Treatment of Functional Movement Disorders With Psychotherapy (NCT01778517) | Clinical Trial Compass
CompletedNot Applicable
Treatment of Functional Movement Disorders With Psychotherapy
United States9 participantsStarted 2012-12-11
Plain-language summary
Background:
\- Functional movement disorder (FMD) is a form of conversion disorder (CD). CD is a disorder in which a person has neurological symptoms that do not have a neurological cause. These symptoms can include pain, weakness, dizziness, and fatigue. Some thoughts on CD suggest that it may come from feelings of anxiety that are converted into physical symptoms. Treatment for FMD usually involves stress reduction, family help, and regular doctor s appointments. Therapy interventions, however, have not been well studied. Researchers want to see if people with FMD get better with psychotherapy. They will study two different types of psychotherapy: group therapy and a self-help manual.
Objectives:
\- To test two different types of therapy treatments for FMD.
Eligibility:
\- Individuals at least 18 years of age who have been diagnosed with FMD by a neurologist.
Design:
* Participants will be screened with a physical exam and medical history. They will also have a psychological exam, and answer questions about their mood and symptoms.
* Participants will be separated into three groups. One group will have group therapy. Another will use a self-help workbook designed for people with FMD, and have individual therapy sessions. A third group will just have standard care. During the study, participants will continue to see their regular doctor.
* Group therapy participants will meet once a week for 6 months at the National Institutes of Health clinical center. There will be 8 to 10 people per group. Sessions will last 75 minutes. These sessions will work on methods for treating FMD.
* Self-help workbook participants will have six individual therapy sessions over 3 to 4 months. They will use the workbooks to learn about and practice methods for treating FMD.
* All participants will be evaluated at 3, 6, and 12 months during the study.
* At the end of the study, participants will have a final follow-up session with exams and questions similar to the screening exam. They will return to the care of their regular doctor.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Must have participated in Protocol 07-N-0190 ( Neurobiological studies of psychogenic movement disorder and non-epileptic seizure )
* Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria. The diagnosis must be made by a neurologist
* Patients who have active movement symptoms at baseline and score at least 20 percent less than the maximum score on the Neuro-QOL Item Bank
* Able to give informed consent
* All participants should be English-speaking
* Age 18 or older
* Willingness to come without reimbursement to treatment visits for up to 6 months
* Willingness to remain on the same medications for the entire duration of the study
EXCLUSION CRITERIA:
* Have significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy
* Patients with psychotic disorders or bipolar disorder
* Patients with history of alcohol and substance use disorders within the last year, as defined by the DSM-IV-TR (nicotine and caffeine use is not criterion for exclusion)
* Current suicidal/homicidal ideation
* Disease severity requiring inpatient treatment. Chronic pain requiring treatment with narcotic medication
ADDITIONAL EXCLUSIONAL CRITERIA 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ability to participate in social roles and activities (Neuro-QOL Item Bank)
Timeframe: 6 months
Trial details
NCT IDNCT01778517
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)