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Protocol Details

Neurobiological Studies of Psychogenic Movement Disorders and Non-Epileptic Seizures

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

07-N-0190

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 90

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Conversion Disorder;
Psychogenic Movement Disorders;
Non-Epileptic Seizure;
Functional Magnetic Resonance Imaging (fMRI);
Genetic Polymorphisms

Recruitment Keyword(s)

Psychogenic Movement Disorder;
PMD;
Conversion Disorder;
Non-Epileptic Seizure;
NES;
Healthy Volunteer;
HV

Condition(s)

Psycogenic Movement Disorders;
Non-epileptic seizures

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

This study is part of a series of studies that will explore how the mind and the brain work to cause episodes of uncontrollable shaking in people who have no known underlying brain or medical disorder. The study is conducted at NIH and at the Brown University Rhode Island Hospital.

Healthy volunteers and people with psychogenic movement disorders (PMD) or non-epileptic seizures (NES) who are 18 years of age or older may be eligible for this study.

Patients with NES have 3 teaspoons of blood drawn. The blood is tested for two genes that are normally found in healthy individuals to see if they are found more frequently in patients with uncontrolled shaking.

Patients with PMD have blood drawn for testing and also undergo functional magnetic resonance imaging (fMRI) to look at how the brain functions while the subject performs a specific task. MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. During the scan, the subject lies on a table that can slide in and out of the scanner, a metal cylinder. The scan lasts about 60 to 90 minutes, during which the subject may be asked to lie still for up to 10 minutes at a time and to perform tasks, such as identifying the gender of faces shown on a screen.

Healthy volunteers may have blood drawn for genetic testing or fMRI or both.

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Eligibility

INCLUSION CRITERIA:

General Inclusion Criteria for PMD patients:

-Diagnosis of clinically definite PMD utilizing Fahn and Williams criteria. The diagnosis must be made by a neurologist

-Able to give informed consent

-Age 18 or older

General Inclusion Criteria for Caregivers:

- Age 18 or older

-Able to give informed consent

-Takes care of a patient with PMD patient enrolled in protocol 07-N-0190 for 10 or more weekly hours.

General Inclusion Criteria for PNES patients:

-Diagnosis of PNES based on recording of patient s typical episode during 24 h video-EEG without concomitant EEG changes. The diagnosis must be made by a neurologist.

-Able to give informed consent

-Age 18 or older

General Inclusion Criteria for Healthy Volunteers:

-Able to give informed consent

-Age 18 or older

EXCLUSION CRITERIA:

General exclusion criteria for PMD patients:

-Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy

-Inflammatory disorders or autoimmune disorders active within the last 6 months

-Patients with psychotic disorders or manic depression or active substance abuse within the last 6 months

-Current suicidal ideation

-Disease severity requiring inpatient treatment

Additional exclusion criteria for PMD patients for MRI:

-Patients with movement symptoms at rest that may substantially inhibit resolution, comfort, or safety of MRI

-Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations

-History of traumatic brain injury with loss of consciousness or amnesia lasting greater than a few seconds

-Contraindication to MRI

-Pregnancy

-Significant medical illness

-Patients with current post-traumatic stress disorder

-Patients on tricyclic antidepressants or antiepileptic medications 2 weeks prior to testing

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General exclusion criteria for PNES patients:

-Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy

-Inflammatory disorders or autoimmune disorders active within the last 6 months

-Patients with psychotic disorders or active substance abuse within the last 6 months

-Current suicidal ideation

-Disease severity requiring inpatient treatment

General exclusion criteria for healthy volunteers:

--Significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy

--History of DSM IV-defined schizophrenia, schizoaffective disorder, bipolar disorder or major depression with psychosis

--History of psychotic disorders or manic depression or active substance abuse within the last 6 months

--Subjects with post-traumatic stress disorder

--Subjects on antidepressants or antiepileptic medications

--Inflammatory disorders or autoimmune disorders active within the last 6 months

Additional exclusion criteria for healthy volunteers for MRI:

-Previous history of or MRI findings consistent with brain tumors, strokes, trauma or arterial venous malformations

-Contraindication to MRI

-Pregnancy

-Significant medical illness

General Exclusion Criteria for Caregivers:

-History of DSM-IV defined Schizophrenia, Schizoaffective Disorder, Bipolar Disorder, Major depression with psychotic features (by interview).

-Active substance abuse within the past 6 months (by interview).


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Citations:

Williams DT, Ford B, Fahn S. Phenomenology and psychopathology related to psychogenic movement disorders. Adv Neurol. 1995;65:231-57.

Carson 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;6 (2):207-10.

Feinstein A, Stergiopoulos V, Fine J, Lang AE. Psychiatric outcome in patients with a psychogenic movement disorder: a prospective study. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Jul-Sep;14(3):169-76.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Mark Hallett, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D37
10 CENTER DR
BETHESDA MD 20814
(301) 496-9526
hallettm@ninds.nih.gov

Elaine P. Considine, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D36
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8518
considinee@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00500994

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