Movement DisordersNCT00307346
Physiology of Weakness in Movement Disorders
An observational study of Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will compare electroencephalograph (EEG) recordings in healthy volunteers and in people with movement disorders to examine brain activity associated with the weakness. EEG records the electrical activity of the brain ("brain waves"). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Movement Disorders
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2006to 25 Jan 2011
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both patients and healthy volunteers will be between age 18 and 80.
- Patients will be evaluated in the Human Motor Control Clinic at NINDS.
- The definite diagnosis of the disease may not be completely established at the time of recording.
- Patients have clear and reproducible symptoms of give way weakness of either upper or lower extremities.
- Patients have to be able to resist against the examiner for at least two seconds before giving way.
- Healthy volunteers are right handed adults without history of neurological disease or severe head trauma.
Who cannot join
- Subjects (patients or volunteers) who cannot understand the instructions and consent forms of the protocol will be excluded.
- Subjects who cannot follow the instruction during the entire recording for whatever reason will be excluded.
- Patients with a documented organic central nervous system lesion may be excluded from the study. This will be discussed in detail for each individual subject at the Human Motor Control Clinic.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Physiology of Weakness With Movement Disorders
This study will compare electroencephalograph (EEG) recordings in healthy volunteers and in people with movement disorders to examine brain activity associated with the weakness. EEG records the electrical activity of the brain ("brain waves").
Healthy volunteers and patients with arm or leg weakness who are between 18 and 80 years of age may be eligible for this study. Healthy subjects are screened with a medical history, physical and neurological examinations, and a questionnaire. They must be right-handed and never have had a neurological disease or head trauma.
All participants have an EEG. An elastic cap with electrodes is placed on the subject's scalp to record the brain's electrical activity. During the EEG, subjects are required to resist against a force with their arm, elbow, shoulder or leg for as long as they can. Several recordings are done with short breaks between them.
Read the detailed description
Objective
Give way weakness is a symptom often associated with psychogenic etiology, but its neurophysiological basis is poorly understood. Our objective in this study is to identify the cerebral mechanism of give way weakness.
Study population
We will study 6 patients with give way weakness and 6 healthy volunteers all age 18 years old or older.
Design
In this study, patients will try to resist against the examiner's force and subsequently give way. Electroencephalography (EEG) will be recorded while this maneuver is performed repeatedly.
Outcome measures
Movement-related cortical potential (MRCP) analysis will be performed on the data and its amplitude (in volts) and latency (in seconds) in each individual patient will be described in contrast to the data obtained from healthy volunteers.
- Conditions
- Movement Disorders
- Keywords
- Movement-Related Potential, Electroencephalogram, Psychogenic Movement Disorders, Psychogenic Movement Disorder, Healthy Volunteer, HV
- Medical subject headings
- Movement Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study start23 Mar 2006
- Study completion25 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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
- Observational
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307346
- Sponsor's protocol ID
- 060125
- Other IDs
- 06-N-0125
- Status last verified
- 25 Jan 2011
- First submitted
- 24 Mar 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Terada K, Ikeda A, Nagamine T, Shibasaki H. Movement-related cortical potentials associated with voluntary muscle relaxation. Electroencephalogr Clin Neurophysiol. 1995 Nov;95(5):335-45. doi: 10.1016/0013-4694(95)00098-j.
PubMed 7489662Terada K, Ikeda A, Yazawa S, Nagamine T, Shibasaki H. Movement-related cortical potentials associated with voluntary relaxation of foot muscles. Clin Neurophysiol. 1999 Mar;110(3):397-403. doi: 10.1016/s1388-2457(98)00017-0.
PubMed 10363761Toma K, Honda M, Hanakawa T, Okada T, Fukuyama H, Ikeda A, Nishizawa S, Konishi J, Shibasaki H. Activities of the primary and supplementary motor areas increase in preparation and execution of voluntary muscle relaxation: an event-related fMRI study. J Neurosci. 1999 May 1;19(9):3527-34. doi: 10.1523/JNEUROSCI.19-09-03527.1999.
PubMed 10212312
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiology of Weakness With Movement Disorders
- ClinicalTrials.gov ID
- NCT00307346
- Acronym / sponsor ID
- 060125
- Conditions
- Movement Disorders
- Keywords
- Movement-Related Potential, Electroencephalogram, Psychogenic Movement Disorders, Psychogenic Movement Disorder, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 23 Mar 2006
- Study completion
- 25 Jan 2011
- First posted
- 27 Mar 2006 (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.
This study will compare electroencephalograph (EEG) recordings in healthy volunteers and in people with movement disorders to examine brain activity associated with the weakness. EEG records the electrical activity of the brain ("brain waves").
Healthy volunteers and patients with arm or leg weakness who are between 18 and 80 years of age may be eligible for this study. Healthy subjects are screened with a medical history, physical and neurological examinations, and a questionnaire. They must be right-handed and never have had a neurological disease or head trauma.
All participants have an EEG. An elastic cap with electrodes is placed on the subject's scalp to record the brain's electrical activity. During the EEG, subjects are required to resist against a force with their arm, elbow, shoulder or leg for as long as they can. Several recordings are done with short breaks between them.
Detailed description
Objective
Give way weakness is a symptom often associated with psychogenic etiology, but its neurophysiological basis is poorly understood. Our objective in this study is to identify the cerebral mechanism of give way weakness.
Study population
We will study 6 patients with give way weakness and 6 healthy volunteers all age 18 years old or older.
Design
In this study, patients will try to resist against the examiner's force and subsequently give way. Electroencephalography (EEG) will be recorded while this maneuver is performed repeatedly.
Outcome measures
Movement-related cortical potential (MRCP) analysis will be performed on the data and its amplitude (in volts) and latency (in seconds) in each individual patient will be described in contrast to the data obtained from healthy volunteers.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both patients and healthy volunteers will be between age 18 and 80.
- Patients will be evaluated in the Human Motor Control Clinic at NINDS.
- The definite diagnosis of the disease may not be completely established at the time of recording.
- Patients have clear and reproducible symptoms of give way weakness of either upper or lower extremities.
- Patients have to be able to resist against the examiner for at least two seconds before giving way.
Key exclusion criteria (3 listed)
- Subjects (patients or volunteers) who cannot understand the instructions and consent forms of the protocol will be excluded.
- Subjects who cannot follow the instruction during the entire recording for whatever reason will be excluded.
- Patients with a documented organic central nervous system lesion may be excluded from the study. This will be discussed in detail for each individual subject at the Human Motor Control Clinic.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 2 Jul 2017.
- Background: PubMed 7489662Terada K, Ikeda A, Nagamine T, Shibasaki H. Movement-related cortical potentials associated with voluntary muscle relaxation. Electroencephalogr Clin Neurophysiol. 1995 Nov;95(5):335-45. doi: 10.1016/0013-4694(95)00098-j.
- Background: PubMed 10363761Terada K, Ikeda A, Yazawa S, Nagamine T, Shibasaki H. Movement-related cortical potentials associated with voluntary relaxation of foot muscles. Clin Neurophysiol. 1999 Mar;110(3):397-403. doi: 10.1016/s1388-2457(98)00017-0.
- Background: PubMed 10212312Toma K, Honda M, Hanakawa T, Okada T, Fukuyama H, Ikeda A, Nishizawa S, Konishi J, Shibasaki H. Activities of the primary and supplementary motor areas increase in preparation and execution of voluntary muscle relaxation: an event-related fMRI study. J Neurosci. 1999 May 1;19(9):3527-34. doi: 10.1523/JNEUROSCI.19-09-03527.1999.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Movement Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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 6 inclusion and 3 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 2 Jul 2017. 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 United States. 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?
On the ClinicalTrials.gov record for NCT00307346, which also lists 3 linked publications.
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 2 Jul 2017.