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Essential TremorNCT01250067

Motor-related Cortical Potential in Patients With Essential Tremor

A study testing Motor-related cortical potential (Procedure) in people with Essential Tremor and Movement-related Cortical Potentials, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 75 years
What is being tested?
Motor-related cortical potential (Procedure)
Type of treatment
Surgery or procedure
How many people
Not given
Where
1 siteTaiwan
Study dates
Aug 2003to not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • China Medical University Hospital

    Taichung, 40402

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
Motor-related cortical potential (Procedure)
Medical subject headings
Essential Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor-related cortical potential (Procedure)Procedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Nov 2010 (estimated)
  2. Study startAug 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01250067
Sponsor's protocol ID
NSC92-2314-B-039-016
Status last verified
Sep 2005
First submitted
26 Nov 2010
Last updated
30 Nov 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Motor-related cortical potential (Procedure) in people with Essential Tremor and Movement-related Cortical Potentials, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2010.

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