Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

NCT ID: NCT05269862

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-24
• Study Completion Date: 2024-12-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

In-Clinic Cohort

Subjects who are implanted with Abbott Infinity DBS systems with the Neuosphere Virtual Clinic feature, and receive programming for their DBS system in-clinic only.

Group Type: EXPERIMENTAL

Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature

Intervention Type: DEVICE

Implant and initial programming of the Infinity DBS system for this cohort are conducted according to the sites standard of care. After initial programming, all follow-up programming for the first 3 months is conducted in-clinic (not using the Virtual Clinic feature).

Virtual Clinic Cohort

Subjects who are implanted with Abbott Infinity DBS systems with the Neuosphere Virtual Clinic feature, and receive programming for their DBS system with Virtual Clinic and in-clinic sessions.

Group Type: ACTIVE_COMPARATOR

Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)

Intervention Type: DEVICE

Implant and initial programming of the Infinity DBS system for this cohort are conducted according to the sites standard of care. After initial programming, all follow-up programming for the first 3 months is conducted using Virtual Clinic or in-clinic as appropriate.

Interventions

Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature

Implant and initial programming of the Infinity DBS system for this cohort are conducted according to the sites standard of care. After initial programming, all follow-up programming for the first 3 months is conducted in-clinic (not using the Virtual Clinic feature).

Intervention Type: DEVICE

Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)

Implant and initial programming of the Infinity DBS system for this cohort are conducted according to the sites standard of care. After initial programming, all follow-up programming for the first 3 months is conducted using Virtual Clinic or in-clinic as appropriate.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 21 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

Devyani Nanduri

Role: STUDY_DIRECTOR

Abbott Medical Devices Neuromodulation

Locations

University of Arizona Health Sciences Center

Tucson, Arizona, United States

University of California at Davis

Sacramento, California, United States

University of Miami Hospital

Miami, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Ohio State Medical

Columbus, Ohio, United States

Thomas Jefferson Department of Neurosurgery

Philadelphia, Pennsylvania, United States

Texas Movement Disorder Specialist

Georgetown, Texas, United States

Universitäts Klinikum Tübingen

Tübingen, Bad-wur, Germany

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, N. RHIN, Germany

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, Germany

Hospital Universitari Germans Trias I Pujol

Badalona, , Spain

Hospital Universitario de la Princesa

Madrid, , Spain

Hospital Virgen de Rocio

Seville, , Spain

Queen Elizabeth University Hospital

Glasgow, Wdbtshr, United Kingdom

Countries

United States; Germany; Spain; United Kingdom

Other Identifiers

ABT-CIP-10413

Identifier Type: -

Identifier Source: org_study_id