Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03027310
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2017-01-18
Brief Title:
Clinical and Physiological Studies of Tremor Syndromes
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Clinical and Physiological Studies of Tremor Syndromes
Status:
COMPLETED
Status Verified Date:
2024-07-30
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
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
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 synchronizationdesynchronization 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
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 synchronizationdesynchronization 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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-0035 | None | None | None |