at least 1 month prior to study enrollment. Patient is willing and able to comply with the follow-up schedule for the length of the study. Patient has been implanted with an 8-channel directional Infinity deep brain stimulation system in the subthalamic nucleus (STN) within the last 12 months. Patient has had stable deep brain stimulation programming settings for at least 1 month prior to study enrollment. Essential tremor patients: Patient must provide written informed consent prior to any clinical study related procedure. Patient is 18 to 80 years of age. Patient is diagnosed with essential tremor for at least 4 years according to standard practice. Patient is willing to maintain a constant dose of anti-tremor medication indicated as best medical management for at least 1 month prior to study enrollment. Patient is willing and able to comply with the follow-up schedule for the length of the study. Patient has been implanted with an 8-channel directional Infinity deep brain stimulation system in the ventral intermediate (Vim) thalamus within the last 12 months. Patient has had stable deep brain stimulation programming settings for at least 1 month prior to study enrollment. EXCLUSION CRITERIA Individuals unable to make the decision to participate in a clinical investigation on their own. Patient is currently programmed with segmented electrodes, and cannot tolerate omnidirectional programming. Patient is being evaluated for a lead revision. Patient has untreated clinically significant depression. Patient has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the informed consent, as determined by the investigator. Patient abuses drugs or alcohol. Patient is currently enrolled or plans to enroll in another concurrent study that may confound the results of this clinical investigation. Patient has a confirmation of diagnosis of a terminal illness associated with survival <12 months. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the patient's ability to participate in the clinical study or to comply with follow-up requirements, or impact the scientific soundness of the clinical study results. Pregnant or nursing patients and those who plan pregnancy during the clinical study follow-up period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Clinician programmer electrode screening mode tool | Device: Clinician programmer electrode screening mode tool<br>* Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process<br>* Other names: Informity tool;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline | Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing. | At Day 21 compared to baseline | 
| Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline | Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing. | At Day 21 compared to baseline | 
| Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline | TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing. | At Day 21 compared to baseline | 
| Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline | TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing. | At Day 21 compared to baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months | Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. 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. | At 3 months compared to baseline | 
| Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months | Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. 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. | At 6 months compared to baseline | 
| Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline | Mean quality of life will be measured by the QUEST for ET subjects at baseline. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | At baseline | 
| Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months | Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | At 3 months | 
| Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months | Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life. | At 6 months | 
| Mean Duration of Programming | Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment | At Day 21 | 
| Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months | Change in TEED at the 3-month follow-up visit compared to baseline | At 3 months compared to baseline | 
| Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months | Change in TEED at the 6-month follow-up visit compared to baseline | At 6 months compared to baseline |