Automated Image-Guided Programming of Deep Brain Stimulation (DBS) for Parkinson's Disease

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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