Essential TremorNCT03041714
Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor
An observational study of Essential Tremor and Cervical Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Essential tremor is when a person has tremor, but no other neurological symptoms. Dystonic tremor is when a person also has dystonia. Dystonia is a condition in which muscle contraction causes changes in posture. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor, Cervical Dystonia, Focal Dystonia
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2017to 22 Mar 2018
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be referred to NIH or may refer themselves from all over the United States.
Who may be able to join
- Tremor Subjects:
- Must be 18 years or older
- Fulfill the diagnostic criteria of essential tremor, pure dystonic tremor and tremor associated dystonia, as defined by the Consensus Statement of the Movement Disorder Society on Tremor, 1998. We will recruit patients displaying hand tremors in each group as the follows:
- Hand tremor patients in ET group.
- Dystonic hand tremor patients in pDT group.
- Cervical dystonia (CD) patients or spasmodic dysphonia and hand tremor without clinical evidence of hand dystonia in TAWD group.
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- Ability to give informed consent.
- Ability to comply with all study procedures, based on the judgment by the investigator(s).
- Agree to not drink caffeine or alcohol for 48 hours before participating in the protocol.
- Healthy Volunteers:
- Must be 18 years or older
- Absence of dystonia or other neurological disorder with any effect on the motor or sensory systems.
- Ability to give informed consent.
- Ability to comply with all study procedures, based on the judgment by the investigator(s).
- Agree to not drink caffeine or alcohol for 48 hours before participating in the protocol.
Who cannot join
- Patients:
- Botulinum toxin treatment < 3 months prior to visit.
- Employees and/or staff of NINDS
- Has used illegal drugs within the past 6 months based on history. The intent is to exclude those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled.
- Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.
- Abnormal findings on neurologic exam (other than tremor and dystonia in patient group)
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- Has had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
- Has major depression or any major mental disorders (axis I disorders)
- Has a neurologic disorder other than tremor or dystonia
- Has had a head injury where there was a loss of consciousness for more than a few seconds.
- Currently taking primidone, anticholinergics or benzodiazepines.
- Healthy Volunteers:
- Employees and/or staff of NINDS
- Has used illegal drugs within the past 6 months based on history. The intent is to exclude those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled.
- Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.
- Abnormal findings on neurologic exam.
- Has had a brain tumor, a stroke, head trauma, epilepsy or a history of seizures.
- Has a neurologic disorder other than tremor or dystonia
- Has major depression or any major mental disorders (axis I disorders)
- Has had a head injury where there was a loss of consciousness for more than a few seconds.
- Additional Exclusion Criteria for MRI:
- Has metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, or metal fragments in the eye
- Pregnancy
- Unable to lie flat on the back for the expect length of the study up to 3 hours.
- Feeling uncomfortable being in a small space for up to 3 hours.
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- Additional Exclusion Criteria for TMS:
- Has metal in the body, such as a cardiac pacemaker, brain stimulator, shrapnel, surgical metal, clips in the brain, cochlear implants, or metal fragments in the eye
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Neurophysiologic Study of Patients With Essential Tremor and Dystonic Tremor
Background:
Essential tremor is when a person has tremor, but no other neurological symptoms. Dystonic tremor is when a person also has dystonia. Dystonia is a condition in which muscle contraction causes changes in posture. Researchers do not fully know what areas of the brain cause these tremors, or how the types differ. They also do not know what tests can identify the differences.
Read more
Objective:
To look at differences between essential tremor and dystonic tremor.
Eligibility:
People ages 18 and older with or without tremor
Design:
Participants will be screened with medical history, physical exam, and urine tests. Those with tremor will complete questionnaires about how tremor affects them.
The screening and study visits can be done on the same day or on separate days.
Participants will have 1 or 2 study visits. These include magnetic resonance imaging (MRI) and tremor testing.
For MRI, participants will lie on a table that slides in and out of a cylinder that takes pictures. Sensors on the skin measure breathing, heart rate, and muscle activity. This takes about 2 hours.
Tremor testing will include transcranial magnetic stimulation (TMS), electrical stimulation of the fingers, doing a movement task, and recording of tremor movements. For TMS, two wire coils will be held on the scalp and a brief magnetic field will be produced. A brief electrical current will pass through the coils. For the other tests, small sticky pad electrodes will be put on the skin. Participants will move their hand when they hear a sound. They will get weak electrical shocks to their fingers. These tests will take 3-4 hours.
Participants can take part in either or both parts of the study.
Read the detailed description
Objectives:
To explore a neurophysiological difference between patients with essential tremor (ET) and dystonic tremor (DT).
Sample Size and Population:
We plan to recruit 26 healthy volunteers (HVs), 26 patients with ET, 26 patients with dystonic tremor from the Movement Disorders and Botulinum Toxin (BoNT) clinics of HMCS. The dystonic tremor group will be divided into 2 subgroups: pure dystonic tremor (pDT), patients who have dystonia and tremor in the same limb, tremor associated with dystonia (TAWD), patients who have isolated tremor with dystonia elsewhere. We plan to enroll 13 patients with pDT and 13 with TAWD. We plan to recruit a total of 20 participants including patients with ET, DT and HVs if the use of data from protocol 10-N-0009 is permitted. All neurophysiologic results will be compared between patients and HVs.
Design:
Subjects will come to NIH for at least one study visit. All subjects will undergo a screening visit including taking a medical history and physical examination. Then the patients will be scored clinically for tremor in both ET and DT and dystonia only for DT. All subjects will have a series of transcranial magnetic stimulation (TMS) studies. TMS-induced electromyographic (EMG) activity of hand and forearm muscles will be recorded as motor evoked potentials (MEPs). Pyramidal threshold will be determined by inion stimulation. Then, paired-pulse stimulation at the cerebellum followed by the motor cortex will be performed at rest and at tonic activation of the hand muscle. Only patients will have recordings of tremor at rest, postural holding, and with action and specific tasks such as writing by using accelerometry and EMG. Additionally, a single TMS will be delivered to the motor cortex or cerebellum while the patients elicit their tremor in order to explore the effect of TMS on tremor. All subjects (both HVs and ET, DT) will be tested for their threshold to discriminate somatosensory stimulation and for their performance of quick ballistic movements. All subjects will also undergo a magnetic resonance imaging (MRI) study which includes structural MRI, resting state functional MRI (rsfMRI), diffusion tensor imaging (DTI), MR spectroscopy. The subjects can either undergo the MRI study on the same visit as the other parts of experiment or do it separately.
Outcome measurements:
The various neurophysiological results include the data from the TMS experiment, tremor analysis, threshold of temporal discrimination, ballistic movement and MRI experiment. These results will be compared between HVs and patients group.
- Conditions
- Essential Tremor, Cervical Dystonia, Focal Dystonia
- Keywords
- Essential Tremor, Cervical Dystonia, Hand Dystonia, Neurophysiology, Dystonic Tremor
- Medical subject headings
- Essential Tremor, Torticollis, Dystonic 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 |
|---|---|---|
| Normal volunteers | people who are healthy and without tremor | |
| Essential tremor | Patients with essential tremor | |
| Dystonic tremor | patient with tremor who also have dystonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The various neurophysiological results including the data from TMS experiment, tremor analysis, threshold of temporal discrimination, ballistic movement and MRI experiment. These results will be compared between HVs and patients group.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study start7 Apr 2017
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies 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
- Cross-sectional
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03041714
- Sponsor's protocol ID
- 170053
- Other IDs
- 17-N-0053
- Status last verified
- Mar 2018
- First submitted
- 2 Feb 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
Publications
Deuschl G, Bain P, Brin M. Consensus statement of the Movement Disorder Society on Tremor. Ad Hoc Scientific Committee. Mov Disord. 1998;13 Suppl 3:2-23. doi: 10.1002/mds.870131303.
PubMed 9827589Ni Z, Pinto AD, Lang AE, Chen R. Involvement of the cerebellothalamocortical pathway in Parkinson disease. Ann Neurol. 2010 Dec;68(6):816-24. doi: 10.1002/ana.22221.
PubMed 21194152Pascual-Leone A, Valls-Sole J, Toro C, Wassermann EM, Hallett M. Resetting of essential tremor and postural tremor in Parkinson's disease with transcranial magnetic stimulation. Muscle Nerve. 1994 Jul;17(7):800-7. doi: 10.1002/mus.880170716.
PubMed 8008009
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiologic Study of Patients With Essential Tremor and Dystonic Tremor
- ClinicalTrials.gov ID
- NCT03041714
- Acronym / sponsor ID
- 170053
- Conditions
- Essential Tremor, Cervical Dystonia, Focal Dystonia
- Keywords
- Essential Tremor, Cervical Dystonia, Hand Dystonia, Neurophysiology, Dystonic Tremor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 7 Apr 2017 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 3 Feb 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:
Essential tremor is when a person has tremor, but no other neurological symptoms. Dystonic tremor is when a person also has dystonia. Dystonia is a condition in which muscle contraction causes changes in posture. Researchers do not fully know what areas of the brain cause these tremors, or how the types differ. They also do not know what tests can identify the differences.
Objective:
To look at differences between essential tremor and dystonic tremor.
Eligibility:
People ages 18 and older with or without tremor
Design:
Participants will be screened with medical history, physical exam, and urine tests. Those with tremor will complete questionnaires about how tremor affects them.
The screening and study visits can be done on the same day or on separate days.
Participants will have 1 or 2 study visits. These include magnetic resonance imaging (MRI) and tremor testing.
For MRI, participants will lie on a table that slides in and out of a cylinder that takes pictures. Sensors on the skin measure breathing, heart rate, and muscle activity. This takes about 2 hours.
Tremor testing will include transcranial magnetic stimulation (TMS), electrical stimulation of the fingers, doing a movement task, and recording of tremor movements. For TMS, two wire coils will be held on the scalp and a brief magnetic field will be produced. A brief electrical current will pass through the coils. For the other tests, small sticky pad electrodes will be put on the skin. Participants will move their hand when they hear a sound. They will get weak electrical shocks to their fingers. These tests will take 3-4 hours.
Participants can take part in either or both parts of the study.
Detailed description
Objectives:
To explore a neurophysiological difference between patients with essential tremor (ET) and dystonic tremor (DT).
Sample Size and Population:
We plan to recruit 26 healthy volunteers (HVs), 26 patients with ET, 26 patients with dystonic tremor from the Movement Disorders and Botulinum Toxin (BoNT) clinics of HMCS. The dystonic tremor group will be divided into 2 subgroups: pure dystonic tremor (pDT), patients who have dystonia and tremor in the same limb, tremor associated with dystonia (TAWD), patients who have isolated tremor with dystonia elsewhere. We plan to enroll 13 patients with pDT and 13 with TAWD. We plan to recruit a total of 20 participants including patients with ET, DT and HVs if the use of data from protocol 10-N-0009 is permitted. All neurophysiologic results will be compared between patients and HVs.
Design:
Subjects will come to NIH for at least one study visit. All subjects will undergo a screening visit including taking a medical history and physical examination. Then the patients will be scored clinically for tremor in both ET and DT and dystonia only for DT. All subjects will have a series of transcranial magnetic stimulation (TMS) studies. TMS-induced electromyographic (EMG) activity of hand and forearm muscles will be recorded as motor evoked potentials (MEPs). Pyramidal threshold will be determined by inion stimulation. Then, paired-pulse stimulation at the cerebellum followed by the motor cortex will be performed at rest and at tonic activation of the hand muscle. Only patients will have recordings of tremor at rest, postural holding, and with action and specific tasks such as writing by using accelerometry and EMG. Additionally, a single TMS will be delivered to the motor cortex or cerebellum while the patients elicit their tremor in order to explore the effect of TMS on tremor. All subjects (both HVs and ET, DT) will be tested for their threshold to discriminate somatosensory stimulation and for their performance of quick ballistic movements. All subjects will also undergo a magnetic resonance imaging (MRI) study which includes structural MRI, resting state functional MRI (rsfMRI), diffusion tensor imaging (DTI), MR spectroscopy. The subjects can either undergo the MRI study on the same visit as the other parts of experiment or do it separately.
Outcome measurements:
The various neurophysiological results include the data from the TMS experiment, tremor analysis, threshold of temporal discrimination, ballistic movement and MRI experiment. These results will be compared between HVs and patients group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal volunteers | – | –people who are healthy and without tremor |
| Essential tremor | – | –Patients with essential tremor |
| Dystonic tremor | – | –patient with tremor who also have dystonia |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be referred to NIH or may refer themselves from all over the United States.
Key inclusion criteria (15 listed)
- Must be 18 years or older
- Fulfill the diagnostic criteria of essential tremor, pure dystonic tremor and tremor associated dystonia, as defined by the Consensus Statement of the Movement Disorder Society on Tremor, 1998. We will recruit patients displaying hand tremors in each group as the follows:
- Ability to give informed consent.
- Ability to comply with all study procedures, based on the judgment by the investigator(s).
- Agree to not drink caffeine or alcohol for 48 hours before participating in the protocol.
Key exclusion criteria (29 listed)
- Botulinum toxin treatment < 3 months prior to visit.
- Employees and/or staff of NINDS
- Has used illegal drugs within the past 6 months based on history. The intent is to exclude those with drug use that may affect study results. Participants who appear to be intoxicated at the time of testing will be rescheduled.
- Has more than 7 alcoholic drinks a week in the case of a woman and 14 alcoholic drinks a week in the case of a man.
- Abnormal findings on neurologic exam (other than tremor and dystonia in patient group)
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
The various neurophysiological results including the data from TMS experiment, tremor analysis, threshold of temporal discrimination, ballistic movement and MRI experiment. These results will be compared between HVs and patients group.
Time frame: 2 years
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 1 Aug 2018.
- Background: PubMed 9827589Deuschl G, Bain P, Brin M. Consensus statement of the Movement Disorder Society on Tremor. Ad Hoc Scientific Committee. Mov Disord. 1998;13 Suppl 3:2-23. doi: 10.1002/mds.870131303.
- Background: PubMed 21194152Ni Z, Pinto AD, Lang AE, Chen R. Involvement of the cerebellothalamocortical pathway in Parkinson disease. Ann Neurol. 2010 Dec;68(6):816-24. doi: 10.1002/ana.22221.
- Background: PubMed 8008009Pascual-Leone A, Valls-Sole J, Toro C, Wassermann EM, Hallett M. Resetting of essential tremor and postural tremor in Parkinson's disease with transcranial magnetic stimulation. Muscle Nerve. 1994 Jul;17(7):800-7. doi: 10.1002/mus.880170716.
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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.
Mark Hallett, 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 Essential Tremor and Cervical 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 15 inclusion and 29 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 1 Aug 2018. 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?
The various neurophysiological results including the data from TMS experiment, tremor analysis, threshold of temporal discrimination, ballistic movement and MRI experiment. These results will be compared between HVs and patients group. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03041714, which also lists 3 linked publications.
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 1 Aug 2018.