NCT02618889

OnabotulinumtoxinA in the Management of Psychogenic Dystonia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to evaluate if patients with psychogenic dystonia treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and disability at one month and at three months than those having received placebo injections

Detailed description

Specific Aim 1: To investigate the effect of BoNT on PsyD severity and disability. We will measure the changes in severity, duration, and incapacitation scores of the Rating Scale for Psychogenic Movement Disorders (RSPMD)10 in adult patients with clinically definite PsyD one month after intramuscular injections with onabotulinumtoxinA in selected muscles of the affected limb(s). H1: PsyD patients treated with onabotulinumtoxinA injections will demonstrate lower severity and disability at one month than those having received placebo injections. Specific Aim 2: To investigate the effect of CBT on PsyD severity and disability with and without BoNT pretreatment. We will examine the extent to which any changes in severity and disability of PsyD, as measured by the RSPMD, after 12 weekly CBT sessions, can be influenced by pre-CBT injections with onabotulinumtoxinA.

Conditions

• Torticollis, Dystonia

Interventions

Type	Name	Description
BEHAVIORAL	CBT	All participating subjects will start a 12-week CBT treatment program. These consist of weekly 1-hour CBT sessions led by a cognitive therapist. Assessments will be repeated at week 16. All PsyD subjects will undergo a 15-minute, structured diagnostic interview (Mini International Neuropsychiatric Interview (MINI)) developed to screen for axis I DSM-IV and ICD-10 psychiatric disorders. We will also use two clinician-rated instruments to assess comorbid psychopathology in PsyD patients, the 17-item Hamilton Depression Rating Scale (HAM-D), to evaluate for depressed mood, vegetative and cognitive symptoms of depression; and the 14-item Hamilton Anxiety Rating Scale (HAM-A) to evaluate psychic and somatic anxiety. These scales will be administered as part of a structured interview.

Timeline

• Start date: 2016-01-15
• Primary completion: 2017-05-30
• Completion: 2017-06-30
• First posted: 2015-12-02
• Last updated: 2018-11-30

Locations

1 site across 1 country: United States