Evaluating Cortical Physiology Following Unilateral and Bilateral Subthalamic Deep Brain Stimulation in Parkinson's Disease
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- Motor Cortex Excitability
Study Overview
Brief Summary
The purpose of this study is to examine the brain changes in people with Parkinson's Disease (PD) after they get deep brain stimulation (DBS) surgery, compared with people who do not have Parkinson's Disease. Treatment of Parkinson's disease is often difficult and challenging. Deep brain stimulation is an established surgical treatment that is effective for the treatment of PD, but the details of why it helps are not known. In order to achieve maximum benefits from this treatment, it is important to understand how it changes the brain. Specifically, the investigators will study electrophysiology, which is the study of how the brain conducts electrical messages to the rest of the body. To do this, the investigators will use transcranial magnetic stimulation (TMS), which is a painless and non-invasive procedure. They will also conduct motor physiology experiments of the upper and lower limbs to collect data about skeletal muscle movement. The data from this study will help explain whether the electrical changes in the brain have any relation to the physical benefits patients with Parkinson's Disease sometimes receive from DBS surgery.
Detailed Description
Screening evaluation: The Investigators will ask questions to see if the participant qualifies to be in the study. The screening visit will occur up to 4 months before the first study visit, and can be scheduled to occur on the same day as the first study visit. This evaluation will include a review of medical history and clinical findings related to Parkinson's Disease (if applicable). There may be a neurological exam (physical exam). Women of child bearing potential will take a urine pregnancy test. If applicable, the medications currently used to treat Parkinson's Disease symptoms will be reviewed and subjects will be asked to discontinue them for some hours on the days of the study visits. The investigators do not expect concerns or unwanted consequences arising either from discontinuing the Parkinson's Disease medications or turning off the DBS stimulator for the duration of time proposed in the study.
Participants will be studied under 4 conditions, over a span of as few as two days to as long as two months. The four Conditions are : 1) The DBS stimulator will be turned OFF for both sides. 2) The DBS stimulator will be turned ON for the right side. 3) The DBS stimulator will be turned ON for the left side. 4) The DBS stimulator will be turned ON for both sides. The order of these conditions will be picked randomly.
Participants will be asked not to take PD medications for approximately 12 hours prior to the scheduled visit time, and until after the physiological testing.
Healthy controls will be studied on only one occasion, as they do not have DBS.
Tests performed for each study condition:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Aged 18-80 years
- •Diagnosis of Parkinson's Disease with bilateral subthalamic nucleus (STN) DBS
Exclusion Criteria
- •Cardiac pacemakers
- •Need for diathermy
- •Repeat MRI scanning
- •Anticoagulant therapy
- •Previous neuro surgical procedure or ablative therapy
- •Frank dementia according to cognitive screening
- •History of seizures
- •Pregnancy
- •Presence of a terminal illness
Outcomes
Primary Outcomes
Motor Cortex Excitability
Time Frame: As few as 1 days and up to 4 months
We will measure Motor Cortex Excitability by examining circuitries of inhibition found in the motor cortex which have a reduced function in Parkinson's Disease.
Secondary Outcomes
- Transcallosal Pathway Excitability(As few as 2 days and up to 4 months)
- Relation between Unified Parkinson's Disease Rating Scale outcomes and physiological measures(As few as 2 days and up to 4 months)
- Physiological Measures(One day)