Coordinated Reset Deep Brain Stimulation for Parkinson's Disease

NCT07340073 | Not Yet Recruiting Phase 1 FDA Device

• 1 other identifier: NEUR-2025-34279
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Keywords

Deep Brain Simulation; Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

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

  Through participant study completion, an average of two months

• Amplitude Decrement via Rapid Alternating Movements (RAMs)

  Through participant study completion, an average of two months

• Forearm Rigidity

  Through participant study completion, an average of two months

• Cognitive Measurements (TMT-B)

  Through participant study completion, an average of two months

• Verbal Fluency Measurement (DKEFS)

  Through participant study completion, an average of two months

Study Arms (2)

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)

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)

Device: DBS

Interventions

DBS DEVICE

Deep Brain Stimulation

CR-DBS; T-DBS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Jing Wang, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marina Bryants, CCRP, BS

CONTACT

612-624-3035; bryan371@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: January 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share