Clinical trial NCT05269862: Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
Official title: Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: ABT-CIP-10413
Virtual Clinic
Infinity DBS system
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the ROAM-DBS study is to compare the time needed to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the ADROIT initial programming visit in subjects who receive programming updates via in-clinic sessions and subjects who additionally have the option of receiving programming updates via Virtual Clinic sessions. The study intends to demonstrate shorter times to achieve benefit in the Virtual Clinic cohort.

Detailed description: The ROAM-DBS study is a prospective, multi-center, randomized control, open-label, post-market cohort study intended to gather clinical data on the effect of the NeuroSphere Virtual Clinic feature (remote care) on the time needed to optimize DBS stimulation parameters after implant. The study will enroll up to 100 subjects from up to 15 centers in geographies where Abbott DBS systems with the Virtual Clinic feature are approved, which may include North America, and Europe. Subjects should be participants in the ADROIT study (NCT04071847). Subjects will be followed to a 3 month visit where the primary endpoint will be assessed. Subjects will be further followed for 1 year for final data assessment. Subjects will remain enrolled in ADROIT after the end of the ROAM study, and will complete the ADROIT 6 month and 1 year visits under that protocol. The study is expected to enroll subjects for up to 2 years, and complete all follow-up visits within 3 years.

Eligibility criteria: Inclusion Criteria:

1. Subject is a participant in the ADROIT study.
2. Subject is over 21 years old.
3. Subject is able to read and write.
4. Subject is indicated for implant with an Infinity IPG for Parkinson's disease.
5. Subject has not previously been implanted with a DBS system.
6. The treating physician believes Virtual Clinic is appropriate as a component in the treatment regime for this subject.
7. Subject will have access to the Abbott Virtual Clinic system through a participating site.
8. Subject will have internet access on their Patient Controller in a location suitable for a Virtual Clinic session.
9. Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.

Exclusion Criteria:

1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
2. Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
3. As assessed by the treating physician, lead misplacement would prevent the DBS therapy from providing clinically meaningful benefit.
4. Subject is unable to use the Virtual Clinic feature.
5. Subject will not be able, in the investigator's opinion, to demonstrate or articulate symptoms during a Virtual Clinic visit.

Primary outcomes:
measure: Primary Efficacy Endpoint: The time to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the initial programming visit
timeFrame: PGIC will be collected within 2 days (48 hours) after completion of each programming visit
measure: Primary Safety Endpoint: Rate of programming related adverse events for the Virtual Clinic cohort
timeFrame: At 3-months after initial programming visit
Secondary outcomes:
measure: Patient Global Impression (PGI)
timeFrame: At 3-months after initial programming visit
measure: Patient Global Impression (PGI)
timeFrame: At 1 Year after initial programming visit
measure: Clinical Global Impression (CGI)
timeFrame: At 3-months after initial programming visit
measure: Clinical Global Impression (CGI)
timeFrame: At 1 Year after initial programming visit
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: At 3-months after initial programming visit
measure: Parkinson's Disease Questionnaire (PDQ-39)
timeFrame: At 1 Year after initial programming visit
measure: Levodopa Equivalent Dose (LED)
timeFrame: At 3-months after initial programming visit
measure: Levodopa Equivalent Dose (LED)
timeFrame: At 1 Year after initial programming visit
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
timeFrame: At 1 Year after initial programming visit
measure: Home Monitoring (Tremor)
timeFrame: At 3-months after initial programming visit
measure: Home Monitoring (Dyskinesia)
timeFrame: At 3-months after initial programming visit
measure: "On Time" (time each day without troublesome symptoms or side effects) (derived from Home Monitoring)
timeFrame: At 3-months after initial programming visit
measure: Health care resource utilization: Number of hospitalizations and ER visits
timeFrame: At 1 Year after initial programming visit
measure: Time to resolve programming related adverse events
timeFrame: At 1 Year after initial programming visit
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Health Sciences Center
state: Arizona
city: Sacramento
country: United States
facility: University of California at Davis
state: California
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State Medical
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson Department of Neurosurgery
state: Pennsylvania
city: Georgetown
country: United States
facility: Texas Movement Disorder Specialist
state: Texas
city: Tübingen
country: Germany
facility: Universitäts Klinikum Tübingen
state: Bad-wur
city: Düsseldorf
country: Germany
facility: Medizinische Einrichtungen der Universität Düsseldorf
state: N. Rhin
city: Mainz
country: Germany
facility: UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
state: Rhinela
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias I Pujol
city: Madrid
country: Spain
facility: Hospital Universitario de la Princesa
city: Sevilla
country: Spain
facility: Hospital Virgen de Rocio
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
state: Wdbtshr
Study officials:
affiliation: Abbott
name: Bradley White
role: STUDY_CHAIR
affiliation: Abbott Medical Devices Neuromodulation
name: Devyani Nanduri
role: STUDY_DIRECTOR
References: