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

Primary Purpose

Essential Tremor, Parkinson's Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clinician programmer electrode screening mode tool

About this trial

This is an interventional supportive care trial for Essential Tremor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Albany Medical Center
The University of Texas Health Science at San Antonio
Inland Northwest Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Clinician programmer electrode screening mode tool

Outcomes

Primary Outcome Measures

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.

Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit 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.

Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline

Secondary Outcome Measures

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.

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.

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.

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.

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.

Mean Duration of Programming

Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment

Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months

Change in TEED at the 3-month follow-up visit 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

Full Information

NCT ID

NCT03794661

First Posted

December 18, 2018

Last Updated

March 28, 2022

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT03794661

Brief Title

Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

Acronym

EVIDENT

Official Title

Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

June 26, 2019 (Actual)

Primary Completion Date

December 16, 2020 (Actual)

Study Completion Date

December 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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).

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Essential Tremor, Parkinson's Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Masking Description

Outcomes assessor will be masked to subjects' deep brain stimulation programming.

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm

Arm Type

Experimental

Arm Description

Clinician programmer electrode screening mode tool

Intervention Type

Device

Intervention Name(s)

Clinician programmer electrode screening mode tool

Other Intervention Name(s)

Informity tool

Intervention Description

Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process

Primary Outcome Measure Information:

Title

Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline

Description

Time Frame

At Day 21 compared to baseline

Title

Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline

Description

Time Frame

At Day 21 compared to baseline

Title

Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline

Description

Time Frame

At Day 21 compared to baseline

Title

Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline

Description

Time Frame

At Day 21 compared to baseline

Secondary Outcome Measure Information:

Title

Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months

Description

Time Frame

At 3 months compared to baseline

Title

Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months

Description

Time Frame

At 6 months compared to baseline

Title

Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline

Description

Time Frame

At baseline

Title

Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months

Description

Time Frame

At 3 months

Title

Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months

Description

Time Frame

At 6 months

Title

Mean Duration of Programming

Description

Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment

Time Frame

At Day 21

Title

Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months

Description

Change in TEED at the 3-month follow-up visit compared to baseline

Time Frame

At 3 months compared to baseline

Title

Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months

Description

Change in TEED at the 6-month follow-up visit compared to baseline

Time Frame

At 6 months compared to baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bradley White

Organizational Affiliation

Abbott

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Binith Cheeran

Organizational Affiliation

Abbott Medical Devices Neuromodulation

Official's Role

Study Director

Facility Information:

Facility Name

Albany Medical Center

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Facility Name

The University of Texas Health Science at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Inland Northwest Research

City

Spokane

State/Province

Washington

ZIP/Postal Code

99202

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

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