Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic, Women's Studies |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry, Reproductive |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 8/3/2018 |
| Start Date: | April 7, 2017 |
| End Date: | March 22, 2018 |
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.
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.
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.
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.
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.
- INCLUSION CRITERIA
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.
- 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.
EXCLUSION CRITERIA:
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)
- 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.
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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
301-496-2563
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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