Psychogenic Movement DisordersNCT00255411
Psychiatric Correlates of Psychogenic Movement Disorder and Non-Epileptic Seizure
An observational study of Psychogenic Movement Disorders and Non-epileptic Seizures, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will explore how the mind and the brain work to cause movement symptoms or seizures in people who do not have a recognized neurological or medical disorder. The study includes a check for psychiatric disorders, symptoms and their severity; psychiatric and personality questionnaires; and neuropsychological… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychogenic Movement Disorders, Non-epileptic Seizures
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2005to 24 Feb 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients for dissociation study:
- Diagnosis of clinically definite PMD utilizing Fahn and Williams criteria. The diagnosis will be made by a movement disorders neurologist.
- Or a diagnosis of NES based on video-EEG. The diagnosis will be made by an epileptologist.
- Males or females
- Age 18 or older
- Able to provide informed consent
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- Patients for cognitive study:
- Diagnosis of clinically definite PMD utilizing Fahn and Williams criteria. The diagnosis will be made by a movement disorders neurologist.
- Age 18 or older
- Males or females
- Able to provide informed consent
- Normal volunteers for cognitive study:
- Normal volunteers age 18 or older will be included
- Males or females
- Able to provide informed consent
Who cannot join
- Patients for dissociation study:
- Diagnosis of probable or possible PMD using Fahn and Williams criteria.
- Patients with neurological disorders with elaboration of their underlying disease process including comorbid epilepsy.
- Patients with a medical condition that prevents them from taking part in the study.
- Patients with current suicidal ideation.
- Patients with a psychotic disorder.
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- Patients with active substance abuse within the last 6 months.
- Patients below the age of 18.
- Patients who are not capable of consent.
- Patients with an IQ less than 55.
- Patients currently involved in lawsuits.
- Patients for cognitive study:
- Diagnosis of probable or possible PMD using Fahn and Williams criteria
- Patients with neurological disorders with elaboration of their underlying disease process including comorbid epilepsy
- Patients with a medical condition that prevents them from taking part in the study.
- Patients with a history of a neurological disorder (e.g. dementia, cerebrovascular accident, neurodegenerative disorder, inflammatory disorders or infections of the central nervous system) that may result in cognitive deficits.
- Patients with a history of traumatic brain injury resulting in loss of consciousness or amnesia lasting for more than a few seconds.
- Patients with a psychotic disorder or bipolar disorder
- Patients with a current major depression
- Patients with current moderate to severe anxiety (Hamilton Anxiety Rating Scale greater than 25)
- Patients with current attention deficit hyperactivity disorder.
- Patients with active substance abuse within the last 6 months.
- Patient with current suicidal ideation.
- Patients below the age of 18.
- Patients who are not capable of consent.
- Patients with an IQ less than 55.
- Patients currently involved in lawsuits.
- Normal volunteers for cognitive study:
- Normal volunteers younger than 18 years
- Normal volunteers with an active medical condition that might prevent participation.
- Normal volunteers with a history of neurological disorders (e.g. dementia, cerebrovascular accident, neurodegenerative disorder, inflammatory disorders or infections of the central nervous system) that may result in cognitive deficits
- Normal volunteers with a history of traumatic brain injury resulting in loss of consciousness or amnesia lasting for more than a few seconds
- Normal volunteers with a psychotic disorder or bipolar disorder
- Normal volunteers with a current major depression
- Normal volunteers with moderate to severe anxiety (Hamilton Anxiety Rating Scale greater than 25)
- Normal volunteers with active substance abuse within the last 6 months
- Normal volunteers with current attention deficit hyperactivity disorder
- Normal volunteers with an IQ less than 55
- Normal volunteers who are not capable of consent
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: Neuropsychiatric Correlates of Psychogenic Movement Disorder and Non-Epileptic Seizure
This study will explore how the mind and the brain work to cause movement symptoms or seizures in people who do not have a recognized neurological or medical disorder. The study includes a check for psychiatric disorders, symptoms and their severity; psychiatric and personality questionnaires; and neuropsychological testing.
Normal, healthy volunteers, people who have movement symptoms not due to a brain or medical disorder and people who have seizures not due to epilepsy may be eligible for this study. All candidates must be 18 years of age or older.
Read more
All participants have a medical history, physical examination and psychological evaluation, including completion of questionnaires. People with movement symptoms or seizures have a symptoms evaluation.
Some participants also undergo neuropsychological testing, including questionnaires, pen-and-paper or computerized tests, and motor tasks.
Read the detailed description
Objectives
The objectives of this study are (1) to investigate the relationship between childhood abuse and dissociative experiences in both psychogenic movement disorders (PMD) and non-epileptic seizures (NES) and (2) to investigate the relationship between childhood abuse and both PMD and NES. The secondary objective of the study is to investigate if measures of response inhibition differ between PMD subjects compared to normal controls. This study is part of a larger study investigating the psychological and biological correlates of conversion disorder.
Study population
We intend to study adult patients with diagnoses of PMD seen by the Human Motor Control Section clinic or patients with diagnoses of NES seen by the Epilepsy clinic and normal controls.
Design
A psychiatric assessment, measurement scales and neuropsychological testing will be administered to the PMD and NES patients and normal controls.
Outcome measures
The first primary outcome measure will be the comparison of the different subtypes of childhood abuse (as measured by the Childhood Trauma Interview) and the severity of dissociation (as measured by the Dissociative Experiences Scale). The second primary outcome measure will be the comparison of frequencies of different subtypes of childhood abuse (as measured by the Childhood Trauma Interview) between PMD, NES and normal control groups. The secondary outcome measure will be the comparison of stop-signal reaction time as measured with the stop-signal task.
- Keywords
- Conversion Disorder, Somatoform Disorder, Involuntary Movement, Childhood Abuse, Depression, Psychogenic Movement Disorder, PMD, Non-Epileptic Seizure, NES, Healthy Volunteer, HV
- Medical subject headings
- Seizures, Conversion Disorder, Somatoform Disorders, Dyskinesias, Depression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2005 (estimated)
- Study start9 Nov 2005
- Study completion24 Feb 2009
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 Psychogenic 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
- 190 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255411
- Sponsor's protocol ID
- 060027
- Other IDs
- 06-N-0027
- Status last verified
- 24 Feb 2009
- First submitted
- 17 Nov 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Williams DT, Ford B, Fahn S. Phenomenology and psychopathology related to psychogenic movement disorders. Adv Neurol. 1995;65:231-57. No abstract available.
PubMed 7872143Carson AJ, Ringbauer B, Stone J, McKenzie L, Warlow C, Sharpe M. Do medically unexplained symptoms matter? A prospective cohort study of 300 new referrals to neurology outpatient clinics. J Neurol Neurosurg Psychiatry. 2000 Feb;68(2):207-10. doi: 10.1136/jnnp.68.2.207.
PubMed 10644789Stone J, Carson A, Sharpe M. Functional symptoms and signs in neurology: assessment and diagnosis. J Neurol Neurosurg Psychiatry. 2005 Mar;76 Suppl 1(Suppl 1):i2-12. doi: 10.1136/jnnp.2004.061655. No abstract available.
PubMed 15718217
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
- Neuropsychiatric Correlates of Psychogenic Movement Disorder and Non-Epileptic Seizure
- ClinicalTrials.gov ID
- NCT00255411
- Acronym / sponsor ID
- 060027
- Keywords
- Conversion Disorder, Somatoform Disorder, Involuntary Movement, Childhood Abuse, Depression, Psychogenic Movement Disorder, PMD, Non-Epileptic Seizure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 190 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 Nov 2005
- Study completion
- 24 Feb 2009
- First posted
- 18 Nov 2005 (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 explore how the mind and the brain work to cause movement symptoms or seizures in people who do not have a recognized neurological or medical disorder. The study includes a check for psychiatric disorders, symptoms and their severity; psychiatric and personality questionnaires; and neuropsychological testing.
Normal, healthy volunteers, people who have movement symptoms not due to a brain or medical disorder and people who have seizures not due to epilepsy may be eligible for this study. All candidates must be 18 years of age or older.
All participants have a medical history, physical examination and psychological evaluation, including completion of questionnaires. People with movement symptoms or seizures have a symptoms evaluation.
Some participants also undergo neuropsychological testing, including questionnaires, pen-and-paper or computerized tests, and motor tasks.
Detailed description
Objectives
The objectives of this study are (1) to investigate the relationship between childhood abuse and dissociative experiences in both psychogenic movement disorders (PMD) and non-epileptic seizures (NES) and (2) to investigate the relationship between childhood abuse and both PMD and NES. The secondary objective of the study is to investigate if measures of response inhibition differ between PMD subjects compared to normal controls. This study is part of a larger study investigating the psychological and biological correlates of conversion disorder.
Study population
We intend to study adult patients with diagnoses of PMD seen by the Human Motor Control Section clinic or patients with diagnoses of NES seen by the Epilepsy clinic and normal controls.
Design
A psychiatric assessment, measurement scales and neuropsychological testing will be administered to the PMD and NES patients and normal controls.
Outcome measures
The first primary outcome measure will be the comparison of the different subtypes of childhood abuse (as measured by the Childhood Trauma Interview) and the severity of dissociation (as measured by the Dissociative Experiences Scale). The second primary outcome measure will be the comparison of frequencies of different subtypes of childhood abuse (as measured by the Childhood Trauma Interview) between PMD, NES and normal control groups. The secondary outcome measure will be the comparison of stop-signal reaction time as measured with the stop-signal task.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Diagnosis of clinically definite PMD utilizing Fahn and Williams criteria. The diagnosis will be made by a movement disorders neurologist.
- Or a diagnosis of NES based on video-EEG. The diagnosis will be made by an epileptologist.
- Males or females
- Age 18 or older
- Able to provide informed consent
Key exclusion criteria (39 listed)
- Diagnosis of probable or possible PMD using Fahn and Williams criteria.
- Patients with neurological disorders with elaboration of their underlying disease process including comorbid epilepsy.
- Patients with a medical condition that prevents them from taking part in the study.
- Patients with current suicidal ideation.
- Patients with a psychotic disorder.
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 7872143Williams DT, Ford B, Fahn S. Phenomenology and psychopathology related to psychogenic movement disorders. Adv Neurol. 1995;65:231-57. No abstract available.
- Background: PubMed 10644789Carson AJ, Ringbauer B, Stone J, McKenzie L, Warlow C, Sharpe M. Do medically unexplained symptoms matter? A prospective cohort study of 300 new referrals to neurology outpatient clinics. J Neurol Neurosurg Psychiatry. 2000 Feb;68(2):207-10. doi: 10.1136/jnnp.68.2.207.
- Background: PubMed 15718217Stone J, Carson A, Sharpe M. Functional symptoms and signs in neurology: assessment and diagnosis. J Neurol Neurosurg Psychiatry. 2005 Mar;76 Suppl 1(Suppl 1):i2-12. doi: 10.1136/jnnp.2004.061655. No abstract available.
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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 Psychogenic Movement Disorders and Non-epileptic Seizures, 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 15 inclusion and 39 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 NCT00255411, 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.