Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
15 participants
OBSERVATIONAL
2006-04-07
2009-04-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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...
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Psychiatric Correlates of Psychogenic Movement Disorder and Non-Epileptic Seizure
NCT00255411
Neurobiology of Functional Movement Disorder and Non-Epileptic Seizures
NCT00500994
Neurofeedback in Patients With Frontal Brain Lesions
NCT02957695
Brain Activity During Production of Movement
NCT00029939
Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System
NCT00453505
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
To apply respiratory biofeedback to patients with Psychogenic Movement Disorders (PMD) with a goal of decreasing involuntary movements.
Study Population:
Patients diagnosed with "clinically definite" PMD based on the Fahn-Williams scale
Design: Open-label pilot study
Outcome measures:
* To evaluate a possible decrease or resolution in involuntary movements caused by PMD as measured by the Psychogenic Movement Disorder Scale. Videotaping will be performed pre- and post-treatment and the videos will be evaluated by movement disorder specialists who are blinded to the pre-treatment or post-treatment condition.
* To evaluate if respiratory biofeedback is an effective treatment for patients with PMD.
* To retrospectively evaluate the components of anxiety and depression with responders versus non-responders.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients who are at least 18 years old
* Able and willing to cooperate with the study requirements
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Thomas M, Jankovic J. Psychogenic movement disorders: diagnosis and management. CNS Drugs. 2004;18(7):437-52. doi: 10.2165/00023210-200418070-00003.
Factor SA, Podskalny GD, Molho ES. Psychogenic movement disorders: frequency, clinical profile, and characteristics. J Neurol Neurosurg Psychiatry. 1995 Oct;59(4):406-12. doi: 10.1136/jnnp.59.4.406.
Anderson KE. Psychogenic Movement Disorders. Curr Treat Options Neurol. 2003 Mar;5(2):169-176. doi: 10.1007/s11940-003-0007-y.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
06-N-0139
Identifier Type: -
Identifier Source: secondary_id
060139
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.