Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

NCT05269862 | Active Not Recruiting FDA Device

• 1 other identifier: ABT-CIP-10413
• Study Type: interventional
• Target: 100
• Locations: 4 countries
• Sites: 18

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.

Conditions

Parkinson Disease

Keywords

ABT-CIP-10413; Virtual Clinic; Infinity DBS system

Outcome Measures

Primary Outcomes (2)

• 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

  The PGI consists of 2 subscales, the first rating the severity of illness (PGIS) and the second evaluating the change in illness relative to a previous status (PGIC). The PGI scale evaluates all aspects of health and assesses if there has been a change in clinical status. The scale consists of two items, one scale rating severity of illness and one rating global improvement. Severity is rated from 1=normal/not at all ill to 7= extremely ill. Global improvement is rated from 1=very much improved to 7=very much worse. The questionnaire takes approximately 5 minutes to complete. 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 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, will be compared.

  PGIC will be collected within 2 days (48 hours) after completion of each programming visit

• Primary Safety Endpoint: Rate of programming related adverse events for the Virtual Clinic cohort

  The rate of programming related adverse events reported up to the Short Term (3 month) follow-up visit for the Virtual Clinic cohort will be summarized using counts and percentages.

  At 3-months after initial programming visit

Secondary Outcomes (14)

• Patient Global Impression (PGI)

  At 3-months after initial programming visit

• Patient Global Impression (PGI)

  At 1 Year after initial programming visit

• Clinical Global Impression (CGI)

  At 3-months after initial programming visit

• Clinical Global Impression (CGI)

  At 1 Year after initial programming visit

• Parkinson's Disease Questionnaire (PDQ-39)

  At 3-months after initial programming visit

Study Arms (2)

In-Clinic Cohort

EXPERIMENTAL

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.

Device: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature

Virtual Clinic Cohort

ACTIVE COMPARATOR

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.

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

Interventions

Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature 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).

In-Clinic Cohort

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

Virtual Clinic Cohort

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
• 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.
• As assessed by the treating physician, lead misplacement would prevent the DBS therapy from providing clinically meaningful benefit.
• Subject is unable to use the Virtual Clinic feature.
• Subject will not be able, in the investigator's opinion, to demonstrate or articulate symptoms during a Virtual Clinic visit.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (18)

University of Arizona Health Sciences Center

Tucson, Arizona, 85274, United States

Location

University of California at Davis

Sacramento, California, 95817, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State Medical

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson Department of Neurosurgery

Philadelphia, Pennsylvania, 19107, United States

Location

Texas Movement Disorder Specialist

Georgetown, Texas, 78628, United States

Location

Universitäts Klinikum Tübingen

Tübingen, Bad-wur, 72076, Germany

Location

Medizinische Einrichtungen der Universität Düsseldorf

Düsseldorf, N. RHIN, 40225, Germany

Location

UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz

Mainz, Rhinela, 55131, Germany

Location

Hospital Universitari Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Virgen de Rocio

Seville, 41013, Spain

Location

Queen Elizabeth University Hospital

Glasgow, Wdbtshr, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Bradley White

  Abbott

  STUDY CHAIR

• Devyani Nanduri

  Abbott Medical Devices Neuromodulation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: March 8, 2022
• Study Start: March 24, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (11); DE (3); ES (3); GB (1)