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

September 11, 2026 updated by: University of Minnesota
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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kaylee Lymon, PhD
  • Phone Number: 612-626-0877
  • Email: klymon@umn.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III
Time Frame: Through participant study completion, an average of two months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency and Severity of Bradykinesia, Dyskinesia, Tremor, Sleep Quality and Fragmentation Scores Measured via KinetiGraph.
Time Frame: Through participant study completion, an average of two months
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)
Time Frame: Through participant study completion, an average of two months
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
Time Frame: Through participant study completion, an average of two months
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)
Time Frame: Through participant study completion, an average of two months
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)
Time Frame: Through participant study completion, an average of two months
DKEFS Verbal Fluency Task will evaluate verbal fluency.
Through participant study completion, an average of two months
Working Memory Assessment via N-Back Task
Time Frame: Through participant study completion, an average of two months
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)
Time Frame: Through participant study completion, an average of two months
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
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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")
Time Frame: Through participant study completion, an average of two months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jing Wang, PhD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings