跳至主要内容
临床试验/NCT01671527
NCT01671527已完成不适用

Pathophysiological Insights Into STN DBS for Primary Cervical Dystonia

University of Florida1 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
1
主要终点
The body's response to transcranial magnetic stimulation (TMS)

研究概览

简要总结

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.

详细描述

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 muscle cells enough to appear on an electromyography (EMG), which records electrical potential in muscle through electrodes placed on the skin.
  5. We will test your sensory system and its interaction with the motor cortex by using transcranial magnetic Stimulation (TMS). For these tests, you will sit in a chair that looks like one you would find at the dentist's office. A nerve stimulator will be placed at the wrist of your right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of your head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of your head.
  6. We will spend an additional 30 minutes performing a protocol that allows for testing of plasticity changes in the brain. This protocol is called paired associative stimulation (PAS). The median nerve in your wrist and the TMS coil over your head undergo repeated paired stimulation. Such repeated pairing builds plasticity effect in the motor cortex. MEP, as explained earlier, is recorded before and after this protocol.
  7. Subjects who have provided consent will be videotaped during this visit.

Study Visit 2:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

The body's response to transcranial magnetic stimulation (TMS)

时间窗: 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.

次要结局

  • Clinical assessment of dystonia severity(10 minutes at each study visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验