Recruitment

Recruitment Status
Completed
Estimated Enrollment
24

Summary

Conditions
Parkinson's Disease
Type
Interventional
Phase
Early Phase 1
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Other

Participation Requirements

Min Age
18
Max Age
80
Gender
Both

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...

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: Parkinson's Participants Only: A neurological examination will be performed by administering several clinical scaled. These clinical scales include the Unified Parkinson's Disease Rating Scale (UPDRS), the self-report Parkinson's Disease Quality of life scale (PDQ-39), MMSE instrument for cognitive (or memory) testing, and Beck Depression Inventory (BDI II) for evaluation of mood and depressive symptoms. The PDQ-39, MMSE, and BDI will each only be administered once and therefore will not be repeated at every study visit. The investigators will determine individual motor evoked potential (MEP) thresholds before beginning the study treatment. MEP will be recorded from a muscle located between the right thumb and index finger, and then from the left thumb and index finger. MEP threshold refers to the amount of stimulation to the brain that is required to activate muscle cells enough to appear on an electromyography (EMG), which records electrical potential in muscle through electrodes placed on the skin. The investigators will use TMS to test motor cortex functions. For these tests, participants will sit in a chair that looks like the one at the 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 opposite side. Recordings from both hands will be made using the magnetic coils placed on scalp. The investigators will collect data about the muscles of both the upper and lower limbs with a wireless EMG procedure. To do this, small wireless sensors will be placed on the skin over both arm and leg muscles. Participants will be asked to sit in a chair and perform movements with the upper and lower limbs while the EMG records measurements about movement activity. This procedure will be conducted separately for the upper and lower limbs. Participants who have provided consent will be videotaped during the visits. Side effects and adverse events pertaining to this study will be recorded at each visit.

Locations

Gainesville, Florida, 32607
Gainesville, Florida, 32607

Tracking Information

NCT #
NCT02012647
Collaborators
Not Provided
Investigators
  • Principal Investigator: Aparna Wagle Shukla, MD University of Florida Center for Movement Disorders and Neurorestoration
  • Aparna Wagle Shukla, MD University of Florida Center for Movement Disorders and Neurorestoration