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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00314444
Other study ID # 060139
Secondary ID 06-N-0139
Status Completed
Phase N/A
First received April 12, 2006
Last updated June 30, 2017
Start date April 7, 2006
Est. completion date April 14, 2009

Study information

Verified date April 14, 2009
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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...


Description:

Objective:

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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date April 14, 2009
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Anderson KE. Psychogenic Movement Disorders. Curr Treat Options Neurol. 2003 Mar;5(2):169-176. — View Citation

Factor SA, Podskalny GD, Molho ES. Psychogenic movement disorders: frequency, clinical profile, and characteristics. J Neurol Neurosurg Psychiatry. 1995 Oct;59(4):406-12. — View Citation

Thomas M, Jankovic J. Psychogenic movement disorders: diagnosis and management. CNS Drugs. 2004;18(7):437-52. Review. — View Citation

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