OnabotulinumtoxinA in the Management of Psychogenic Dystonia

Torticollis, Dystonia Clinical Trial

Official title:

OnabotulinumtoxinA in the Management of Psychogenic Dystonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618889
• Other study ID #: 2015-4496
• Status: Completed
• Phase: Phase 4
• Start date: January 15, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2018
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 30, 2017
• Est. primary completion date: May 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Torticollis
• Torticollis, Dystonia

Intervention

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.

Locations

Country	Name	City	State
United States	Alberto Espay	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating Scale for Psychogenic Movement Disorders (RSPMD)	Primary outcome measures will be the combined severity, duration factor, and incapacitation scores (investigator-rated) of the Rating Scale for Psychogenic Movement Disorders (RSPMD, 0-12 per each limb and head [maximum for all five regions: 60]) (see Appendix 1).	4 months
Secondary	Clinical Global Impression (CGI) of change	7-point Likert scale ("very much improved," to "very much worse")	4 months
Secondary	Hamilton Depression Rating Scale (HAM-D)	neuropsychiatric measures of depression.	4 months
Secondary	Hamilton Anxiety Rating Scale (HAM-A)	neuropsychiatric measures of depression.	4 months