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Clinical Trial 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


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02618889
Study type Interventional
Source University of Cincinnati
Contact
Status Completed
Phase Phase 4
Start date January 15, 2016
Completion date June 30, 2017