Parkinson Disease
Conditions
Keywords
Parkinson Disease, Deep Brain Stimulation, Diffusion Tensor Imaging
Brief summary
In the proposed pilot project, MRI data will be prospectively collected to show the feasibility of the segmentation algorithm and the potential relation to final lead positioning. Patients will be selected from those undergoing GPi DBS placement. This pilot data will serve as a basis for pursuing funding for a larger trial evaluating the prospective ability of the 3T targeting study to improve outcomes and decrease complications in GPi DBS placement. Improved outcomes and patient experience would be expected to further contribute to our facility as a center of excellence for treatment of movement disorders.
Interventions
DEVICEDBS Programming
DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient with the diagnosis of Parkinson's Disease selected for placement of globus pallidus internus (GPi) deep brain stimulator (DBS)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III) | 3 months | Pre-operative and post-operative UPDRS-III will be assessed to measure symptom improvement and correlated with imaging data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| GPi DBS Patients selected to undergo GPi DBS placement will be eligible for enrollment in the study. In addition to standard-of-care tests, subjects will undergo an MRI consisting of the proposed novel imaging protocol prior to placement of DBS. The patient will subsequently undergo standard-of-care therapy for DBS placement. Once the stimulator has been programmed post-operatively, the stimulation parameters and corresponding clinical changes will be collected and used to model the volume of activated tissue. The patient will additionally undergo a follow-up MRI used to localize the electrode within the brain to further localize the volume of activated tissue.
DBS Programming: DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms. | 1 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Surgical plan was altered-subject not eligible | 1 |
Baseline characteristics
| Characteristic | GPi DBS |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Change in Unified Parkinson's Disease Rating Scale III (UPDRS-III)
Pre-operative and post-operative UPDRS-III will be assessed to measure symptom improvement and correlated with imaging data.
Time frame: 3 months
Population: Study was terminated due to delays in IRB approval and interval start of a competing study. Surgical plan was altered-subject not eligible. Data was not collected or analyzed.