Parkinson's Disease (PD)
Conditions
Keywords
deep brain stimulation, DBS, PD, Parkinson's disease
Brief 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. 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.
Interventions
DEVICEShame Control (Baseline)
Participant's device (Boston Scientific Vercise Genus neurostimulator) is turned off for 45 minutes.
DEVICEStandard of Care Deep Brain Stimulation
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.
DEVICEIllumina 3D Deep Brain Stimulation
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.
DEVICEIllumina 3D Deep Brain Stimulation Reduced Amplitude
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.
DEVICEIllumina 3D Deep Brain Stimulation Higher Amplitude
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.
Sponsors
Stanford University
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Dementia * Unable or unwilling to come OFF DBS for a short period of time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in QDG Mobility Score (OFF DBS to Illumina 3D) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in QDG Tremor Severity Score (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in QDG Percent Rest Tremor (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in QDG Press Amplitude (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in QDG Press Amplitude Coefficient of Variation (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in QDG Interstrike Interval (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in QDG Release Slope (OFF DBS to Illumina 3D). | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in QDG Press Speed (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in QDG Interstrike Interval Coefficient of Variation (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in QDG Percent Freezing (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in Gait Speed (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in Gait Arrhythmicity (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in MDS-UPDRS III Total Score (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in MDS-UPDRS III Bradykinesia Subscore (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in MDS-UPDRS III Rigidity Subscore (OFF DBS to Illumina 3D | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in MDS-UPDRS III Tremor Subscore (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in MDS-UPDRS III Axial Subscore (OFF DBS to Illumina 3D) | Baseline (OFF DBS) and after 45 minutes of Illumina 3D DBS | 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 |
| Change in QDG Mobility Score (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC 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. 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. |
| Change in QDG Tremor Severity Score (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in QDG Percent Rest Tremor (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in QDG Press Amplitude (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in QDG Press Amplitude Coefficient of Variation (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in QDG Interstrike Interval (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in QDG Release Slope (SoC DBS to Illumina 3D). | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in QDG Press Speed (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in QDG Interstrike Interval Coefficient of Variation (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in QDG Percent Freezing (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in Gait Speed (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in Gait Arrhythmicity (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in MDS-UPDRS III Total Score (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in MDS-UPDRS III Bradykinesia Subscore (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in MDS-UPDRS III Rigidity Subscore (SoC DBS to Illumina 3D | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in MDS-UPDRS III Tremor Subscore (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
| Change in MDS-UPDRS III Axial Subscore (SoC DBS to Illumina 3D) | After 45 minutes of Illumina 3D DBS and 45 minutes SoC DBS | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHelen Bronte-Stewart, MD, MSE
Stanford University
Outcome results
None listed