Clinical Trial Radar

Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III

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.

Through participant study completion, an average of two months

Frequency and Severity of Bradykinesia, Dyskinesia, Tremor, Sleep Quality and Fragmentation Scores Measured via KinetiGraph.

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).

Through participant study completion, an average of two months

Amplitude Decrement via Rapid Alternating Movements (RAMs)

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.

Through participant study completion, an average of two months

Forearm Rigidity

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.

Through participant study completion, an average of two months

Cognitive Measurements (TMT-B)

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

Through participant study completion, an average of two months

Verbal Fluency Measurement (DKEFS)

DKEFS Verbal Fluency Task will evaluate verbal fluency.

Through participant study completion, an average of two months

Working Memory Assessment via N-Back Task

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

Through participant study completion, an average of two months

Dyskinesia Assessment via Rush Dyskinesia Rating Scale (RDRS)

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.

Through participant study completion, an average of two months

Frequency of participants with adverse events as assessed by CTCAE v6.0

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).

Through participant study completion, an average of two months

Step Length ("Steady-State Gait")

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)

Through participant study completion, an average of two months

Gait Speed ("Steady-State Gait")

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)

Through participant study completion, an average of two months

Cadence ("Steady-State Gait")

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)

Through participant study completion, an average of two months

Step Variability ("Steady-State Gait")

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)

Through participant study completion, an average of two months

Step Asymmetry ("Steady-State Gait")

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)

Through participant study completion, an average of two months

Swing Time Variability ("Steady-State Gait")

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)

Through participant study completion, an average of two months

Frequency of Freezing of Gait ("Steady-State Gait")

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)

Through participant study completion, an average of two months

Duration of Freezing of Gait ("Steady-State Gait")

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)

Through participant study completion, an average of two months

Difference in Step Length (w/ and w/o 1-Back; "Dual-Task Effect on Gait")

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.

Through participant study completion, an average of two months

Difference in Gait Speed (w/ and w/o 1-Back; "Dual-Task Effect on Gait")

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.

Through participant study completion, an average of two months

Difference in Cadence (w/ and w/o 1-Back; "Dual-Task Effect on Gait")

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.

Through participant study completion, an average of two months

Difference in Step Variability (w/ and w/o 1-Back; "Dual-Task Effect on Gait")

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.

Through participant study completion, an average of two months

Difference in Step Asymmetry (w/ and w/o 1-Back; "Dual-Task Effect on Gait")

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.

Through participant study completion, an average of two months

Difference in Swing Time Variability (w/ and w/o 1-Back; "Dual-Task Effect on Gait")

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.

Through participant study completion, an average of two months