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

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ClinicalTrials.gov Identifier: NCT03794661
Recruitment Status : Completed
First Posted : January 7, 2019
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

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 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

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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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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



Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Abbott Medical Devices
Investigators
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Study Chair: Bradley White Abbott
Study Chair: Florence Defresne Abbott
Study Director: Edward Karst Abbott Neuromodulation
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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

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