Essential TremorEVIDENTNCT03794661

Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

A study testing Clinician programmer electrode screening mode tool in people with Essential Tremor and Parkinson's Disease, run by Abbott Medical Devices at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Essential Tremor, Parkinson's Disease
What is being tested?: Clinician programmer electrode screening mode tool
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 3 sitesUnited States
Study dates: 26 Jun 2019to 16 Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Albany Medical Center
Albany, New York, 12208
The University of Texas Health Science at San Antonio
San Antonio, Texas, 78229
Inland Northwest Research
Spokane, Washington, 99202

Other trials in United States

About this study

Read the 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

Conditions: Essential Tremor, Parkinson's Disease
Being tested: Clinician programmer electrode screening mode tool
Medical subject headings: Essential Tremor, Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Clinician programmer electrode screening mode toolDevice
Also called Informity tool
Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process

Study groups in NCT03794661
Study group	Role	What they receive
Single Arm	Experimental	Clinician programmer electrode screening mode tool Receives: Device: Clinician programmer electrode screening mode tool

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 21 compared to baseline

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: At 6 months compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 201916 Dec 2020

First posted7 Jan 2019
Study start26 Jun 2019
Primary completion16 Dec 2020
Study completion16 Dec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Essential TremorStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03794661
Sponsor's protocol ID: ABT-CIP-10245
Acronym: EVIDENT
Status last verified: Mar 2022
First submitted: 18 Dec 2018
Last updated: 31 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
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All Essential Tremor trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
ClinicalTrials.gov ID: NCT03794661
Acronym / sponsor ID: EVIDENT / ABT-CIP-10245
Conditions: Essential Tremor, Parkinson's Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: 26 Jun 2019 (actual)
Primary completion: 16 Dec 2020 (actual)
Study completion: 16 Dec 2020 (actual)
First posted: 7 Jan 2019 (actual)
Results: Posted 31 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Device: Clinician programmer electrode screening mode toolClinician programmer electrode screening mode tool

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Clinician programmer electrode screening mode toolAlso: Informity toolProvides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process	Device	Single Arm

Primary outcome

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.
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.
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.
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.

8 secondary outcomes

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
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
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 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 for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months
Time frame: At 6 months
Mean Duration of Programming
Time frame: At Day 21
Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months
Time frame: At 3 months compared to baseline
Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months
Time frame: At 6 months compared to baseline

Results and safety

Results posted to the registry on 31 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm	8	8

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

Time frame: At Day 21 compared to baseline. Mean (Standard Deviation). Unit: milliampere (mA)

Measure	Single Arm n = 8
Baseline	1.37 (1.48)
Informity Programming	1.80 (1.35)

Population analysed: The number of participants analyzed includes subjects who were available at that time of analysis

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

Time frame: At Day 21 compared to baseline. Mean (Standard Deviation). Unit: milliampere (mA)

Measure	Single Arm n = 8
Baseline	1.37 (1.48)
Informity Programming	2.34 (1.29)

Population analysed: The number of participants analyzed includes subjects who were available at that time of analysis

Primary outcome: 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. Mean (Standard Deviation). Unit: microjoule (μJ)

Measure	Single Arm n = 8
Baseline	46.6 (30.2)
Informity Programming	65.6 (94.5)

Population analysed: The number of participants analyzed includes subjects who were available at that time of analysis

Primary outcome: 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. Mean (Standard Deviation). Unit: microjoule (μJ)

Measure	Single Arm n = 8
Baseline	46.6 (30.2)
Informity Programming	31.4 (23.9)

Population analysed: The number of participants analyzed includes subjects who were available at that time of analysis

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm	2 of 8 (25%)	1 of 8 (12.5%)	0 of 8

Limitations and caveats (from the sponsor): Subjects enrolled at the experienced centers in this study already had individually tailored therapy at the baseline visit.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Essential Tremor

Active, not recruitingObservational study
Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bradley White study chair

Abbott

Binith Cheeran study director

Abbott Medical Devices Neuromodulation

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Clinician programmer electrode screening mode tool in people with Essential Tremor and Parkinson's Disease, run by Abbott Medical Devices at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline (time frame: At Day 21 compared to baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03794661.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.