OnabotulinumtoxinA in the Management of Psychogenic Dystonia
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/2/2018 |
| Start Date: | January 15, 2016 |
| End Date: | June 30, 2017 |
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
treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and
disability at one month and at three months than those having received placebo injections
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.
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.
Inclusion Criteria:
- Subjects must meet standard criteria for clinically definite PsyD;17
- PsyD severity and disability score ≥ 10 as measured by the RSPMD (Appendix 1);10
- Dystonic posturing must have been present without remission for a period longer than 1
year.
- Between the ages of 18 and 75, inclusive
Exclusion Criteria:
- Prior treatment with any BoNT
- Presence of clinically unstable medical condition other than the condition under
evaluation
- Concurrent participation in another investigational drug or device study within 30
days prior to study enrollment.
- We will also exclude subjects with medical disorders deemed at increased risk when
exposed to BoNT, including myasthenia gravis, Eaton-Lambert syndrome, amyotrophic
lateral sclerosis, or other neuromuscular disorders.
We found this trial at
1
site
Cincinnati, Ohio 45267
Principal Investigator: Alberto J Espay, MD, MSc
Phone: 513-558-4035
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