Clinical trial NCT03471923: Non-Motor Features of Cervical Dystonia (CD)
Official title: Non-Motor Features of Cervical Dystonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dystonia
Movement Disorders
Focal Dystonia
Signs and Symptoms
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Spasmodic Torticollis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-03-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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).

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.

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.

Eligibility 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

Primary outcomes:
measure: Prevalence of spatial discrimination threshold in cervical dystonia patients, unaffected family members, and healthy volunteers
timeFrame: Up to 6 months after consent is obtained
measure: Prevalence of temporal discrimination threshold in cervical dystonia patients, unaffected family members, and healthy volunteers
timeFrame: Up to 6 months after consent is obtained
measure: Prevalence of vibration-induced illusion of movement in cervical dystonia patients, unaffected family members, and healthy volunteers
timeFrame: Up to 6 months after consent is obtained
measure: Prevalence of impaired kinesthesia in cervical dystonia
timeFrame: Up to 6 months after consent is obtained
Secondary outcomes:
measure: Probability of concurrence of multiple non-motor features
timeFrame: Up to 6 months after consent is obtained
Other outcomes:
measure: Potential new demographic indicators of cervical dystonia
timeFrame: Up to 6 months after consent is obtained
measure: Potential new medical indicators of cervical dystonia
timeFrame: Up to 6 months after consent is obtained
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center Clinical Research Center
state: Tennessee
Study officials:
References:
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