Trial record 5 of 1298 for:    "Parkinson's Disease"

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

This study is currently recruiting participants.
Verified March 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: March 24, 2014
Last verified: March 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 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. The investigators will use Transcranial Magnetic Stimulation (TMS), which is painless and non-invasive, to help learn whether the electrical changes in the brain have any relation to the physical benefits patients with Parkinson's Disease receive from DBS surgery.


Condition Intervention Phase
Parkinson's Disease
Procedure: Transcranial Magnetic Stimulation (TMS)
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: 3 weeks (1 time point spread over 3 weeks) ] [ 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:
  • Unified Parkinson's disease rating scale [ Time Frame: 3 weeks (1 time point spread over 3 weeks) ] [ Designated as safety issue: No ]
    The Unified Parkinson's Disease Rating Scale (motor section) 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.

  • Transcallosal Pathway Excitability [ Time Frame: 3 weeks (1 time point spread over 3 weeks) ] [ 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).


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 Deep Brain Stimulation (DBS) surgery for both sides. They have been followed at The University of Florida (UF) for a period of at least six months after the surgery for two sides have been performed. These participants will undergo Transcranial Magnetic Stimulation (TMS) 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.
Placebo Comparator: Healthy matched controls
These participants do not have Parkinson's Disease, nor have they had Deep Brain Stimulation surgery, and are a healthy matched control. These participants will undergo Transcranial Magnetic Stimulation (TMS) 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.

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 2 study visits and will include a review of medical history. There will be a neurological exam (physical exam). Women of child bearing potential will take a urine pregnancy test. If applicable, the medications used to treat Parkinson's Disease (PD) symptoms will be reviewed and subjects will be asked to discontinue them for some hours on the days of the 2 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.

Study Visits 1 and 2:

Study visits 1 and 2 will be spaced within a week of each other. Parkinson's disease participants will be studied under four conditions. 1) DBS stimulator will be turned OFF for both sides. 2) DBS stimulator will be turned ON for the right side. 3) DBS stimulator will be turned ON for the left side. 4) DBS stimulator will be turned ON for both sides. Two of these conditions will be randomly picked and studied each day. Participants will be asked not to take PD medications for approximately 12 hours prior to the scheduled visit time. Physiological tests will be performed in the morning and then routine oral medications will be provided.

Tests performed for all study participants at each Study Visit:

  1. Females of child-bearing potential will take a urine pregnancy test again only during the first study visit.
  2. A neurological examination will be performed. Scales used for routine clinical assessment of Parkinson's Disease will be video recorded, if the participant has given written permission on the informed consent. These scales will be the Unified Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Quality of life scale (PDQ-39) which subjects will fill out , Mini Mental (MMSE) instrument for cognitive (or memory) testing and Beck Depression Inventory (BDI II) for evaluation of mood. If it is determined that participants are feeling depressed or suicidal during any of these assessments, the principal investigator will make the appropriate treatment referral.
  3. 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.
  4. 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.

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 deep brain stimulation (DBS)
  • Completed follow up of six months is maintained post surgery

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 seizure
  • Having a positive pregnancy test
  • Presence of a terminal illness
  Contacts and Locations
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: Simone Roberts, BS 352-273-5566 simone.roberts@neurology.ufl.edu

Locations
United States, Florida
University of Florida Center for Movement Disorders and Neurorestoration Recruiting
Gainesville, Florida, United States, 32607
Contact: Stacy Merritt, MA    352-273-5614    stacy.merritt@neurology.ufl.edu   
Contact: Aparna Wagle Shukla, MD    352-273-5550    aparna.shukla@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: March 24, 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
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 April 15, 2014