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Motor-related Cortical Potential in Patients With Essential Tremor

Primary Purpose

Essential Tremor, Movement-related Cortical Potentials

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Motor-related cortical potential (Procedure)
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Essential Tremor

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • China Medical University Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 26, 2010
Last Updated
November 26, 2010
Sponsor
China Medical University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01250067
Brief Title
Motor-related Cortical Potential in Patients With Essential Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
China Medical University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor, Movement-related Cortical Potentials

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Motor-related cortical potential (Procedure)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chon-Haw Tsai, MD, Ph.D.
Organizational Affiliation
Department of Neurology, China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40402
Country
Taiwan

12. IPD Sharing Statement

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Motor-related Cortical Potential in Patients With Essential Tremor

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