Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

NCT ID: NCT03794661

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2020-12-16

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

Conditions

Essential Tremor; Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Single Arm

Clinician programmer electrode screening mode tool

Group Type: EXPERIMENTAL

Clinician programmer electrode screening mode tool

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Informity tool

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bradley White

Role: STUDY_CHAIR

Abbott

Binith Cheeran

Role: STUDY_DIRECTOR

Abbott Medical Devices Neuromodulation

Locations

Albany Medical Center

Albany, New York, United States

The University of Texas Health Science at San Antonio

San Antonio, Texas, United States

Inland Northwest Research

Spokane, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ABT-CIP-10245

Identifier Type: -

Identifier Source: org_study_id