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OnabotulinumtoxinA in the Management of Psychogenic Dystonia

Primary Purpose

Torticollis, Dystonia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CBT
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Torticollis, Dystonia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CBT plus botox

CBT plus placebo

Arm Description

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Clinical Global Impression (CGI) of change
7-point Likert scale ("very much improved," to "very much worse")
Hamilton Depression Rating Scale (HAM-D)
neuropsychiatric measures of depression.
Hamilton Anxiety Rating Scale (HAM-A)
neuropsychiatric measures of depression.

Full Information

First Posted
October 21, 2015
Last Updated
November 28, 2018
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02618889
Brief Title
OnabotulinumtoxinA in the Management of Psychogenic Dystonia
Official Title
OnabotulinumtoxinA in the Management of Psychogenic Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2016 (Actual)
Primary Completion Date
May 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Torticollis, Dystonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT plus botox
Arm Type
Active Comparator
Arm Description
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).
Arm Title
CBT plus placebo
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rating Scale for Psychogenic Movement Disorders (RSPMD)
Description
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).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Clinical Global Impression (CGI) of change
Description
7-point Likert scale ("very much improved," to "very much worse")
Time Frame
4 months
Title
Hamilton Depression Rating Scale (HAM-D)
Description
neuropsychiatric measures of depression.
Time Frame
4 months
Title
Hamilton Anxiety Rating Scale (HAM-A)
Description
neuropsychiatric measures of depression.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alberto Espay, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberto Espay
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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OnabotulinumtoxinA in the Management of Psychogenic Dystonia

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