Parkinson's Disease (PD)Phase 1CR DBS PDNCT07340073
Coordinated Reset Deep Brain Stimulation for Parkinson's Disease
A Phase 1 study testing DBS in people with Parkinson's Disease (PD) and Deep Brain Stimulation, run by University of Minnesota.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson's Disease (PD), Deep Brain Stimulation
- What is being tested?
- DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jul 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Parkinson's Disease (PD), Deep Brain Stimulation
- Being tested
- DBS
- Keywords
- Deep Brain Simulation, Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBSDevice
Deep Brain Stimulation
| Study group | Role | What they receive |
|---|---|---|
| CR-DBS | Active comparator | 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) Receives: Device: DBS |
| T-DBS | Active comparator | 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) Receives: Device: DBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through participant study completion, an average of two months
Secondary outcomes (22)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through participant study completion, an average of two months
Verbal Fluency Measurement (DKEFS)
DKEFS Verbal Fluency Task will evaluate verbal fluency.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through participant study completion, an average of two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's Disease (PD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Wang, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07340073
- Sponsor's protocol ID
- NEUR-2025-34279
- Acronym
- CR DBS PD
- Status last verified
- Oct 2026
- First submitted
- 13 Nov 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coordinated Reset Deep Brain Stimulation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07340073
- Acronym / sponsor ID
- CR DBS PD / NEUR-2025-34279
- Conditions
- Parkinson's Disease (PD), Deep Brain Stimulation
- Keywords
- Deep Brain Simulation, Parkinson's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jul 2031 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CR-DBS | Active comparator | Device: DBSRandomized to either T-DBS occurring first or CR-DBS occurring first (50/50 chance of being assigned to either, but will be assessing both) |
| T-DBS | Active comparator | Device: DBSRandomized to either T-DBS occurring first or CR-DBS occurring first (50/50 chance of being assigned to either, but will be assessing both) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBSDeep Brain Stimulation | Device | CR-DBS, T-DBS |
Primary outcome
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.
22 secondary outcomes
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
Amplitude Decrement via Rapid Alternating Movements (RAMs)
Time frame: Through participant study completion, an average of two months
Forearm Rigidity
Time frame: Through participant study completion, an average of two months
Cognitive Measurements (TMT-B)
Time frame: Through participant study completion, an average of two months
Verbal Fluency Measurement (DKEFS)
Time frame: 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
Dyskinesia Assessment via Rush Dyskinesia Rating Scale (RDRS)
Time frame: 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
Step Length ("Steady-State Gait")
Time frame: 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
Cadence ("Steady-State Gait")
Time frame: 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
Step Asymmetry ("Steady-State Gait")
Time frame: 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
Frequency of Freezing of Gait ("Steady-State Gait")
Time frame: 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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jing Wang, PhD principal investigator
University of Minnesota
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DBS in people with Parkinson's Disease (PD) and Deep Brain Stimulation, run by University of Minnesota.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaylee Lymon, PhD (612-626-0877, klymon@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (time frame: Through participant study completion, an average of two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.