Parkinson DiseaseNCT03027310
Clinical and Physiological Studies of Tremor Syndromes
An observational study of Parkinson Disease and Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Dystonia, Essential Tremor
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2017to 23 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Experimental subjects will include healthy volunteer subjects and patients with tremor syndromes including, but not limited to ET, PD-tremor, and dystonic tremor. The diagnosis will be made by a movement disorders neurologist at the NINDS movement disorders clinics. Healthy volunteers will be recruited for the following purposes: (1) to optimize data acquisition and analysis techniques; and (2) to serve as negative controls for clinical, imaging, and biological variables measured in the patient cohorts. Without data obtained from healthy volunteers, there is no way to determine whether subtle findings in tremor (e.g., physiological tremor) are truly abnormal. The inclusion of healthy volunteers therefore allows to correctly threshold and quantify observed abnormalities. Healthy volunteers may also include non-affected family members of patients with tremor
Who may be able to join
- 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
Show all 13Show fewer
- 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.
- 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.
Who cannot join
- 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.
- 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)
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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
This is a non-hypothesis driven study involving standardized phenotyping After patients and healthy volunteers complete a screening visit, patients will undergo a standardized phenotyping visit including clinical rating scales as well as electrophysiological tremorworkup. Patient and healthy controls may then be enrolled in sub-studies, and if a substudy 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.
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 sub-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 co ductance, and respiratory rate) which would correlate to the outcome measures.
- Conditions
- Parkinson Disease, Dystonia, Essential Tremor
- Keywords
- Dystonic Tremor, Essential Tremor, Parkinsonism, Voice Tremor, Parkinson's Disease, Natural History
- Medical subject headings
- Parkinson Disease, Dystonia, Essential Tremor, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | adult healthy volunteers | |
| tremor patients | adult patients with tremor |
What is being measured
The primary outcome is the main question the study is designed to answer.
methods for tremor phenotyping
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.
Measured: throughout protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2017 (estimated)
- Study start5 May 2017
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Debra J Ehrlich, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027310
- Sponsor's protocol ID
- 170035
- Other IDs
- 17-N-0035
- Status last verified
- 16 Sep 2026
- First submitted
- 18 Jan 2017
- Last updated
- 18 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share all collected deidentified IPD at the request of others after publication. Data will not be sent until the applicable approvals and data sharing agreement has been obtained.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Physiological Studies of Tremor Syndromes
- ClinicalTrials.gov ID
- NCT03027310
- Acronym / sponsor ID
- 170035
- Conditions
- Parkinson Disease, Dystonia, Essential Tremor
- Keywords
- Dystonic Tremor, Essential Tremor, Parkinsonism, Voice Tremor, Parkinson's Disease, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 5 May 2017 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 23 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
This is a non-hypothesis driven study involving standardized phenotyping After patients and healthy volunteers complete a screening visit, patients will undergo a standardized phenotyping visit including clinical rating scales as well as electrophysiological tremorworkup. Patient and healthy controls may then be enrolled in sub-studies, and if a substudy 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.
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 sub-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 co ductance, and respiratory rate) which would correlate to the outcome measures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –adult healthy volunteers |
| tremor patients | – | –adult patients with tremor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Experimental subjects will include healthy volunteer subjects and patients with tremor syndromes including, but not limited to ET, PD-tremor, and dystonic tremor. The diagnosis will be made by a movement disorders neurologist at the NINDS movement disorders clinics. Healthy volunteers will be recruited for the following purposes: (1) to optimize data acquisition and analysis techniques; and (2) to serve as negative controls for clinical, imaging, and biological variables measured in the patient cohorts. Without data obtained from healthy volunteers, there is no way to determine whether subtle findings in tremor (e.g., physiological tremor) are truly abnormal. The inclusion of healthy volunteers therefore allows to correctly threshold and quantify observed abnormalities. Healthy volunteers may also include non-affected family members of patients with tremor
Key inclusion criteria (13 listed)
- Patients diagnosed with a tremor syndrome, including, but not limited to
- 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.
- Age 18 or older.
Key exclusion criteria (21 listed)
- 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.
- Have abnormal findings of clinical significance on the neurological examination that may affect the scientific integrity of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
methods for tremor phenotyping
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We will share all collected deidentified IPD at the request of others after publication. Data will not be sent until the applicable approvals and data sharing agreement has been obtained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra J Ehrlich, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
methods for tremor phenotyping (time frame: throughout protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.