NCT00314444

Brief 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...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2006

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2006

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2009

Completed
Last Updated

July 2, 2017

Status Verified

April 14, 2009

First QC Date

April 12, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

PsychogenicPsychogenic Movement Disorders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Thomas M, Jankovic J. Psychogenic movement disorders: diagnosis and management. CNS Drugs. 2004;18(7):437-52. doi: 10.2165/00023210-200418070-00003.

    PMID: 15139799BACKGROUND
  • 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.

    PMID: 7561921BACKGROUND
  • Anderson KE. Psychogenic Movement Disorders. Curr Treat Options Neurol. 2003 Mar;5(2):169-176. doi: 10.1007/s11940-003-0007-y.

    PMID: 12628065BACKGROUND

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 12, 2006

First Posted

April 13, 2006

Study Start

April 7, 2006

Study Completion

April 14, 2009

Last Updated

July 2, 2017

Record last verified: 2009-04-14

Locations