University of Florida
Gainesville, Florida, 32607, United States
NCT Number: NCT02012647
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.
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Notify Me18 year–80 year
All sexes
Interventional
Early Phase 1
Gainesville, Florida, 32607, United States
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants sit in a chair that looks like one in a dentist's office. A magnetic coil will be placed on the scalp on one side of the head, overlying the brain's motor cortex to stimulate the brain's output to the muscles in the opposite hand. A second magnetic coil will be placed on the scalp of the opposite side. Recordings from both hands will be made using the magnetic coils placed on scalp. Results will be compared for participants with and without Parkinson's Disease.
Participants will be asked to move their upper and lower limbs while seated in a chair. Wireless EMG sensors placed on arm and leg muscles will record measurements during this procedure. Upper and lower limb testing will be performed separately.
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.
Time frame: As few as 2 days and up to 4 months
The Unified Parkinson's Disease Rating Scale (UPDRS) is used by neurologists to rate the motor impairment of people with Parkinson's Disease. The rater obtains the score by observation and questioning the participant. Higher scores represent greater impairment and scores range from 0-108.
The data collected from the UPDRS will be compared to physiological data collected with EMG during limb movement tasks. These tasks are used to gather data about skeletal muscle movements. The EMG data will be evaluated individually with an EMG paradigm considering velocity of movement and both antagonist and agonist burst patterns.
Time frame: As few as 2 days and up to 4 months
The investigators will examine the effects of unilateral and bilateral stimulation on the excitability of transcallosal pathway, using specific parameters of Transcranial Magnetic Stimulation (TMS).
Time frame: One day
Physiological data will be collected from healthy controls with EMG during limb movement tasks. These tasks are used to gather data about skeletal muscle movements. The EMG data will be evaluated individually with an EMG paradigm considering velocity of movement and both antagonist and agonist burst patterns.
University of Florida
Other
Evaluating Cortical Physiology Following Unilateral and Bilateral Subthalamic Deep Brain Stimulation in Parkinson's Disease
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