Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool

NCT03794661 | Completed Results FDA Device

• 1 other identifier: ABT-CIP-10245
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

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).

Conditions

Essential Tremor; Parkinson's Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  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

  At baseline

• Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months

  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

  At 6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Clinician programmer electrode screening mode tool

Device: Clinician programmer electrode screening mode tool

Interventions

Clinician programmer electrode screening mode tool DEVICE

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

Also known as: Informity tool

Single Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (3)

Albany Medical Center

Albany, New York, 12208, United States

Location

The University of Texas Health Science at San Antonio

San Antonio, Texas, 78229, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

MeSH Terms

Conditions

Essential Tremor; Parkinson Disease

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

Subjects enrolled at the experienced centers in this study already had individually tailored therapy at the baseline visit.

Results Point of Contact

• Title: Binith Cheeran
• Organization: Abbott Medical Devices Neuromodulation

binith.cheeran@abbott.com

+15122864262

Study Officials

• Bradley White

  Abbott

  STUDY CHAIR

• Binith Cheeran

  Abbott Medical Devices Neuromodulation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Outcomes assessor will be masked to subjects' deep brain stimulation programming.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: January 7, 2019
• Study Start: June 26, 2019
• Primary Completion: December 16, 2020
• Study Completion: December 16, 2020
• Last Updated: March 31, 2022
• Results First Posted: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)