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Trial record 53 of 116 for:    cervical | "dopa-responsive dystonia" OR "Dystonia"

Non-Motor Features of Cervical Dystonia (CD)

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ClinicalTrials.gov Identifier: NCT03471923
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
Vanderbilt Institute for Clinical and Translational Research
Information provided by (Responsible Party):
Mallory Hacker, Vanderbilt University Medical Center

Brief Summary:
This study will examine the prevalence of four previously identified non-motor markers in a population of cervical dystonia patients, unaffected family members, and healthy volunteers in an attempt to identify a distinct combination of non-motor symptoms that may be indicative of disease development.

Condition or disease Intervention/treatment
Cervical Dystonia Movement Disorders Focal Dystonia Signs and Symptoms Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Spasmodic Torticollis Diagnostic Test: Neurological Examination Diagnostic Test: Assessment of Non-Motor Features

Detailed Description:

The primary aim of this study is to identify the prevalence of four previously identified non-motor markers - (1) spatial discrimination threshold, (2) temporal discrimination threshold, (3) vibration-induced illusion of movement, and (4) kinesthesia - in a population of cervical dystonia patients, unaffected family members, and healthy volunteers (control group). Consenting participants will receive a neurological examination performed by a movement disorders neurologist, followed by an assessment of the four non-motor symptoms.

The investigators hypothesize that a distinct combination of non-motor symptoms will be more prevalent in the CD group, and therefore this set of symptoms may be indicative of disease development. This combination will be identified through analysis of the concurrence of the non-motor features across the three groups of participants. This study will fill an important unmet need, as to the investigators' knowledge there are no published studies assessing the comorbid presentation of these four non-motor symptoms in a single cervical dystonia population. The exploration of a distinct combination of concurrent non-motor symptoms as a marker for the development of cervical dystonia will improve the ability of movement disorders neurologists to diagnose the condition.

The results of this study will facilitate the investigators' longstanding aim of improving rates of cervical dystonia diagnosis. Cervical dystonia is currently diagnosed based upon the exclusion of other movement disorders; therefore, characterization of non-motor features in cervical dystonia patients will help to refine the diagnostic criteria for this condition. This investigation will also improve understanding of the factors associated with CD. Future studies can examine the source of these associated factors in order to help understand the cause of CD, since the etiology is currently unknown.


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Study Type : Observational
Estimated Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Non-Motor Features of Cervical Dystonia
Actual Study Start Date : March 26, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019


Group/Cohort Intervention/treatment
CD Patients
Subjects must have a prior diagnosis of cervical dystonia and be capable of participating in all study procedures. Subjects will undergo assessment of non-motor features.
Diagnostic Test: Assessment of Non-Motor Features
All subjects will be assessed for four non-motor symptoms, including (1) spatial discrimination threshold, (2) temporal discrimination threshold, (3) vibration-induced illusion of movement, and (4) kinesthesia.

Family Members
Subjects must be a first order relation of a Vanderbilt patient diagnosed with cervical dystonia. The subject must pass a short neurological examination to ensure the subject does not have cervical dystonia or any sensory deficits. Subjects will undergo assessment of non-motor features.
Diagnostic Test: Neurological Examination
The family members and healthy volunteers will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of cervical dystonia and other sensory abnormalities. If the subject is found to have cervical dystonia or any other sensory abnormalities, the subject will be excluded from the study.

Diagnostic Test: Assessment of Non-Motor Features
All subjects will be assessed for four non-motor symptoms, including (1) spatial discrimination threshold, (2) temporal discrimination threshold, (3) vibration-induced illusion of movement, and (4) kinesthesia.

Healthy volunteers
Subjects must be healthy volunteers who are neurologically normal. The subject must pass a short neurological examination to ensure the subject does not have cervical dystonia or any sensory deficits. Subjects will undergo assessment of non-motor features.
Diagnostic Test: Neurological Examination
The family members and healthy volunteers will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of cervical dystonia and other sensory abnormalities. If the subject is found to have cervical dystonia or any other sensory abnormalities, the subject will be excluded from the study.

Diagnostic Test: Assessment of Non-Motor Features
All subjects will be assessed for four non-motor symptoms, including (1) spatial discrimination threshold, (2) temporal discrimination threshold, (3) vibration-induced illusion of movement, and (4) kinesthesia.




Primary Outcome Measures :
  1. Prevalence of spatial discrimination threshold in cervical dystonia patients, unaffected family members, and healthy volunteers [ Time Frame: Up to 6 months after consent is obtained ]
    For participants in all groups, the investigators will examine the prevalence of spatial discrimination threshold. Prevalence of spatial discrimination threshold will be determined with a task using Johnson-Van-Boven-Phillips (JVP) domes. The spatial discrimination threshold will be recorded as the mean of both hands at the 75% level of accuracy. The research coordinator will report prevalence of spatial discrimination threshold as a descriptive statistic.

  2. Prevalence of temporal discrimination threshold in cervical dystonia patients, unaffected family members, and healthy volunteers [ Time Frame: Up to 6 months after consent is obtained ]
    For participants in all groups, the investigators will examine the prevalence of temporal discrimination threshold. Prevalence of temporal discrimination threshold will be determined with a visual-visual discrimination task.The research coordinator will report prevalence of temporal discrimination threshold as a descriptive statistic.

  3. Prevalence of vibration-induced illusion of movement in cervical dystonia patients, unaffected family members, and healthy volunteers [ Time Frame: Up to 6 months after consent is obtained ]
    For participants in all groups, the investigators will examine the prevalence of vibration-induced illusion of movement. Prevalence of vibration-induced illusion of movement will be determined by recording the change in displacement of the tracking arm during a vibration-induced illusion of movement task. The research coordinator will report prevalence of vibration-induced illusion of movement as a descriptive statistic.

  4. Prevalence of impaired kinesthesia in cervical dystonia [ Time Frame: Up to 6 months after consent is obtained ]
    For participants in all groups, the investigators will examine the prevalence of impaired kinesthesia. Kinesthesia will be determined by a neurologist during the neurological examination. The research coordinator will report prevalence of impaired kinesthesia as a descriptive statistic.


Secondary Outcome Measures :
  1. Probability of concurrence of multiple non-motor features [ Time Frame: Up to 6 months after consent is obtained ]
    The concurrence of multiple non-motor symptoms will be assessed using a multinomial logistic regression model to determine if a distinct combination of non-motor symptoms is more prevalent in the cervical dystonia patient group than in the unaffected family members or healthy volunteer groups.


Other Outcome Measures:
  1. Potential new demographic indicators of cervical dystonia [ Time Frame: Up to 6 months after consent is obtained ]
    Analysis of demographic factors will be performed to identify additional environmental factors that are more prevalent in the CD patient population than in healthy controls and unaffected family members. Through exploration of potential new indicators, the investigators hope to progress the long-term goal of improving the rate of cervical dystonia diagnosis.

  2. Potential new medical indicators of cervical dystonia [ Time Frame: Up to 6 months after consent is obtained ]
    Analysis of medical history and specific elements of the neurological examination will be performed to identify additional symptoms and environmental factors that are more prevalent in the CD patient population than in healthy controls and unaffected family members. Emphasis will be placed on sensory tricks, as previous studies and clinical experience have shown that patients often use sensory tricks such as touching the face, hand, or neck to temporarily relieve muscle contraction. Through exploration of potential new indicators, the investigators hope to progress the long-term goal of improving the rate of cervical dystonia diagnosis.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Participants in this study will include adults that have cervical dystonia, are healthy and related to someone with cervical dystonia, or are healthy and not related to someone with cervical dystonia (control group).
Criteria

Inclusion Criteria:

  • Have a diagnosis of cervical dystonia, OR a first order relation of a Vanderbilt patient diagnosed with cervical dystonia, OR a healthy volunteer who is neurologically normal
  • Capable of participating in all study procedures
  • Willing and able to provide written or verbal informed consent.

Exclusion Criteria:

  • Subjects for whom participation in the study may cause medical harm
  • Subjects who are not considered competent to make their own medical decisions
  • Subjects who display sensory deficits during a short screening examination prior to study enrollment

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): NCT03471923


Contacts
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Contact: Mallory Hacker, Ph.D. 615-875-7437 mallory.hacker@vanderbilt.edu
Contact: David Charles, M.D. 615-322-2538 david.charles@vanderbilt.edu

Locations
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United States, Tennessee
Vanderbilt University Medical Center Clinical Research Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Bryan Eoff         
Principal Investigator: Mallory L Hacker, PhD         
Sponsors and Collaborators
Vanderbilt University Medical Center
Vanderbilt Institute for Clinical and Translational Research

Publications:
Westenberger A, Klein C. Genetics of dystonia. In: Dystonia and Dystonic Syndromes. ; 2015:27-48. doi:10.1007/978-3-7091-1516-9_3.
Klingelhoefer L, Martino D, Martinez-Martin P, et al. Nonmotor symptoms and focal cervical dystonia: Observations from 102 patients. Basal Ganglia. 2014;4(3-4):117-120. doi:10.1016/j.baga.2014.10.002.

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Responsible Party: Mallory Hacker, Research Instructor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03471923     History of Changes
Other Study ID Numbers: 171717
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Torticollis
Neurologic Manifestations
Neuromuscular Manifestations
Dyskinesias
Central Nervous System Diseases