Coordinated Reset Deep Brain Stimulation for Parkinson's Disease
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- DBS
Treatment groups
24 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov