Clinical Trial: Insights Into Deep Brain Stimulation (DBS) for Cervical Dystonia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Pathophysiological Insights Into STN DBS for Primary Cervical Dystonia

Brief Summary:

The purpose of this research study is to determine the physical brain changes in people with cervical dystonia after deep brain stimulation (DBS) surgery and as compared to healthy controls. We will do this by measuring your body's response to transcranial magnetic stimulation (TMS) before and/or after DBS surgery.

TMS is a non-invasive procedure during which you sit in a chair that looks like one you would find at the dentist's office. A nerve stimulator is placed on the wrist of the right hand to stimulate the median nerve; the intensity of the nerve stimulator is gradually increased until the right thumb begins to twitch. A magnetic coil is 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.

If you are a control subject, and therefore will not/have not have DBS surgery, we will measure the body's response to TMS for comparison purposes. We expect that the electrical differences in the brain may be related to the physical benefits some patients with primary cervical dystonia receive from DBS surgery.


Detailed Summary:

Subjects will participate in 1-3 visits, based on eligibility, as described below:

Study Visit 1: Baseline

  • This visit applies to subjects with cervical dystonia who are planning DBS surgery in the next 1-4 weeks
  • This visit applies to subjects with cervical dystonia who are not planning DBS surgery

  • This visit (except #3) applies to healthy control subjects; this is the only visit for healthy control subjects

    1. A neurological examination with special attention to the sensory system will be performed. The sensory system is the system by which the brain receives and perceives feelings from different parts of the body.
    2. Women of child-bearing potential will be given a urine pregnancy test to evaluate pregnancy status.
    3. DYSTONIA SUBJECTS ONLY: Clinical assessment of dystonia will be performed by administering several scales and measures, including: the Toronto Western Cervical Dystonia Rating Scale (TWSTRS), the Short Form (SF-36) scale for quality of life assessment, Visual Analog Scale (VAS) for assessment of dystonia and pain severity, the Mini Mental Status Examination (MMSE) for cognitive testing, and the Beck Depression Inventory (BDI II), for evaluation of mood.
    4. We will determine your individual motor evoked potential (MEP) threshold before beginning the study treatment. Your MEP will be recorded from a muscle located between the right thumb and index finger on your right hand, and then on your left hand. MEP threshold refers to the amount of stimulation to the brain that is required to activate
      Sponsor: University of Florida

      Current Primary Outcome: The body's response to transcranial magnetic stimulation (TMS) [ Time Frame: From 1 day to 10 months, based on eligibility ]

      The purpose of this research study is to determine the physical brain changes in people with cervical dystonia after deep brain stimulation (DBS) surgery. We will do this by measuring your body's response to transcranial magnetic stimulation (TMS) before and/or after DBS surgery, unless you are a control subject. If you are a dystonia control subject (not planning DBS), we will measure your body's response to TMS on two occasions. If you are healthy control subject, we will measure your body's response to TMS on one occasion.

      These tests should help us learn whether the electrical changes in the brain have any relation to the physical benefits some patients with primary cervical dystonia receive from DBS surgery.



      Original Primary Outcome: The body's response to Transcranial Magnetic Stimulation (TMS). [ Time Frame: 7-9 months for entire study, 1 day for control subjects ]

      The purpose of this research study is to determine the actual physical brain changes in people with cervical dystonia after Deep Brain Stimulator (DBS) surgery. We will do this by measuring your body's response to Transcranial Magnetic Stimulation (TMS) before and after DBS surgery, unless you are a control subject. If you are control subject, we will measure your body's response to TMS on one occasion for comparison purposes.

      For cervical dystonia patients, we plan to perform TMS one month before Deep Brain Stimulator (DBS) surgery, and again at 3- and 6-months after DBS surgery. These repeated tests should help us learn whether the electrical changes in the brain have any relation to the physical benefits patients with primary cervical dystonia receive from DBS surgery.



      Current Secondary Outcome: Clinical assessment of dystonia severity [ Time Frame: 10 minutes at each study visit ]

      Dystonia will be evaluated at each study visit using: the Toronto Western Cervical Dystonia Rating Scale (TWSTRS); the Visual Analogue Scale (VAS) for assessment of dystonia pain and severity


      Original Secondary Outcome:

      Information By: University of Florida

      Dates:
      Date Received: August 20, 2012
      Date Started: August 2012
      Date Completion:
      Last Updated: June 9, 2016
      Last Verified: June 2016