CompletedNot Applicable

Treatment for Psychogenic Disorders

United States15 participantsStarted 2006-04-07

Plain-language summary

This study will examine whether biofeedback treatment is effective in lessening or stopping movement symptoms in people with psychogenic movement disorder. People with this condition have increased or decreased movements that are not under their control and are not associated with any know problem with the nervous system. Biofeedback is a type of therapy that uses electronic instruments to monitor breathing and heart rate. This treatment has been effective in patients with anxiety and panic attacks. People 18 years of age and older diagnosed with psychogenic movement disorder may be eligible for this study. Candidates are screened with a neurological history, physical examination and psychiatric evaluation. Participants come to the NIH Clinical Center for nine 1-hour test sessions over an 8-week period for the following procedures: Week 1 (two visits): * Patients' movements are videotaped while they sit, stand and walk. * Patients train on RESPeRATE device, a computerized musical biofeedback device to help slow theirs breathing rate. The device has three components: a computerized module, earphones, and a chest strap holding a breath sensor. The patients put the elastic strap around their chest, put on the earphones, and sit in a chair. The device monitors and analyzes their breathing to create a melody composed of two distinct tones - one for inhalation and one for exhalation. Patients are instructed to match their breathing to the tones, which gradually slow until they are breathing at a slower, therapeutic rate. * Patients' breathing is monitored and analyzed for information on breathing pattern and rate. * Patients complete questionnaires on level of relaxation before and after RESPeRATE training. * Patients take the RESPeRATE device home to use for two 10-minute practice sessions per day. They complete relaxation questionnaires before and after each session. Weeks 2-7: * Patients' progress is monitored and reviewed from the previous week * Patients' breathing is monitored and analyzed for information on breathing pattern and rate. * Patients complete questionnaires on level of relaxation before and after RESPeRATE training. * Patients are observed for 10 minutes while using the RESPeRATE device. Week 8: * Patients' progress is monitored and reviewed from the previous week * Patients' breathing is monitored and analyzed for information on breathing pattern and rate. * Patients complete questionnaires on level o...

Who can participate

Age range

18 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: * Clinically definite functional (psychogenic) movement disorder as defined by Fahn and Williams criteria diagnosed by a movement disorder neurologist. * Patients who are at least 18 years old * Able and willing to cooperate with the study requirements EXCLUSION CRITERIA: * Any underlying major medical or neurological conditions * Patients whose movements are related to a known neurological disorder * History of traumatic brain injury or history of strokes * Current suicidal ideation * Patients with a psychotic disorder * Patients with active substance abuse within the last 6 months * Patients with moderate to severe depression, Beck Depression Inventory (BDI) greater than 18) * Patients with any ongoing litigation related to their diagnosis of PMD. * Patients with a definite overt stressor identified that is thought to be primarily responsible for the PMD symptoms

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.

Trial details

NCT IDNCT00314444

SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

Sponsor typeNIH

Study typeOBSERVATIONAL

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