Ignite Creation Date:
2024-05-06 @ 9:40 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03041714
Status:
COMPLETED
Last Update Posted:
2018-08-01
First Post:
2017-02-02
Brief Title:
Neurophysiologic Study of Patient With Essential Tremor and Dystonic Tremor
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Neurophysiologic Study of Patients With Essential Tremor and Dystonic Tremor
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 17-N-0053 | None | None | None |