Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT00500994
Eligibility Criteria:
* INCLUSION CRITERIA:
General Inclusion Criteria for FMD patients:
* Diagnosis of clinically definite FMD 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 FMD 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 FMD 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 FMD 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
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT00500994
Study Brief:
Protocol Section:
NCT00500994