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Completed

NCT Number: NCT02046447

Neuroimaging of Dystonia

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.

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Key information

Conditions

Primary Cervical Dystonia Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Cervical Dystonia, Primary Congenital, Hereditary, and Neonatal Diseases and Abnormalities DYT 1 Dystonia Dyskinesias Dystonia Dystonia Musculorum Deformans Dystonia musculorum deformans type 1 Dystonic Disorders Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Torticollis

Age range

7 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32607, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary Cervical Dystonia (Trihexyphenidyl)

Drug

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.

Other names: Artane, Apo-Trihex, Parkin, Pacitane, Benzhexol, Trihex, Trihexphenidyl

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 Dystonia

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Bachmann Strauss Dystonia & Parkinson Foundation, Inc.

Registry information

Official study title

Neuroimaging of Dystonia: The Bachmann-Strauss Dystonia and Parkinson Disease Center of Excellence at the University of Florida

Acronym: NID

Important dates

Study start
2014
Primary completion
2015
Study completion
2017
First posted
Jan 27, 2014
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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