An observational study in Cervical Dystonia, Movement Disorders and Focal Dystonia, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-07.
Sponsored by Vanderbilt University Medical Center · Observational
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.
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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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 · Diagnostic Test: Assessment of Non-Motor Features
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 · Diagnostic Test: Assessment of Non-Motor Features
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.
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.
Prevalence of spatial discrimination threshold in cervical dystonia patients, unaffected family members, and healthy volunteers
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.
Time frame: Up to 6 months after consent is obtained
Prevalence of temporal discrimination threshold in cervical dystonia patients, unaffected family members, and healthy volunteers
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.
Time frame: Up to 6 months after consent is obtained
Prevalence of vibration-induced illusion of movement in cervical dystonia patients, unaffected family members, and healthy volunteers
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.
Time frame: Up to 6 months after consent is obtained
Prevalence of impaired kinesthesia in cervical dystonia
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.
Time frame: Up to 6 months after consent is obtained
Probability of concurrence of multiple non-motor features
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.
Time frame: Up to 6 months after consent is obtained
Potential new demographic indicators of cervical dystonia
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.
Time frame: Up to 6 months after consent is obtained
Potential new medical indicators of cervical dystonia
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.
Time frame: Up to 6 months after consent is obtained
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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