NCT01778517

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2015

Completed
Last Updated

July 2, 2017

Status Verified

July 23, 2015

Enrollment Period

2.6 years

First QC Date

January 26, 2013

Last Update Submit

June 30, 2017

Conditions

Movement Disorders

Keywords

Psychogenic Movement Disorders

Outcome Measures

Primary Outcomes (1)

  • Ability to participate in social roles and activities (Neuro-QOL Item Bank)

    6 months

Secondary Outcomes (4)

  • Somatic symptoms (SCL-90).

    at baseline

  • Self assessment of disease severity (5 point Likert scale).

    3 months

  • Subjective and objective depressive and anxiety symptoms.

    6 months

  • Clinical Global impression of severity (CGI).

    12 months

Interventions

Group PsychotherapyOTHER
Cognitive behavior therapy based on self helpOTHER

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Have significant neurological disorders (primary or comorbid) such as neurodegenerative disorders, stroke, movement disorders or epilepsy
  • Patients with psychotic disorders or bipolar disorder
  • Current suicidal/homicidal ideation
  • Disease severity requiring inpatient treatment. Chronic pain requiring treatment with narcotic medication
  • 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.

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)

  • Williams DT, Ford B, Fahn S. Phenomenology and psychopathology related to psychogenic movement disorders. Adv Neurol. 1995;65:231-57. No abstract available.

    PMID: 7872143BACKGROUND

  • Carson AJ, Ringbauer B, Stone J, McKenzie L, Warlow C, Sharpe M. Do medically unexplained symptoms matter? A prospective cohort study of 300 new referrals to neurology outpatient clinics. J Neurol Neurosurg Psychiatry. 2000 Feb;68(2):207-10. doi: 10.1136/jnnp.68.2.207.

    PMID: 10644789BACKGROUND

  • Feinstein A, Stergiopoulos V, Fine J, Lang AE. Psychiatric outcome in patients with a psychogenic movement disorder: a prospective study. Neuropsychiatry Neuropsychol Behav Neurol. 2001 Jul-Sep;14(3):169-76.

    PMID: 11513100BACKGROUND

MeSH Terms

Conditions

Movement Disorders

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Socioenvironmental TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mark Hallett, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2013

First Posted

January 29, 2013

Study Start

December 11, 2012

Primary Completion

July 23, 2015

Study Completion

July 23, 2015

Last Updated

July 2, 2017

Record last verified: 2015-07-23

Locations

US(1)