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

• ClinicalTrials.gov Identifier: NCT03794661
• Recruitment Status: Completed
• First Posted: January 7, 2019
• Last Update Posted: January 7, 2021
• 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 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 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 27, 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. 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

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, 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

• Study Chair: Bradley White; Abbott
• Study Chair: Florence Defresne; Abbott
• Study Director: Edward Karst; Abbott Neuromodulation

More Information

• Responsible Party: Abbott Medical Devices
• ClinicalTrials.gov Identifier: NCT03794661
• Other Study ID Numbers: ABT-CIP-10245
• First Posted: January 7, 2019
• 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

Additional relevant MeSH terms:

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