Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool (EVIDENT)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03794661 |
Recruitment Status :
Completed
First Posted : January 7, 2019
Last Update Posted : January 7, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 27, 2019 |
Actual Primary Completion Date : | December 16, 2020 |
Actual Study Completion Date : | December 16, 2020 |

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 |
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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 |
Responsible Party: | Abbott Medical Devices |
ClinicalTrials.gov Identifier: | NCT03794661 |
Other Study ID Numbers: |
ABT-CIP-10245 |
First Posted: | January 7, 2019 Key Record Dates |
Last Update Posted: | January 7, 2021 |
Last Verified: | September 2020 |
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 |
Parkinson Disease Essential Tremor Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |