Trial record 8 of 10 for:    Psychogenic Movement

Treatment of Functional Movement Disorders With Psychotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01778517
First received: January 26, 2013
Last updated: September 10, 2014
Last verified: August 2014
  Purpose

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.

Condition Intervention
Movement Disorders
Other: Group Psychotherapy
Other: Cognitive behavior therapy based on self help

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Functional Movement Disorders With Psychotherapy

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Ability to participate in social roles and activities (Neuro-QOL Item Bank) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Somatic symptoms (SCL-90). [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • Self assessment of disease severity (5 point Likert scale). [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Subjective and objective depressive and anxiety symptoms. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Clinical Global impression of severity (CGI). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: December 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Group Psychotherapy
    N/A
    Other: Cognitive behavior therapy based on self help
    N/A
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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 of traumatic brain injury with loss of consciousness or amnesia lasting greater than a few seconds
  • Contraindication to MRI
  • Pregnancy
  • Patients with current post-traumatic stress disorder, panic disorder or obsessive compulsive disorders
  • Patients on tricyclic antidepressants or antiepileptic medications.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778517

Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01778517     History of Changes
Other Study ID Numbers: 130047, 13-N-0047
Study First Received: January 26, 2013
Last Updated: September 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Psychogenic Movement Disorders

Additional relevant MeSH terms:
Conversion Disorder
Disease
Movement Disorders
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Pathologic Processes
Somatoform Disorders

ClinicalTrials.gov processed this record on October 28, 2014