Coordinated Reset Deep Brain Stimulation for Parkinson's Disease

NCT ID: NCT07340073

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2031-07-01

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

Study Design

• Allocation Method: NA
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: ACTIVE_COMPARATOR

DBS

Intervention Type: DEVICE

Deep Brain Stimulation

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)

Group Type: ACTIVE_COMPARATOR

DBS

Intervention Type: DEVICE

Deep Brain Stimulation

Interventions

DBS

Deep Brain Stimulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Central Contacts

Marina Bryants, CCRP, BS

Role: CONTACT

bryan371@umn.edu

612-624-3035

Other Identifiers

NEUR-2025-34279

Identifier Type: -

Identifier Source: org_study_id