Clinical and Physiological Studies of Tremor Syndromes
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03027310 |
|
Recruitment Status :
Recruiting
First Posted : January 23, 2017
Last Update Posted : October 18, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease |
|---|
| Parkinson Disease Dystonia Essential Tremor |
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 action 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) training studies for investigators, as well as 4) technical development studies.
Study population:
We intend to up to 300 patients with essential tremor and other isolated action tremor syndromes, as well as 150 healthy volunteers.
Design:
This is a non-hypothesis driven study involving standardized phenotyping as well as thematic sub-studies. After patients and healthy volunteers complete a screening visit, patients will undergo a standardized phenotyping visit including clinical rating scales as well as electrophysiological tremor-workup. Patient and healthy controls may then be enrolled in sub-studies, which are pertinent to the theme of this protocol. If a sub-study leads to results of interest, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory sub-studies performed in the present protocol. At any given time, no more than 5 sub-studies can be actively accruing subjects concurrently.
Outcome measures:
Outcome measures applied in this protocol involve methods for tremor phenotyping such as clinical rating scales and questionnaires, electrophysiological tremor studies, videotaped exam, as well as digitizing based tasks. During the thematic studies focused on the neurophysiological characterization of tremor syndromes, the following outcome measures will be applied: EMG: we will analyze tremor signals using spectral analyses, coherence analyses, and in combination with accelerometry, EEG, MEG, and TMS to explore tremor-networks. MRI: we will analyze measures such as the amplitude of the BOLD signal (fMRI); tractography between seed and target regions of interest (using DTI); morphometry of brain regions (using VBM); and different neurotransmitter levels in brain regions of interest (using MRS). EEG and MEG: we will quantify measures such as corticomuscular coherence, event- or task-related potentials, synchronization/desynchronization, and coherence between sensors or sources located close to the brain areas of interest. TMS: we will analyze measures such as MEP amplitude and central conduction time, as well as measures of cortical excitability and inhibition paradigms. Behavioral measures: we will quantify measures of voluntary movement involving tremor, reaction times to initiate movements, EMG patterns, movement kinematics (position, velocity, acceleration, curvature), eye movement. Actigraphy: We will quantify continuous recordings of motion sensors involving multiaxial accelerometers and gyroscopes. Furthermore, we may measure autonomic data during the course of experiments (such as blood pressure, skin conductance, and respiratory rate) which would correlate to the outcome measures.
| Study Type : | Observational |
| Estimated Enrollment : | 450 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Clinical and Physiological Studies of Tremor Syndromes |
| Study Start Date : | January 6, 2017 |
| Estimated Primary Completion Date : | January 1, 2022 |
| Estimated Study Completion Date : | January 1, 2022 |
- Exploratory association of clinical and phenotypic data of tremor with neurophysiological study outcomes. [ Time Frame: Study Completion ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
- 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 thematic 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 thematic study visits because both agents may modify the activity of the brain during the study.
EXCLUSION CRITERIA 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027310
| Contact: Elaine P Considine, R.N. | (301) 435-8518 | considinee@ninds.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov | |
| Principal Investigator: | Dietrich K Haubenberger, M.D. | National Institute of Neurological Disorders and Stroke (NINDS) |
Additional Information:
| Responsible Party: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT03027310 History of Changes |
| Other Study ID Numbers: |
170035 17-N-0035 |
| First Posted: | January 23, 2017 Key Record Dates |
| Last Update Posted: | October 18, 2018 |
| Last Verified: | September 10, 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
|
Dystonic Tremor Essential Tremor Tremor Voice Tremor Parkinson's Disease |
Additional relevant MeSH terms:
|
Parkinson Disease Dystonia Tremor Essential Tremor Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Dyskinesias Neurologic Manifestations Signs and Symptoms |