Tandem DBS for Parkinson's Disease: A Pilot Study Utilizing STN/GPi + Hypothalamic Stimulation
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 11-007086
NCT ID: NCT01563341
Sponsor Protocol Number: 11-007086
About this study
Does dual hemispheric stimulation of the subthalamic nucleus (STN) and fornix/hypothalamus potentially improve cognitive function in patients with Parkinsons disease.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- All patients will be enrolled from the practice of the primary investigator.
- PD patients in whom optimal medical therapy has failed.
- All patients will have responsivity to levodopa.
- Individuals with normal or mild cognitive impairment.
Exclusion Criteria:
- Clinically significant dementia
- Other significant neurological or psychiatric disease
- Previous brain surgery including pallidotomy or thalamotomy
- Previous placement of other implantable devices
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Ryan Uitti, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available