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Coordinated Reset Deep Brain Stimulation for Parkinson's Disease

Phase I Interventional Parkinson's Disease (PD) Deep Brain Stimulation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DBS.
Who it may be relevant to
Registry conditions: Parkinson's Disease (PD), Deep Brain Stimulation. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device DBS
    Deep Brain Stimulation

Primary outcome measures

  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III [Time frame: Through participant study completion, an average of two months]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07340073 · NEUR-2025-34279

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗