Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool (EVIDENT)

• ClinicalTrials.gov Identifier: NCT03794661
• Recruitment Status: Completed
• First Posted: January 7, 2019
• Results First Posted: March 31, 2022
• Last Update Posted: March 31, 2022
• Sponsor: Abbott Medical Devices
• Information provided by (Responsible Party): Abbott Medical Devices

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Essential Tremor; Parkinson's Disease	Device: Clinician programmer electrode screening mode tool	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: N/A
• 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 26, 2019
• Actual Primary Completion Date: December 16, 2020
• Actual Study Completion Date: December 16, 2020

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline [ Time Frame: At Day 21 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.
2. Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline [ Time Frame: At Day 21 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.
3. Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline [ Time Frame: At Day 21 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.
4. Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline [ Time Frame: At Day 21 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.

Secondary Outcome Measures :

1. Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months [ Time Frame: At 3 months compared to baseline ]
   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.
2. Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months [ Time Frame: At 6 months compared to baseline ]
   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.
3. Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline [ Time Frame: 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.
4. Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months [ Time Frame: 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.
5. Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months [ Time Frame: 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.
6. Mean Duration of Programming [ Time Frame: At Day 21 ]
   Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment
7. Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months [ Time Frame: At 3 months compared to baseline ]
   Change in TEED at the 3-month follow-up visit compared to baseline
8. Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months [ Time Frame: At 6 months compared to baseline ]
   Change in TEED at the 6-month follow-up visit compared to baseline

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

INCLUSION CRITERIA

Parkinson's disease patients:

1. Patient must provide written informed consent prior to any clinical study related procedure.
2. Patient is 18 to 80 years of age.
3. Patient is diagnosed with Parkinson's disease for at least 4 years according to standard practice.
4. 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.
5. Patient is willing and able to comply with the follow-up schedule for the length of the study.
6. Patient has been implanted with an 8-channel directional Infinity deep brain stimulation system in the subthalamic nucleus (STN) within the last 12 months.
7. Patient has had stable deep brain stimulation programming settings for at least 1 month prior to study enrollment.

Essential tremor patients:

1. Patient must provide written informed consent prior to any clinical study related procedure.
2. Patient is 18 to 80 years of age.
3. Patient is diagnosed with essential tremor for at least 4 years according to standard practice.
4. 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.
5. Patient is willing and able to comply with the follow-up schedule for the length of the study.
6. 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.
7. Patient has had stable deep brain stimulation programming settings for at least 1 month prior to study enrollment.

EXCLUSION CRITERIA

1. Individuals unable to make the decision to participate in a clinical investigation on their own.
2. Patient is currently programmed with segmented electrodes, and cannot tolerate omnidirectional programming.
3. Patient is being evaluated for a lead revision.
4. Patient has untreated clinically significant depression.
5. 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.
6. Patient abuses drugs or alcohol.
7. Patient is currently enrolled or plans to enroll in another concurrent study that may confound the results of this clinical investigation.
8. Patient has a confirmation of diagnosis of a terminal illness associated with survival <12 months.
9. 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.
10. Pregnant or nursing patients and those who plan pregnancy during the clinical study follow-up period.

Contacts and Locations

Locations

United States, New York

Albany Medical Center

Albany, New York, United States, 12208

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

Sponsors and Collaborators

Abbott Medical Devices

Investigators

• Study Chair: Bradley White; Abbott
• Study Director: Binith Cheeran; Abbott Medical Devices Neuromodulation

  Study Documents (Full-Text)

Documents provided by Abbott Medical Devices:

Study Protocol and Statistical Analysis Plan  [PDF] April 8, 2020

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03794661
• Other Study ID Numbers: ABT-CIP-10245
• First Posted: January 7, 2019
• Results First Posted: March 31, 2022
• Last Update Posted: March 31, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Parkinson Disease; Essential Tremor; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases