Parkinson DiseaseROAM-DBSNCT05269862
Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
A study testing Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature and Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions) in people with Parkinson Disease, run by Abbott Medical Devices at 18 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature and Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 18 sitesin 4 countries
- Study dates
- 24 Mar 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
United States11 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Rush University Medical Center
Chicago, Illinois, 60612
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Ohio State Medical
Columbus, Ohio, 43210
Texas Movement Disorder Specialist
Georgetown, Texas, 78628
Indiana University
Indianapolis, Indiana, 46202
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Miami Hospital
Miami, Florida, 33136
Thomas Jefferson Department of Neurosurgery
Philadelphia, Pennsylvania, 19107
University of California at Davis
Sacramento, California, 95817
University of Arizona Health Sciences Center
Tucson, Arizona, 85274
Germany3 sites
Medizinische Einrichtungen der Universität Düsseldorf
Düsseldorf, N. RHIN, 40225
UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz
Mainz, Rhinela, 55131
Universitäts Klinikum Tübingen
Tübingen, Bad-wur, 72076
Spain3 sites
Hospital Universitari Germans Trias I Pujol
Badalona, 08916
Hospital Universitario de la Princesa
Madrid, 28006
Hospital Virgen de Rocio
Seville, 41013
United Kingdom1 site
Queen Elizabeth University Hospital
Glasgow, Wdbtshr, G51 4TF
About this study
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.
Read the 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
- Being tested
- 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)
- Keywords
- ABT-CIP-10413, Virtual Clinic, Infinity DBS system
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic featureDevice
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At 3-months after initial programming visit
Secondary outcomes (14)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: At 1 Year after initial programming visit
Time to resolve programming related adverse events
Time to resolve programming related adverse events will be assessed
Measured: At 1 Year after initial programming visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start24 Mar 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley White, Study chair, AbbottDevyani Nanduri, Study director, Abbott Medical Devices Neuromodulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05269862
- Sponsor's protocol ID
- ABT-CIP-10413
- Acronym
- ROAM-DBS
- Status last verified
- Jul 2023
- First submitted
- 17 Jan 2022
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT05269862
- Acronym / sponsor ID
- ROAM-DBS / ABT-CIP-10413
- Conditions
- Parkinson Disease
- Keywords
- ABT-CIP-10413, Virtual Clinic, Infinity DBS system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-Clinic Cohort | Experimental | Device: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic featureSubjects who are implanted with Abbott Infinity DBS systems with the Neuosphere Virtual Clinic feature, and receive programming for their DBS system in-clinic only. |
| Virtual Clinic Cohort | Active comparator | Device: Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic featureImplant 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). | Device | In-Clinic Cohort |
| 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. | Device | Virtual Clinic Cohort |
Primary outcome
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
Time frame: PGIC will be collected within 2 days (48 hours) after completion of each 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
Time frame: At 3-months after initial programming visit
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.
14 secondary outcomes
Patient Global Impression (PGI)
Time frame: At 3-months after initial programming visit
Patient Global Impression (PGI)
Time frame: At 1 Year after initial programming visit
Clinical Global Impression (CGI)
Time frame: At 3-months after initial programming visit
Clinical Global Impression (CGI)
Time frame: At 1 Year after initial programming visit
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: At 3-months after initial programming visit
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: At 1 Year after initial programming visit
Levodopa Equivalent Dose (LED)
Time frame: At 3-months after initial programming visit
Levodopa Equivalent Dose (LED)
Time frame: At 1 Year after initial programming visit
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: At 1 Year after initial programming visit
Home Monitoring (Tremor)
Time frame: At 3-months after initial programming visit
Home Monitoring (Dyskinesia)
Time frame: At 3-months after initial programming visit
"On Time" (time each day without troublesome symptoms or side effects) (derived from Home Monitoring)
Time frame: At 3-months after initial programming visit
Health care resource utilization: Number of hospitalizations and ER visits
Time frame: At 1 Year after initial programming visit
Time to resolve programming related adverse events
Time frame: At 1 Year after initial programming visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradley White study chair
Abbott
Devyani Nanduri study director
Abbott Medical Devices Neuromodulation
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature and Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions) in people with Parkinson Disease, run by Abbott Medical Devices at 18 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Germany, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: PGIC will be collected within 2 days (48 hours) after completion of each programming visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.