OnabotulinumtoxinA in the Management of Psychogenic Dystonia
Torticollis, Dystonia
About this trial
This is an interventional treatment trial for Torticollis, Dystonia
Eligibility Criteria
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.
Sites / Locations
- Alberto Espay
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
CBT plus botox
CBT plus placebo
Participants will be randomized to receive BoNT (onabotulinumtoxinA). Patients will undergo study assessments four weeks later. We will inject a total of 250 units of onabotulinumtoxinA, as the average optimal dose in cervical dystonia,11 using a 100:1 dilution with normal saline. The target muscles will be the ones deemed most active in the cervical region or in any of the affected limbs. If several limbs are affected, only up to two will be targeted in similar fashion, with a total dose not to exceed 400 units altogether (250 +150 units, if involvement is asymmetric or unilateral [leg and arm, respectively]; 200 + 200 units, if involvement is symmetric).
Participants will be randomized to receive normal saline (placebo). We will inject a total of 250 units of normal saline, as this is the average optimal dose of onabotulinumtoxinA in cervical dystonia. The target muscles will be the ones deemed most active in the cervical region or in any of the affected limbs. If several limbs are affected, only up to two will be targeted in similar fashion, with a total dose not to exceed 400 units altogether (250 +150 units, if involvement is asymmetric or unilateral [leg and arm, respectively]; 200 + 200 units, if involvement is symmetric).