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Trial record 83 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

OnabotulinumtoxinA in the Management of Psychogenic Dystonia

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ClinicalTrials.gov Identifier: NCT02618889
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Alberto Espay, University of Cincinnati

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

Condition or disease Intervention/treatment Phase
Torticollis, Dystonia Behavioral: CBT Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: OnabotulinumtoxinA in the Management of Psychogenic Dystonia
Actual Study Start Date : January 15, 2016
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Dystonia

Arm Intervention/treatment
Active Comparator: CBT plus botox
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).
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.

Placebo Comparator: CBT plus placebo
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).
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.




Primary Outcome Measures :
  1. Rating Scale for Psychogenic Movement Disorders (RSPMD) [ Time Frame: 4 months ]
    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 :
  1. Clinical Global Impression (CGI) of change [ Time Frame: 4 months ]
    7-point Likert scale ("very much improved," to "very much worse")

  2. Hamilton Depression Rating Scale (HAM-D) [ Time Frame: 4 months ]
    neuropsychiatric measures of depression.

  3. Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 4 months ]
    neuropsychiatric measures of depression.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02618889


Locations
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United States, Ohio
Alberto Espay
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
University of Cincinnati
Investigators
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Principal Investigator: Alberto Espay, MD University of Cincinnati

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Responsible Party: Alberto Espay, Professor, University of Cincinnati
ClinicalTrials.gov Identifier: NCT02618889     History of Changes
Other Study ID Numbers: 2015-4496
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins, Type A
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents