Primary Cervical DystoniaNIDNCT02046447
Neuroimaging of Dystonia
An observational study of Primary Cervical Dystonia and DYT 1 Dystonia, run by University of Florida at 1 site in United States.
Trial summary
The main purpose of this study is to investigate primary cervical dystonia as compared to healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by examining cognitive measures, physical measures, and structural and functional magnetic resonance imaging (MRI). Read more about this study
- Who is it for?
- Ages 7 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Cervical Dystonia, DYT 1 Dystonia
- What is being tested?
- Primary Cervical Dystonia (Trihexyphenidyl) and DYT 1 Dystonia
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Qualifying candidates with a diagnosis of DYT 1 dystonia will be identified and invited to participate utilizing an IRB approved database and neurologists review.
Who may be able to join
- Diagnosis of primary cervical dystonia and between the ages of 18-70, OR
- Diagnosis of DYT 1 dystonia and between the ages of 7-50, OR
- Healthy control and between the ages of 7-70
Who cannot join
- Neurological impairment from: seizure disorders, stroke, hypertension, heart disease, diabetes, traumatic brain injury (TBI), drug abuse, nerve disorders, dementia, Parkinson's Disease, dementia
- Not a candidate for magnetic resonance imaging (MRI)
- Deep brain stimulation (DBS) surgery
- Any implanted electrical device
- Pregnant or planning pregnancy
- Breastfeeding
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuroimaging of Dystonia: The Bachmann-Strauss Dystonia and Parkinson Disease Center of Excellence at the University of Florida
The main purpose of this study is to investigate primary cervical dystonia as compared to healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by examining cognitive measures, physical measures, and structural and functional magnetic resonance imaging (MRI).
The secondary aim of this study is to investigate a specific drug therapy for primary cervical dystonia to develop a functional MRI (fMRI) research paradigm. The drug, trihexyphenidyl, is FDA approved to treat Parkinson's Disease and is commonly prescribed by physicians as a treatment for symptoms of primary cervical dystonia.
Read the detailed description
To participate in this study, you will be asked to come to the University of Florida for one testing day. For your convenience, arrangements will be made by the study coordinator.
If you have a movement disorder, you will be tested in an "off" medication condition. We do not expect concerns or unwanted consequences arising from discontinuing medications for this duration.
We will review the informed consent and you will have the opportunity to ask questions before signing the informed consent. During the experiment, you may be asked to complete the following: (1) questionnaires about quality of life and depression; (2) tests to measure your strength and motor function; (3) tests to measure your cognition; (4) functional and structural MRI scan of your brain while performing a precision gripping task; (5) intravenous blood draw; (6) urine pregnancy test (if applicable); (7) trial of anticholinergic therapy drug trihexyphenidyl (if applicable - cervical dystonia only).
Participants with DYT 1 dystonia and healthy controls are not eligible to receive the trial drug. All women of childbearing potential will be given a urine pregnancy test. The questionnaire about depression will not be given to subjects under the age of 18.
If you have any metal in your eye or eyes, the researchers may require additional screening to ensure that it is safe for you to enter the MRI environment. If additional screening is determined to be necessary, you will be referred to Radiology at Shands UF for an orbitofrontal x-ray.
Blood will be collected for all subjects, including healthy control subjects. The blood may be analyzed, at the University of Florida, to assess potential biomarkers for cervical dystonia and DYT 1 dystonia. Biomarker testing is another way to say genetic testing.
- Conditions
- Primary Cervical Dystonia, DYT 1 Dystonia
- Being tested
- Primary Cervical Dystonia (Trihexyphenidyl), Controls Primary Cervical Dystonia (Trihexyphenidyl), DYT 1 Dystonia (Healthy Control), DYT 1 Dystonia
- Keywords
- dystonia, cervical dystonia, DYT1, DYT 1, DYT-1, Dystonia 1, fMRI, healthy, trihexyphenidyl, Artane, Apo-Trihex, Parkin, Pacitane, Benzhexol, Trihex
- Medical subject headings
- Cervical Dystonia, Primary, Dystonia, Torticollis, Dystonia musculorum deformans type 1, Dystonia Musculorum Deformans
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Cervical Dystonia (Trihexyphenidyl)Drug
Also called Artane, Apo-Trihex, Parkin, Pacitane
After the baseline testing these subjects will receive a dose of trihexyphenidyl 2 mg an hour prior to the second functional magnetic resonance imaging (fMRI) scan. This is to test the change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task after administration of trihexyphenidyl compared to change in BOLD contrast during a precision gripping task. The subjects will be done with the study after the second MRI scan has been completed.
Controls Primary Cervical Dystonia (Trihexyphenidyl)Other
These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed.
DYT 1 Dystonia (Healthy Control)Other
These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed.
DYT 1 DystoniaOther
These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Primary Cervical Dystonia (Trihexyphenidyl) | These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed.
After the above baseline testing these subjects will receive a dose of trihexyphenidyl 2 mg an hour prior to the second functional fMRI scan. The subjects will be done with the study after the second MRI scan has been completed. Receives: Drug: Primary Cervical Dystonia (Trihexyphenidyl) | |
| DYT 1 Dystonia (Healthy Control) | These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed. Receives: Other: DYT 1 Dystonia (Healthy Control) | |
| Primary Cervical Dystonia (Healthy Control) | These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed. Receives: Other: Controls Primary Cervical Dystonia (Trihexyphenidyl) | |
| DYT 1 Dystonia | These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed; and 6) Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) to assess dystonia severity. Receives: Other: DYT 1 Dystonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task
Participants will use their hand to squeeze an MRI compatible grip force transducer in the MRI unit. While producing force, the participants will observe the amount of force generated by viewing a visual feedback display.
Measured: 1 hour
Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task after administration of trihexyphenidyl compared to change in BOLD contrast during a precision gripping task
Subjects with primary cervical dystonia will repeat the primary outcome measure "Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task" one hour after administration of 2mg trihexyphenidyl tablet.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Bachmann Strauss Dystonia & Parkinson Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- David Vaillancourt, PhD, Principal investigator, University of FloridaMichael Okun, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02046447
- Sponsor's protocol ID
- 354-2013
- Acronym
- NID
- Status last verified
- Dec 2017
- First submitted
- 23 Jan 2014
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroimaging of Dystonia: The Bachmann-Strauss Dystonia and Parkinson Disease Center of Excellence at the University of Florida
- ClinicalTrials.gov ID
- NCT02046447
- Acronym / sponsor ID
- NID / 354-2013
- Conditions
- Primary Cervical Dystonia, DYT 1 Dystonia
- Keywords
- dystonia, cervical dystonia, DYT1, DYT 1, DYT-1, Dystonia 1, fMRI, healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Bachmann Strauss Dystonia & Parkinson Foundation, Inc.
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to investigate primary cervical dystonia as compared to healthy control subjects and DYT 1 dystonia as compared to healthy control subjects by examining cognitive measures, physical measures, and structural and functional magnetic resonance imaging (MRI).
The secondary aim of this study is to investigate a specific drug therapy for primary cervical dystonia to develop a functional MRI (fMRI) research paradigm. The drug, trihexyphenidyl, is FDA approved to treat Parkinson's Disease and is commonly prescribed by physicians as a treatment for symptoms of primary cervical dystonia.
Detailed description
To participate in this study, you will be asked to come to the University of Florida for one testing day. For your convenience, arrangements will be made by the study coordinator.
If you have a movement disorder, you will be tested in an "off" medication condition. We do not expect concerns or unwanted consequences arising from discontinuing medications for this duration.
We will review the informed consent and you will have the opportunity to ask questions before signing the informed consent. During the experiment, you may be asked to complete the following: (1) questionnaires about quality of life and depression; (2) tests to measure your strength and motor function; (3) tests to measure your cognition; (4) functional and structural MRI scan of your brain while performing a precision gripping task; (5) intravenous blood draw; (6) urine pregnancy test (if applicable); (7) trial of anticholinergic therapy drug trihexyphenidyl (if applicable - cervical dystonia only).
Participants with DYT 1 dystonia and healthy controls are not eligible to receive the trial drug. All women of childbearing potential will be given a urine pregnancy test. The questionnaire about depression will not be given to subjects under the age of 18.
If you have any metal in your eye or eyes, the researchers may require additional screening to ensure that it is safe for you to enter the MRI environment. If additional screening is determined to be necessary, you will be referred to Radiology at Shands UF for an orbitofrontal x-ray.
Blood will be collected for all subjects, including healthy control subjects. The blood may be analyzed, at the University of Florida, to assess potential biomarkers for cervical dystonia and DYT 1 dystonia. Biomarker testing is another way to say genetic testing.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Primary Cervical Dystonia (Trihexyphenidyl) | – | Drug: Primary Cervical Dystonia (Trihexyphenidyl)These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed. After the above baseline testing these subjects will receive a dose of trihexyphenidyl 2 mg an hour prior to the second functional fMRI scan. The subjects will be done with the study after the second MRI scan has been completed. |
| DYT 1 Dystonia (Healthy Control) | – | Other: DYT 1 Dystonia (Healthy Control)These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed. |
| Primary Cervical Dystonia (Healthy Control) | – | Other: Controls Primary Cervical Dystonia (Trihexyphenidyl)These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed. |
| DYT 1 Dystonia | – | Other: DYT 1 DystoniaThese subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed; and 6) Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) to assess dystonia severity. |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Qualifying candidates with a diagnosis of DYT 1 dystonia will be identified and invited to participate utilizing an IRB approved database and neurologists review.
Key inclusion criteria (3 listed)
- Diagnosis of primary cervical dystonia and between the ages of 18-70, OR
- Diagnosis of DYT 1 dystonia and between the ages of 7-50, OR
- Healthy control and between the ages of 7-70
Key exclusion criteria (7 listed)
- Neurological impairment from: seizure disorders, stroke, hypertension, heart disease, diabetes, traumatic brain injury (TBI), drug abuse, nerve disorders, dementia, Parkinson's Disease, dementia
- Not a candidate for magnetic resonance imaging (MRI)
- Deep brain stimulation (DBS) surgery
- Any implanted electrical device
- Pregnant or planning pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Cervical Dystonia (Trihexyphenidyl)Also: Artane, Apo-Trihex, Parkin, PacitaneAfter the baseline testing these subjects will receive a dose of trihexyphenidyl 2 mg an hour prior to the second functional magnetic resonance imaging (fMRI) scan. This is to test the change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task after administration of trihexyphenidyl compared to change in BOLD contrast during a precision gripping task. The subjects will be done with the study after the second MRI scan has been completed. | Drug | Primary Cervical Dystonia (Trihexyphenidyl) |
| Controls Primary Cervical Dystonia (Trihexyphenidyl)These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed. | Other | Primary Cervical Dystonia (Healthy Control) |
| DYT 1 Dystonia (Healthy Control)These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed. | Other | DYT 1 Dystonia (Healthy Control) |
| DYT 1 DystoniaThese subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed. | Other | DYT 1 Dystonia |
Primary outcome
Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task
Time frame: 1 hour
Participants will use their hand to squeeze an MRI compatible grip force transducer in the MRI unit. While producing force, the participants will observe the amount of force generated by viewing a visual feedback display.
Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task after administration of trihexyphenidyl compared to change in BOLD contrast during a precision gripping task
Time frame: 2 hours
Subjects with primary cervical dystonia will repeat the primary outcome measure "Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task" one hour after administration of 2mg trihexyphenidyl tablet.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Tyler's Hope for a Dystonia CureLink provided by the sponsor.
- UF Center for Movement Disorders \& NeurorestorationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Vaillancourt, PhD principal investigator
University of Florida
Michael Okun, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Cervical Dystonia and DYT 1 Dystonia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.