Coordinated Reset Deep Brain Stimulation for Parkinson's Disease

The MDS-UPDRS is a standard rating scale for PD that has been widely used in clinical settings and PD research. It utilizes a 4-subscale structure and 5-point (Normal = 0 to Severe = 4) severity scale. Part III of the Scale assesses the motor signs of PD through 18 items, with a maximum possible score of 72.

The KinetiGraph PKG system consists of a small watch-device worn on the wrist for collecting data over a period of several days and provides a report that shows how motor symptoms and complications of PD such as bradykinesia, tremor and dyskinesias vary throughout the day. The watch will be worn on the patient's most affected side (indicated by each patient's MDS-UPDRS III scores for two body sides).

This task assesses hypokinesia and the sequence effect (deterioration of movement amplitude over time). Pronation-supination movements will be performed using a forearm manipulandum. Movement will be visually guided and acoustically paced. Four 60-second trials will be completed each side (right and left arms), with each trial including 4 transitions in movement rate (1.0 or 1.75 Hz). Delsys inertial measurement units (IMUs) will also be used during this task to measure EMG and kinematic data.

Forearm rigidity will be assessed using a custom-built robotic manipulandum which provides reliable and objective measures of resistance to imposed motion. The device passively imposes sinusoidal movements of the forearm about the pronation-supination axis through a ± 40° range of motion at 1.5 Hz while measuring the angular displacement and resistive torque required to move the limb. Trials will be collected separately for the right and left arms, with or without an activation maneuver (tapping the contralateral hand on the leg), a technique that is used clinically to elicit or enhance rigidity. Delsys inertial measurement units (IMUs) will be used to measure the EMG activities of biceps brachii and pronator teres muscles, as secondary measurements during the task.

Trail Making Task-B will evaluate visual scanning, sequencing, cognitive flexibility and processing speed will be completed.

DKEFS Verbal Fluency Task will evaluate verbal fluency.

Quantitative assessment of accuracy and reaction time as a function of working memory load.

RDRS will assess the severity of overall dyskinesias during activities of daily living. A severity rating score of 4 indicates violent dyskinesia and 0 indicates an absence of dyskinesia. This scale can also distinguish chorea from dystonia (the two major types of dyskinesias in PD) and identify the single most disabling form of dyskinesia.

Frequency [between and within] participants with treatment-related adverse events as assessed by CTCAE v6.0. This is a qualitative collection of information via participant report or clinical observation, but will be input as quantitative (e.g., a headache can be classified as "1-Mild, 2-Moderate, and 3-Severe).

In this gait task, spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest (repeated 5x)

In this gait task, spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest (repeated 5x)

In this gait task, spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest (repeated 5x)

In this gait task, spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest (repeated 5x)

In this gait task, spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest (repeated 5x)

In this gait task, spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest (repeated 5x)

In this gait task, spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest (repeated 5x)

In this gait task, spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest (repeated 5x)

The dual-task effect on gait will be assessed by repeating the gait task; spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest while the patient performs a 1-back cognitive task.

The dual-task effect on gait will be assessed by repeating the gait task; spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest while the patient performs a 1-back cognitive task.

The dual-task effect on gait will be assessed by repeating the gait task; spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest while the patient performs a 1-back cognitive task.

The dual-task effect on gait will be assessed by repeating the gait task; spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest while the patient performs a 1-back cognitive task.

The dual-task effect on gait will be assessed by repeating the gait task; spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest while the patient performs a 1-back cognitive task.

The dual-task effect on gait will be assessed by repeating the gait task; spatial and temporal gait metrics will be obtained using wearable inertial measurement units (IMUs) on the feet, wrists, lumbar, and sternum. Patients will walk for ~1 minute, back and forth along a ~12m walkway, followed by ~1 minute of rest while the patient performs a 1-back cognitive task.