Parkinson's Disease (PD)NCT07215481
Automated Image-Guided Programming of Deep Brain Stimulation (DBS) for Parkinson's Disease
A study testing Illumina 3D Deep Brain Stimulation, Illumina 3D Deep Brain Stimulation Reduced Amplitude and Illumina 3D Deep Brain Stimulation Higher Amplitude in people with Parkinson's Disease (PD), run by Stanford University at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate an automated deep brain stimulation (DBS) algorithm developed by Boston Scientific called Illumina 3D for motor symptoms in Parkinson's disease (PD). The main question it aims to answer is: Is this new automated algorithm effective for treating motor symptoms of PD. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson's Disease (PD)
- What is being tested?
- Illumina 3D Deep Brain Stimulation, Illumina 3D Deep Brain Stimulation Reduced Amplitude and Illumina 3D Deep Brain Stimulation Higher Amplitude
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2026to Dec 2027
- 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
- Diagnosis of Parkinson's disease (PD)
- Newly implanted or soon to be implanted with deep brain stimulation (Boston Scientific device)
- Willingness to withdraw from clinical medication regimen when necessary for research visits
Who cannot join
- Dementia
- Unable or unwilling to come OFF DBS for a short period of time
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford Neuroscience Health Clinic
Stanford, California, 94305
About this study
Official title: Quantitative Digitography to Evaluate the Efficacy of Image Guided Algorithmic DBS Programming
The goal of this clinical trial is to evaluate an automated deep brain stimulation (DBS) algorithm developed by Boston Scientific called Illumina 3D for motor symptoms in Parkinson's disease (PD). The main question it aims to answer is: Is this new automated algorithm effective for treating motor symptoms of PD. Fifteen participants are anticipated to be enrolled.
Participants are individuals who recently were implanted with DBS in the subthalamic nucleus as part of their regular clinical treatment and are scheduled to have their DBS turned ON for the first time. In addition to their regular clinical visit when their DBS is turned ON by their clinician, participants are tested on DBS settings determined by Illumina 3D (an automated algorithm). Participants are tested on these different settings across different motor tasks, including walking and finger tapping, as well as answering questionnaires. The experiment is expected to last 1 or 2 days; this is not a longitudinal or long-term trial. Participants return to their usual DBS settings once they leave the clinic.
- Conditions
- Parkinson's Disease (PD)
- Being tested
- Shame Control (Baseline), Standard of Care Deep Brain Stimulation, Illumina 3D Deep Brain Stimulation, Illumina 3D Deep Brain Stimulation Reduced Amplitude, Illumina 3D Deep Brain Stimulation Higher Amplitude
- Keywords
- deep brain stimulation, DBS, PD, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shame Control (Baseline)Device
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned off for 45 minutes.
Standard of Care Deep Brain StimulationDevice
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined as standard of care by the clinician.
Illumina 3D Deep Brain StimulationDevice
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm.
Illumina 3D Deep Brain Stimulation Reduced AmplitudeDevice
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm but at a reduced stimulation amplitude.
Illumina 3D Deep Brain Stimulation Higher AmplitudeDevice
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm but at a higher stimulation amplitude.
| Study group | Role | What they receive |
|---|---|---|
| Deep Brain Stimulation | Experimental | Participants start with a sham condition (baseline) for approximately 45 minutes. Participants then receive the following four deep brain stimulation conditions in a randomized order for approximately 45 minutes each delivered by the Boston Scientific Vercise Genus neurostimulator. Neither the participants nor the assessor will be aware of what condition they receive. Before starting the condition, there will be a wash in for approximately 15 minutes. Participants will then perform tasks and questionnaires for approximately 30 minutes on each condition.
The four conditions are:
1. Standard of Care Deep Brain Stimulation
2. Illumina 3D Deep Brain Stimulation
3. Illumina 3D Deep Brain Stimulation Reduced Amplitude
4. Illumina 3D Deep Brain Stimulation Higher Amplitude Receives: Device: Shame Control (Baseline); Device: Standard of Care Deep Brain Stimulation; Device: Illumina 3D Deep Brain Stimulation; Device: Illumina 3D Deep Brain Stimulation Reduced Amplitude; Device: Illumina 3D Deep Brain Stimulation Higher Amplitude |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in QDG Mobility Score (OFF DBS to Illumina 3D)
Quantitative Digitography (QDG) Mobility Score is a single score representing a participant's overall movement proficiency by combining performance across different aspects of movement including speed, frequency, amplitude, and rhythmicity measured using an engineered Keyduo QDG device during an alternating finger pressing and releasing with the index and middle finger. It is represented by a single value between 0 and 100 for each hand, where 100 represents ideal performance. The primary outcome is the difference in QDG Mobility Score from the OFF DBS condition (baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG mobility score will be used.
Measured: Baseline and after 45 minutes of Illumina 3D DBS
Secondary outcomes (33)
Change in QDG Tremor Severity Score (OFF DBS to Illumina 3D)
A single score representing the proportion and amplitude of tremor-identified strikes using an engineered Keyduo QDG device. It is represented by a single value between 0 and 100, where 100 represents the worst tremor severity. A secondary outcome is the difference in QDG Tremor Severity Score from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Percent Rest Tremor (OFF DBS to Illumina 3D)
The proportion of tremor-identified strikes using an engineered Keyduo QDG device. Range from 0 to 100%. A secondary outcome is the difference in QDG Percent Rest Trremor from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Press Amplitude (OFF DBS to Illumina 3D)
The average amplitude of strikes using an engineered Keyduo QDG device. Ranges from 0 to 14 mm. A secondary outcome is the difference in QDG Press Amplitude from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Press Amplitude Coefficient of Variation (OFF DBS to Illumina 3D)
The coefficient of variation of press amplitude of strikes using an engineered Keyduo QDG device. A secondary outcome is the difference in QDG Press Amplitude Coefficient of Variation from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Interstrike Interval (OFF DBS to Illumina 3D)
The interstrike-interval (i.e., the time it takes to complete one full press and release of the lever) of alternating tapping will be measured using an engineered Keyduo QDG device. The interstrike-interval is a time in milliseconds. A secondary outcome is the difference in QDG Interstrike Interval from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Release Slope (OFF DBS to Illumina 3D).
The average speed of release using an engineered Keyduo QDG device. Units of cm/s. A secondary outcome is the difference in QDG Release Slope from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Press Speed (OFF DBS to Illumina 3D)
The average speed of the press using an engineered Keyduo QDG device. Units of cm/s. A secondary outcome is the difference in QDG Press Speed from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Interstrike Interval Coefficient of Variation (OFF DBS to Illumina 3D)
The variability of the interstrike-interval of alternating tapping, as quantified by the coefficient of variation, will be measured using an engineered Keyduo QDG device. A secondary outcome is the difference in QDG Interstrike interval coefficient of varation from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Percent Freezing (OFF DBS to Illumina 3D)
Proportion of freezing of finger tapping using a validated algorithm. Range from 0 to 100%. A secondary outcome is the difference in QDG Percent Freezing from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in Gait Speed (OFF DBS to Illumina 3D)
The time it takes a person to walk a specified distance on level ground as measured by the GaitRite. Reported as m/s. A secondary outcome is the difference in gait speed from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in Gait Arrhythmicity (OFF DBS to Illumina 3D)
Stride (gait cycle) time will be measured using the GaitRite. Gait arrhythmicity is defined as the mean stride time coefficient of variation (CV) of both legs. A greater stride time CV is indicative of less rhythmic gait/stepping. A secondary outcome is the difference in gait arrhythmicity from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Total Score (OFF DBS to Illumina 3D)
PD symptoms will be assessed clinically using the MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Section III. This is a motor examination to evaluate speech, facial expression, tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements, rapid alternating movement of hands, leg agility, arising from chair, posture, gait, freezing of gait, posture, body bradykinesia, and postural stability. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 132. A secondary outcome is the difference in MDS-UPDRS III from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Bradykinesia Subscore (OFF DBS to Illumina 3D)
Bradykinesia-related items of the MDS-UPDRS III, which includes items 3.4-3.8. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 40. A secondary outcome is the difference in MDS-UPDRS III Bradykinesia subscore from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Rigidity Subscore (OFF DBS to Illumina 3D
Rigidity-related items of the MDS-UPDRS III, which includes item 3.3. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 20. A secondary outcome is the difference in MDS-UPDRS III Rigidity subscore from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Tremor Subscore (OFF DBS to Illumina 3D)
Tremor-related items of the MDS-UPDRS III, which includes items 3.15-3.18. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 40. A secondary outcome is the difference in MDS-UPDRS III Tremor subscore from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Axial Subscore (OFF DBS to Illumina 3D)
Axial-related items of the MDS-UPDRS III, which includes items 3.1, 3.2, and 3.9-3.14. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 32. A secondary outcome is the difference in MDS-UPDRS III Axial subscore from the OFF DBS condition (Baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Mobility Score (SoC DBS to Illumina 3D)
Quantitative Digitography (QDG) Mobility Score is a single score representing a participant's overall movement proficiency by combining performance across different aspects of movement including speed, frequency, amplitude, and rhythmicity measured using an engineered Keyduo QDG device during an alternating finger pressing and releasing with the index and middle finger. It is represented by a single value between 0 and 100 for each hand, where 100 represents ideal performance. A secondary outcome is the difference in QDG Mobility Score from the Standard of Care (SoC) DBS condition to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG mobility score will be used.
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Tremor Severity Score (SoC DBS to Illumina 3D)
A single score representing the proportion and amplitude of tremor-identified strikes using an engineered Keyduo QDG device. It is represented by a single value between 0 and 100, where 100 represents the worst tremor severity. A secondary outcome is the difference in QDG Mobility Score from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Percent Rest Tremor (SoC DBS to Illumina 3D)
The proportion of tremor-identified strikes using an engineered Keyduo QDG device. Range from 0 to 100%. A secondary outcome is the difference in QDG Mobility Score from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Press Amplitude (SoC DBS to Illumina 3D)
The average amplitude of strikes using an engineered Keyduo QDG device. Ranges from 0 to 14 mm. A secondary outcome is the difference in QDG Press Amplitude from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Press Amplitude Coefficient of Variation (SoC DBS to Illumina 3D)
The coefficient of variation of press amplitude of strikes using an engineered Keyduo QDG device. A secondary outcome is the difference in QDG Press Amplitude Coefficient of Variation from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Interstrike Interval (SoC DBS to Illumina 3D)
The interstrike-interval (i.e., the time it takes to complete one full press and release of the lever) of alternating tapping will be measured using an engineered Keyduo QDG device. The interstrike-interval is a time in milliseconds. A secondary outcome is the difference in QDG Interstrike Interval from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Release Slope (SoC DBS to Illumina 3D).
The average speed of release using an engineered Keyduo QDG device. Units of cm/s. A secondary outcome is the difference in QDG Release Slope from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Press Speed (SoC DBS to Illumina 3D)
The average speed of the press using an engineered Keyduo QDG device. Units of cm/s. A secondary outcome is the difference in QDG Press Speed from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Interstrike Interval Coefficient of Variation (SoC DBS to Illumina 3D)
The variability of the interstrike-interval of alternating tapping, as quantified by the coefficient of variation, will be measured using an engineered Keyduo QDG device. A secondary outcome is the difference in QDG Interstrike Interval Coefficient of Variation from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Percent Freezing (SoC DBS to Illumina 3D)
Proportion of freezing of finger tapping using a validated algorithm. Range from 0 to 100%. A secondary outcome is the difference in QDG Percent Freezingfrom the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in Gait Speed (SoC DBS to Illumina 3D)
The time it takes a person to walk a specified distance on level ground as measured by the GaitRite. Reported as m/s. A secondary outcome is the difference in Gait Speed from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in Gait Arrhythmicity (SoC DBS to Illumina 3D)
Stride (gait cycle) time will be measured using the GaitRite. Gait arrhythmicity is defined as the mean stride time coefficient of variation (CV) of both legs. A greater stride time CV is indicative of less rhythmic gait/stepping. A secondary outcome is the difference in Gait Arrhythmicity from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Total Score (SoC DBS to Illumina 3D)
PD symptoms will be assessed clinically using the MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Section III. This is a motor examination to evaluate speech, facial expression, tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements, rapid alternating movement of hands, leg agility, arising from chair, posture, gait, freezing of gait, posture, body bradykinesia, and postural stability. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 132. A secondary outcome is the difference in MDS-UPDRS III from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Bradykinesia Subscore (SoC DBS to Illumina 3D)
Bradykinesia-related items of the MDS-UPDRS III. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 40.
A secondary outcome is the difference in MDS-UPDRS III Bradykinesia subscore from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Rigidity Subscore (SoC DBS to Illumina 3D
Rigidity-related items of the MDS-UPDRS III. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 20. A secondary outcome is the difference in MDS-UPDRS III Rigidity subscrore from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Tremor Subscore (SoC DBS to Illumina 3D)
Tremor-related items of the MDS-UPDRS III. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 40. A secondary outcome is the difference in MDS-UPDRS III Tremor subscore from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Axial Subscore (SoC DBS to Illumina 3D)
Axial-related items of the MDS-UPDRS III. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 32. A secondary outcome is the difference in MDS-UPDRS III Axial subscore from the Standard of Care (SoC) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG Mobility Score will be used
Measured: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Helen M. Bronte-Stewart, Stanford University
- Investigators
- Helen Bronte-Stewart, MD, MSE, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215481
- Sponsor's protocol ID
- 83174
- Status last verified
- Apr 2026
- First submitted
- 9 Oct 2025
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Digitography to Evaluate the Efficacy of Image Guided Algorithmic DBS Programming
- ClinicalTrials.gov ID
- NCT07215481
- Acronym / sponsor ID
- 83174
- Conditions
- Parkinson's Disease (PD)
- Keywords
- deep brain stimulation, DBS, PD, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Oct 2025 (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 goal of this clinical trial is to evaluate an automated deep brain stimulation (DBS) algorithm developed by Boston Scientific called Illumina 3D for motor symptoms in Parkinson's disease (PD). The main question it aims to answer is: Is this new automated algorithm effective for treating motor symptoms of PD. Fifteen participants are anticipated to be enrolled.
Participants are individuals who recently were implanted with DBS in the subthalamic nucleus as part of their regular clinical treatment and are scheduled to have their DBS turned ON for the first time. In addition to their regular clinical visit when their DBS is turned ON by their clinician, participants are tested on DBS settings determined by Illumina 3D (an automated algorithm). Participants are tested on these different settings across different motor tasks, including walking and finger tapping, as well as answering questionnaires. The experiment is expected to last 1 or 2 days; this is not a longitudinal or long-term trial. Participants return to their usual DBS settings once they leave the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deep Brain Stimulation | Experimental | Device: Shame Control (Baseline), Device: Standard of Care Deep Brain Stimulation, Device: Illumina 3D Deep Brain Stimulation, Device: Illumina 3D Deep Brain Stimulation Reduced Amplitude, Device: Illumina 3D Deep Brain Stimulation Higher AmplitudeParticipants start with a sham condition (baseline) for approximately 45 minutes. Participants then receive the following four deep brain stimulation conditions in a randomized order for approximately 45 minutes each delivered by the Boston Scientific Vercise Genus neurostimulator. Neither the participants nor the assessor will be aware of what condition they receive. Before starting the condition, there will be a wash in for approximately 15 minutes. Participants will then perform tasks and questionnaires for approximately 30 minutes on each condition. The four conditions are: 1. Standard of Care Deep Brain Stimulation 2. Illumina 3D Deep Brain Stimulation 3. Illumina 3D Deep Brain Stimulation Reduced Amplitude 4. Illumina 3D Deep Brain Stimulation Higher Amplitude |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Parkinson's disease (PD)
- Newly implanted or soon to be implanted with deep brain stimulation (Boston Scientific device)
- Willingness to withdraw from clinical medication regimen when necessary for research visits
Key exclusion criteria (2 listed)
- Dementia
- Unable or unwilling to come OFF DBS for a short period of time
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 |
|---|---|---|
| Shame Control (Baseline)Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned off for 45 minutes. | Device | Deep Brain Stimulation |
| Standard of Care Deep Brain StimulationParticipant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined as standard of care by the clinician. | Device | Deep Brain Stimulation |
| Illumina 3D Deep Brain StimulationParticipant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm. | Device | Deep Brain Stimulation |
| Illumina 3D Deep Brain Stimulation Reduced AmplitudeParticipant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm but at a reduced stimulation amplitude. | Device | Deep Brain Stimulation |
| Illumina 3D Deep Brain Stimulation Higher AmplitudeParticipant's device (Boston Scientific Vercise Genus neurostimulator) is turned 'ON' for 45 minutes using a configuration and amplitude determined by the automated Illumina 3D algorithm but at a higher stimulation amplitude. | Device | Deep Brain Stimulation |
Primary outcome
Change in QDG Mobility Score (OFF DBS to Illumina 3D)
Time frame: Baseline and after 45 minutes of Illumina 3D DBS
Quantitative Digitography (QDG) Mobility Score is a single score representing a participant's overall movement proficiency by combining performance across different aspects of movement including speed, frequency, amplitude, and rhythmicity measured using an engineered Keyduo QDG device during an alternating finger pressing and releasing with the index and middle finger. It is represented by a single value between 0 and 100 for each hand, where 100 represents ideal performance. The primary outcome is the difference in QDG Mobility Score from the OFF DBS condition (baseline) to Illumina 3D DBS. The Illumina 3D DBS amplitude condition with the highest QDG mobility score will be used.
33 secondary outcomes
Change in QDG Tremor Severity Score (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Percent Rest Tremor (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Press Amplitude (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Press Amplitude Coefficient of Variation (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Interstrike Interval (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Release Slope (OFF DBS to Illumina 3D).
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Press Speed (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Interstrike Interval Coefficient of Variation (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Percent Freezing (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in Gait Speed (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in Gait Arrhythmicity (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Total Score (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Bradykinesia Subscore (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Rigidity Subscore (OFF DBS to Illumina 3D
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Tremor Subscore (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in MDS-UPDRS III Axial Subscore (OFF DBS to Illumina 3D)
Time frame: Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS
Change in QDG Mobility Score (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Tremor Severity Score (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Percent Rest Tremor (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Press Amplitude (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Press Amplitude Coefficient of Variation (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Interstrike Interval (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Release Slope (SoC DBS to Illumina 3D).
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Press Speed (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Interstrike Interval Coefficient of Variation (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in QDG Percent Freezing (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in Gait Speed (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in Gait Arrhythmicity (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Total Score (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Bradykinesia Subscore (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Rigidity Subscore (SoC DBS to Illumina 3D
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Tremor Subscore (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
Change in MDS-UPDRS III Axial Subscore (SoC DBS to Illumina 3D)
Time frame: After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS
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 27 Apr 2026.
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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.
Helen Bronte-Stewart, MD, MSE principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Illumina 3D Deep Brain Stimulation, Illumina 3D Deep Brain Stimulation Reduced Amplitude and Illumina 3D Deep Brain Stimulation Higher Amplitude in people with Parkinson's Disease (PD), run by Stanford University at 1 site in United States.
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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Change in QDG Mobility Score (OFF DBS to Illumina 3D) (time frame: Baseline and after 45 minutes of Illumina 3D DBS). 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 27 Apr 2026.