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

Primary Purpose

Parkinson Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring ABT-CIP-10413, Virtual Clinic, Infinity DBS system

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arizona Health Sciences Center
  • University of California at Davis
  • University of Miami Hospital
  • Rush University Medical Center
  • Indiana University
  • Beth Israel Deaconess Medical Center
  • Dartmouth Hitchcock Medical Center
  • The Cleveland Clinic Foundation
  • Ohio State Medical
  • Thomas Jefferson Department of Neurosurgery
  • Texas Movement Disorder Specialist
  • Universitäts Klinikum Tübingen
  • Medizinische Einrichtungen der Universität Düsseldorf
  • UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
  • Hospital Universitari Germans Trias I Pujol
  • Hospital Universitario de la Princesa
  • Hospital Virgen de Rocio
  • Queen Elizabeth University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

In-Clinic Cohort

Virtual Clinic Cohort

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Levodopa Equivalent Dose (LED)
LED will be assessed and the values of virtual Clinic cohort will be compared to that of in-clinic cohort.
Levodopa Equivalent Dose (LED)
LED will be assessed and the values of virtual Clinic cohort will be compared to that of in-clinic cohort.
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.
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.
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.
"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
Health care resource utilization: Number of hospitalizations and ER visits
The number of hospitalizations and ER visits will be assessed
Time to resolve programming related adverse events
Time to resolve programming related adverse events will be assessed

Full Information

First Posted
January 17, 2022
Last Updated
July 20, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT05269862
Brief Title
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
Acronym
ROAM-DBS
Official Title
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
ABT-CIP-10413, Virtual Clinic, Infinity DBS system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
In-Clinic Cohort
Arm Type
Experimental
Arm Description
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.
Arm Title
Virtual Clinic Cohort
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature
Intervention Description
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
Intervention Name(s)
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
PGIC will be collected within 2 days (48 hours) after completion of each programming visit
Title
Primary Safety Endpoint: Rate of programming related adverse events for the Virtual Clinic cohort
Description
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.
Time Frame
At 3-months after initial programming visit
Secondary Outcome Measure Information:
Title
Patient Global Impression (PGI)
Description
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.
Time Frame
At 3-months after initial programming visit
Title
Patient Global Impression (PGI)
Description
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.
Time Frame
At 1 Year after initial programming visit
Title
Clinical Global Impression (CGI)
Description
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.
Time Frame
At 3-months after initial programming visit
Title
Clinical Global Impression (CGI)
Description
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.
Time Frame
At 1 Year after initial programming visit
Title
Parkinson's Disease Questionnaire (PDQ-39)
Description
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.
Time Frame
At 3-months after initial programming visit
Title
Parkinson's Disease Questionnaire (PDQ-39)
Description
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.
Time Frame
At 1 Year after initial programming visit
Title
Levodopa Equivalent Dose (LED)
Description
LED will be assessed and the values of virtual Clinic cohort will be compared to that of in-clinic cohort.
Time Frame
At 3-months after initial programming visit
Title
Levodopa Equivalent Dose (LED)
Description
LED will be assessed and the values of virtual Clinic cohort will be compared to that of in-clinic cohort.
Time Frame
At 1 Year after initial programming visit
Title
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Description
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.
Time Frame
At 1 Year after initial programming visit
Title
Home Monitoring (Tremor)
Description
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.
Time Frame
At 3-months after initial programming visit
Title
Home Monitoring (Dyskinesia)
Description
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.
Time Frame
At 3-months after initial programming visit
Title
"On Time" (time each day without troublesome symptoms or side effects) (derived from Home Monitoring)
Description
"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
Time Frame
At 3-months after initial programming visit
Title
Health care resource utilization: Number of hospitalizations and ER visits
Description
The number of hospitalizations and ER visits will be assessed
Time Frame
At 1 Year after initial programming visit
Title
Time to resolve programming related adverse events
Description
Time to resolve programming related adverse events will be assessed
Time Frame
At 1 Year after initial programming visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley White
Organizational Affiliation
Abbott
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Devyani Nanduri
Organizational Affiliation
Abbott Medical Devices Neuromodulation
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85274
Country
United States
Facility Name
University of California at Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State Medical
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Thomas Jefferson Department of Neurosurgery
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Texas Movement Disorder Specialist
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78628
Country
United States
Facility Name
Universitäts Klinikum Tübingen
City
Tübingen
State/Province
Bad-wur
ZIP/Postal Code
72076
Country
Germany
Facility Name
Medizinische Einrichtungen der Universität Düsseldorf
City
Düsseldorf
State/Province
N. Rhin
ZIP/Postal Code
40225
Country
Germany
Facility Name
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
City
Mainz
State/Province
Rhinela
ZIP/Postal Code
55131
Country
Germany
Facility Name
Hospital Universitari Germans Trias I Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Virgen de Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
State/Province
Wdbtshr
ZIP/Postal Code
G51 4TF
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

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