Coordinated Reset Deep Brain Stimulation for Parkinson's Disease (CR DBS PD)

Deep brain stimulation (DBS) is a surgical implant procedure for the treatment of Parkinson's Disease (PD) utilizing medical devices approved by the FDA. A novel approach to current DBS approaches is called "Coordinated Reset" DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS (T-DBS) that uses continuous high amplitude and high frequency stimulation. This study will evaluate the safety and short-term efficacy of CR-DBS in PD. The results from this study will significantly advance the development of CR-DBS for the treatment of PD. Findings in this study will also provide the rationale for further development of this novel DBS approach for other neurological and psychiatric disorders.

Study Overview

• Status: Not yet recruiting
• Conditions: Deep Brain Stimulation; Parkinson's Disease (PD)
• Intervention / Treatment: Device: DBS

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Marina Bryants, CCRP, BS; Phone Number: 612-624-3035; Email: bryan371@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of Idiopathic Parkinson's Disease
• Minimum age of 21 years old
• Will be or has been implanted with the Boston Scientific Vercise Genus Rechargeable DBS system

Exclusion Criteria:

• History of musculoskeletal disorders that affect movement of the limbs/gait
• Other significant neurological disorder
• Significant psychiatric disorder
• History of dementia or cognitive impairment that precludes them from getting DBS surgery or per study staff judgment, MacCAT-CR assessment does not deduce that the participant has capacity to consent
• Other significant medical disorder that could impede study participation
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CR-DBS; Randomized to either T-DBS occurring first or CR-DBS occurring first (50/50 chance of being assigned to either, but will be assessing both)	Device: DBS; Deep Brain Stimulation
Active Comparator: T-DBS; Randomized to either T-DBS occurring first or CR-DBS occurring first (50/50 chance of being assigned to either, but will be assessing both)	Device: DBS; Deep Brain Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Jing Wang, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): July 1, 2031

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson's Disease; Deep Brain Simulation
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: NEUR-2025-34279

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes