Clinical and Physiological Studies of Tremor Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- methods for tremor phenotyping
研究概览
简要总结
Background:
Researchers have some data on how the brain controls movement and why some people have tremor. But the causes of tremor are not fully known. Researchers want to study people with tremor to learn about changes in the brain and possible causes of tremor.
Objective:
To better understand how the brain controls movement, learn more about tremor, and train movement disorder specialists.
Eligibility:
People ages 18 and older with a diagnosed tremor syndrome
Healthy volunteers ages 18 and older
Design:
Participants will be screened with:
- Medical history
- Physical exam
- Urine tests
- Clinical rating scales
- Health questions
- They may have electromyography (EMG) or accelerometry. Sensors or electrodes taped to the skin measure movement.
Participation lasts up to 1 year.
Some participants will have a visit to examine their tremor more. They may have rating scales, EMG, and drawing and writing tests.
Participants will be in 1 or more substudies. These will require up to 7 visits. Visits could include the following:
- EMG with accelerometry
- Small electrodes taped on the body give small electric shocks that stimulate nerves.
- MRI: Participants lie on a table that slides into a cylinder that takes pictures of the body while they do simple tasks.
- Small electrodes on the scalp record brain waves.
- A cone with detectors on the head measures brain activity while participants do tasks.
- A wire coil held on the scalp gives an electrical current that affects brain activity.
- Tests for thinking, memory, smell, hearing, or vision
- Electrodes on the head give a weak electrical current that affects brain activity.
- Photographs or videos of movement
Participant data may be shared with other researchers.
详细描述
Objectives
The purpose of this protocol is to study the phenotypic spectrum and the pathophysiology of tremor syndromes by performing small behavioral, electrophysiological and neuroimaging sub-studies. The protocol includes techniques with minimal risk (standard clinical evaluation, MRI, EEG, peripheral nerve stimulation, single and paired pulse TMS) and certain sub-studies may involve healthy volunteers. This protocol aims to study neurophysiological and behavioral outcomes in defined groups of patients with tremor syndromes, to inform future hypothesis-driven and confirmatory studies, which will be developed and submitted as separate protocols. For this purpose, we aim to conduct 1) pilot sub-studies, 2) individual patient investigations, 3) technical development studies.
Study population
We intend to enroll up to 300 patients with essential tremor and other isolated action tremor syndromes, as well as 150 healthy volunteers.
Design
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA FOR TREMOR PATIENTS:
- •Patients diagnosed with a tremor syndrome, including, but not limited to
- •Essential tremor (per definition of the Tremor Research Group)
- •Parkinson disease (per UK Brain Bank criteria)
- •Focal tremor such as isolated head tremor, voice tremor
- •Task-specific tremor such as primary writing tremor
- •Orthostatic tremor
- •Patients with other tremor syndromes such as dystonic tremor, intention tremor, etc.
- •Age 18 or older
- •Able to give informed consent
- •Agree to not drink caffeine or alcohol for 12 hours before phenotyping and selected sub-study visits because both agents can modify brain activity and may confound outcome measures.
- •INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
- •Age 18 or older.
- •Able to give informed consent.
- •Agree to not consume caffeine or alcohol for 12 hours before selected sub-study visits because both agents may modify the activity of the brain during the study.
排除标准
- •FOR TREMOR PATIENTS:
- •Problematic alcohol use, as defined by a score of 8 or higher on the WHO Alcohol Use Disorders Identification Test (AUDIT).
- •History of a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of seizures.
- •History of psychotic disorder, Bipolar Disorder or a current depressive episode.
- •History or clinical evidence of another neurologic disorder than a tremor syndrome as defined above, which may interfere with the ability to comply with protocol requirements or interpret the obtained results.
- •EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
- •Have abnormal findings of clinical significance on the neurological examination that may affect the scientific integrity of the study
- •Problematic alcohol use, as defined by a score of 8 or higher on the WHO Alcohol Use Disorders Identification Test (AUDIT)
- •History of a brain tumor, a stroke, traumatic brain injury, epilepsy or a history of seizures.
- •History of psychotic disorder, Bipolar Disorder or a current depressive episode.
- •ADDITIONAL EXCLUSION CRITERIA FOR MOVEMENT DISORDER PATIENTS AND HEALTHY VOLUNTEERS SPECIFICALLY FOR MRI:
- •We will follow the NMR Center guidelines for MR safety.
- •Some of the exclusions are:
- •Have non-MRI compatible metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain or on blood vessels, cochlear implants, artificial heart valves or ferromagnetic fragments in the eye or oral cavity as these make having an MRI unsafe.
- •Unable to lie flat on the back for the expected length of the experiment.
- •Have uncontrolled movements of the head.
- •Have an abnormality on the brain imaging or neurologic examination not related to the diagnosis.
- •Uncomfortable being in a small space for the expected length of the experiment.
- •Non-removable body piercing or tattoo posing MRI risk
- •Pregnancy.
- •ADDITIONAL EXCLUSION CRITERIA FOR TREMOR PATIENTS AND HEALTHY VOLUNTEERS FOR TMS AND MRI:
- •Ferromagnetic metal in the cranial cavity or eye, e.g. aneurysm clip or ocular foreign body.
- •Implanted electronic device including deep brain stimulation systems.
研究组 & 干预措施
Healthy Volunteers
adult healthy volunteers
tremor patients
adult patients with tremor
结局指标
主要结局
methods for tremor phenotyping
时间窗: throughout protocol
clinical rating scales and questionnaires, electrophysiological tremor studies, videotaped exam, as well as digitizing based tasks. EMG, EEG, MEG, TMS, MRI. Behavioral measures such as reaction times to initiate movements, EMG patterns, movement kinematics, eye movement.
次要结局
未报告次要终点