Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation (ROAM-DBS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature; Device: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bad-wur
    • Tübingen, Bad-wur, Germany, 72076
      • Universitäts Klinikum Tübingen
  • N. Rhin
    • Düsseldorf, N. Rhin, Germany, 40225
      • Medizinische Einrichtungen der Universität Düsseldorf
  • Rhinela
    • Mainz, Rhinela, Germany, 55131
      • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
• Spain
  • Badalona, Spain, 08916
    • Hospital Universitari Germans Trias i Pujol
  • Madrid, Spain, 28006
    • Hospital Universitario De La Princesa
  • Sevilla, Spain, 41013
    • Hospital Virgen de Rocio
• United Kingdom
  • Wdbtshr
    • Glasgow, Wdbtshr, United Kingdom, G51 4TF
      • Queen Elizabeth University Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States, 85274
      • University of Arizona Health Sciences Center
  • California
    • Sacramento, California, United States, 95817
      • University of California at Davis
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth Hitchcock Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State Medical
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson Department of Neurosurgery
  • Texas
    • Georgetown, Texas, United States, 78628
      • Texas Movement Disorder Specialist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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).
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Global Impression (PGI)	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 an improvement or decline 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 clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.	At 3-months after initial programming visit
Patient Global Impression (PGI)	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 an improvement or decline 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 clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.	At 1 Year after initial programming visit
Clinical Global Impression (CGI)	The CGI questionnaire is widely used for assessing symptoms and consists of two subscales, one rating severity of illness (CGIS) and one rating global improvement (CGIC) (12-14). Severity is rated from 1 = normal/not at all ill to 7 = among the most extremely ill. Global improvement is rated from 1 = very much improved to 7 = very much worse. The clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.	At 3-months after initial programming visit
Clinical Global Impression (CGI)	The CGI questionnaire is widely used for assessing symptoms and consists of two subscales, one rating severity of illness (CGIS) and one rating global improvement (CGIC) (12-14). Severity is rated from 1 = normal/not at all ill to 7 = among the most extremely ill. Global improvement is rated from 1 = very much improved to 7 = very much worse. The clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.	At 1 Year after initial programming visit
Parkinson's Disease Questionnaire (PDQ-39)	PDQ-39 questionnaire is a widely used validated questionnaire to measure PD-specific health status (16-17). The self-administered questionnaire consists of 39 questions and assesses how often the subject has experienced difficulties during the past month due to PD across 8 dimensions including mobility, activities of daily living, emotional well-being, social support, cognition, communication and bodily discomfort. Each question is rated on a 5-point ordinal scoring system ranging from 0=never to 4=always. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). The overall score is expressed by a Summary Index. Lower scores reflect better quality of life. The clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.	At 3-months after initial programming visit
Parkinson's Disease Questionnaire (PDQ-39)	PDQ-39 questionnaire is a widely used validated questionnaire to measure PD-specific health status (16-17). The self-administered questionnaire consists of 39 questions and assesses how often the subject has experienced difficulties during the past month due to PD across 8 dimensions including mobility, activities of daily living, emotional well-being, social support, cognition, communication and bodily discomfort. Each question is rated on a 5-point ordinal scoring system ranging from 0=never to 4=always. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). The overall score is expressed by a Summary Index. Lower scores reflect better quality of life. The clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.	At 1 Year after initial programming visit
Levodopa Equivalent Dose (LED)	LED will be assessed and the values of virtual Clinic cohort will be compared to that of in-clinic cohort.	At 3-months after initial programming visit
Levodopa Equivalent Dose (LED)	LED will be assessed and the values of virtual Clinic cohort will be compared to that of in-clinic cohort.	At 1 Year after initial programming visit
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)	MDS-UPDRS questionnaire is a widely used validated questionnaire to assess the severity of Parkinson's disease. This questionnaire is composed of four sections, however, this study shall only utilize part III: motor examinations consisting of 33 scores based on 18 questions with several right, left or other body distribution scores. Each item is scored from 0 to 4, where 0 indicates normal, 1 indicates slight symptoms, 2 indicates mild symptoms, 3 indicates moderate symptoms, and 4 indicates severe symptoms. The total score is obtained from the sum of the corresponding item scores. Higher scores indicate greater impact of PD symptoms. The clinical scores of virtual Clinic cohort will be compared to the in-clinic cohort.	At 1 Year after initial programming visit
Home Monitoring (Tremor)	Subjects will be provided with a home monitoring kit consisting of a smart watch and smart phone and will be instructed on how to use and charge the devices in order to monitor the prevalence and severity of tremor during activities of daily living. The supplied smart phone will also provide a diary function that subjects will use to maintain notes on symptoms and medications. The smart watch data provides time stamped data indicating the presence of tremor, and its severity (slight (< 0.1 cm), mild (0.1-0.6 cm), moderate (0.6-2.2 cm),strong (>2.2 cm) and absent during each one-minute interval). The Home Monitoring equipment is validated against physician assessments of tremor. Home Monitoring data is uploaded and stored in a secured cloud server.	At 3-months after initial programming visit
Home Monitoring (Dyskinesia)	Subjects will be provided with a home monitoring kit consisting of a smart watch and smart phone and will be instructed on how to use and charge the devices in order to monitor the prevalence and severity of dyskinesia during activities of daily living. The supplied smart phone will also provide a diary function that subjects will use to maintain notes on symptoms and medications. The smart watch data provides the % of time in each 15 minute interval the subject experiences dyskinesia. The Home Monitoring equipment is validated against physician assessments of dyskinesia. Home Monitoring data is uploaded and stored in a secured cloud server.	At 3-months after initial programming visit
"On Time" (time each day without troublesome symptoms or side effects) (derived from Home Monitoring)	"On Time" (time each day without troublesome symptoms or side effects) will be assessed by summing the daily intervals where Home Monitoring data does not measure tremor or dyskinesia	At 3-months after initial programming visit
Health care resource utilization: Number of hospitalizations and ER visits	The number of hospitalizations and ER visits will be assessed	At 1 Year after initial programming visit
Time to resolve programming related adverse events	Time to resolve programming related adverse events will be assessed	At 1 Year after initial programming visit

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Study Chair: Bradley White, Abbott; Study Director: Devyani Nanduri, Abbott Medical Devices Neuromodulation

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 8, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 20, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: ABT-CIP-10413; Virtual Clinic; Infinity DBS system
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: ABT-CIP-10413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes