Subthalamic Deep Brain Stimulation (DBS) in Parkinson's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Florida
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02012647
First received: November 1, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Procedure: Transcranial Magnetic Stimulation (TMS)
Procedure: Motor Physiology Testing
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Evaluating Cortical Physiology Following Unilateral and Bilateral Subthalamic Deep Brain Stimulation in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Motor Cortex Excitability [ Time Frame: As few as 1 days and up to 4 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Relation between Unified Parkinson's Disease Rating Scale outcomes and physiological measures [ Time Frame: As few as 2 days and up to 4 months ] [ Designated as safety issue: No ]

    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.


  • Transcallosal Pathway Excitability [ Time Frame: As few as 2 days and up to 4 months ] [ Designated as safety issue: No ]
    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).

  • Physiological Measures [ Time Frame: One day ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 24
Study Start Date: August 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: People with Parkinsons Disease
Participants have been diagnosed with Parkinson's Disease, and as recommended by their physicians, have undergone DBS surgery for both sides of the brain. These participants will undergo TMS and motor physiology testing, and results will be compared to participants without Parkinson's Disease.
Procedure: Transcranial Magnetic Stimulation (TMS)
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.
Procedure: Motor Physiology Testing
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.
Placebo Comparator: Healthy Controls
These participants do not have Parkinson's Disease, nor have they had DBS surgery, and are a healthy controls. These participants will undergo TMS and motor physiology testing, and results will be compared to participants with Parkinson's Disease.
Procedure: Transcranial Magnetic Stimulation (TMS)
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.
Procedure: Motor Physiology Testing
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.

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Participants who have provided consent will be videotaped during the visits.
  6. Side effects and adverse events pertaining to this study will be recorded at each visit.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012647

Contacts
Contact: Amanda Eilers, BA 352-294-5434 amanda.eilers@neurology.ufl.edu
Contact: Stacy Merritt, MA 352-273-5614 stacy.merritt@neurology.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32607
Contact: Amanda Eilers, BA    352-294-5434    amanda.eilers@neurology.ufl.edu   
Principal Investigator: Aparna Wagle Shukla, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Aparna Wagle Shukla, MD University of Florida Center for Movement Disorders and Neurorestoration
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02012647     History of Changes
Other Study ID Numbers: 21-2013, 40115065-2
Study First Received: November 1, 2013
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
parkinson
parkinson disease
parkinson's
parkinson's disease
parkinsons
parkinsons disease
PD
TMS
DBS
transcranial magnetic stimulation
deep brain stimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 19, 2014