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

University of Minnesota (UMN)

Status and phase: Not yet enrolling; Phase 1

Conditions: Deep Brain Stimulation; Parkinson's Disease (PD)

Treatments: Device: DBS

Study type: Interventional

Funder types: Other

Identifiers

NCT07340073

NEUR-2025-34279

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Crossover Assignment

Masking: Double Blind

---

24 participants in 2 patient groups

CR-DBS

Active Comparator group

Description:

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)

Treatment:

Device: DBS

T-DBS

Active Comparator group

Description:

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)

Treatment:

Device: DBS