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.
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
- Conditions the study is for
- Essential Tremor, Movement-related Cortical Potentials
- 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.
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.
- First posted30 Nov 2010 (estimated)
- Study startAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Chon-Haw Tsai, MD, Ph.D., Principal investigator, Department of Neurology, China Medical University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor-related Cortical Potential in Patients With Essential Tremor
- ClinicalTrials.gov ID
- NCT01250067
- Acronym / sponsor ID
- NSC92-2314-B-039-016
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2003
- First posted
- 30 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor-related cortical potential (Procedure) | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2010.
Related trials for Essential Tremor
RecruitingObservational study
The Encora X1™ in a Real World Observational Study
Essential Tremor
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Recruiting
Effects of Microelectrode-based Brain Stimulation in Humans
Essential Tremor, Parkinsons Disease (PD)
Active, not recruitingObservational study
Identifying Markers of Disease Subtypes and Disease Progression in the Syndrome of Essential Tremor
Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chon-Haw Tsai, MD, Ph.D. principal investigator
Department of Neurology, China Medical University Hospital
1 site in 1 country: see every site and its status.
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.