Motor-related Cortical Potential in Patients With Essential Tremor

November 26, 2010 updated by: China Medical University Hospital
In this proposal, in addition to the conventional MRCP recording, the dipoles and sources of the different subcomponents of MRCP will also be analyzed with the brain electric source analysis (BESA) to evaluate the difference in the solutions and source strength underlying the MRCP between normal controls and patients with ET.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Essential tremor (ET) is a common disorder with unknown etiology and pathogenesis. Typically described as a postural tremor, ET often has a marked kinetic component suggesting cerebellar involvement in the pathogenesis of the tremor. The assumption has been illustrated by both positron emission tomography and functional magnetic resonance imaging studies, which revealed that blood flow and activity of the cerebellum were increased in ET patients as compared to the normal controls. In contrast to the cumulative body of imaging evidence, the physiological bases to link the ET and cerebellar functional alternation are scarce. Studies with tandem gait analysis have revealed 25% abnormality of ET patients and surface electromyographic study has found a delay in the second agonist burst during rapid wrist movements suggesting the possible role of cerebellar functional alternation in the generation of ET. In addition, since the tremor of ET tends to appear in the movement ignition or during postural maintenance, it is conceivable that this sort of tremor might exert certain impact on the programming and preparation of the limb movement. Thus it would be appropriate to adopt a tool, which can concomitantly assess the cerebellar function and movement preparation, to investigate the patients with ET. In this proposal, we will record movement-related cortical potentials (MRCP) in ET patients. MRCP is a slow negative shift starting 1-1.5 sec before volitional movement. It consists of at least 3 subcomponents, the Bereitschaftspotential, the negative slope, and the motor potential. The generators crucial for the generation of MRCP include cerebellum, motor and motor association cortex. Thus MRCP seems to be an appropriate tool to assess the patients with ET, in whom the trivial cerebellar functional alternation could be responsible for the tremor generation and motor preparation might be hampered concomitantly. In this proposal, in addition to the conventional MRCP recording, the dipoles and sources of the different subcomponents of MRCP will also be analyzed with the brain electric source analysis (BESA) to evaluate the difference in the solutions and source strength underlying the MRCP between normal controls and patients with ET.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40402
        • China Medical University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bilateral postural tremor with or without kinetic tremor involving hands or forearms, which is visible and persistent, and long-standing in duration (>5 years). Tremor involving body parts other than upper limbs may be present, the tremor may be asymmetrical, amplitude may fluctuate, and the tremor may or may not produce disability.

Exclusion Criteria:

  • Neurological signs, except for Froment's sign
  • Causes of enhanced physiologic tremor
  • Concurrent or recent exposure to tremorgenic drugs
  • Direct or indirect trauma to the central and peripheral nervous system
  • Historical or clinical evidence of psychogenic origins of tremor
  • Convincing evidence of sudden onset or evidence of stepwise deterioration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science Council, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chon-Haw Tsai, MD, Ph.D., Department of Neurology, China Medical University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSC92-2314-B-039-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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