Clinical trial NCT03794661: Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
Official title: Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Parkinson's Disease
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2019-01-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline
timeFrame: At Day 21 compared to baseline
measure: Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline
timeFrame: At Day 21 compared to baseline
measure: Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline
timeFrame: At Day 21 compared to baseline
measure: Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline
timeFrame: At Day 21 compared to baseline
Secondary outcomes:
measure: Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months
timeFrame: At 3 months compared to baseline
measure: Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months
timeFrame: At 6 months compared to baseline
measure: Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline
timeFrame: At baseline
measure: Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months
timeFrame: At 3 months
measure: Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months
timeFrame: At 6 months
measure: Mean Duration of Programming
timeFrame: At Day 21
measure: Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months
timeFrame: At 3 months compared to baseline
measure: Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months
timeFrame: At 6 months compared to baseline
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: San Antonio
country: United States
facility: The University of Texas Health Science at San Antonio
state: Texas
city: Spokane
country: United States
facility: Inland Northwest Research
state: Washington
Study officials:
affiliation: Abbott
name: Bradley White
role: STUDY_CHAIR
affiliation: Abbott Medical Devices Neuromodulation
name: Binith Cheeran
role: STUDY_DIRECTOR
References: