Overview

This trial is active, not recruiting.

Conditions primary cervical dystonia, dyt 1 dystonia
Treatments primary cervical dystonia (trihexyphenidyl), controls primary cervical dystonia (trihexyphenidyl), dyt 1 dystonia (healthy control), dyt 1 dystonia
Sponsor University of Florida
Collaborator Bachmann Strauss Dystonia & Parkinson Foundation, Inc.
Start date May 2014
End date December 2017
Trial size 60 participants
Trial identifier NCT02046447, 354-2013

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).

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacodynamics study
Intervention model crossover assignment
Masking open label
Primary purpose basic science
Arm
(Experimental)
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.
primary cervical dystonia (trihexyphenidyl) Artane
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.
(Active Comparator)
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)
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.
(Active Comparator)
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.
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.
(Active Comparator)
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.
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; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed.

Primary Outcomes

Measure
Change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task
time frame: 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
time frame: 2 hours

Eligibility Criteria

Male or female participants from 7 years up to 70 years old.

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

Additional Information

Official title Neuroimaging of Dystonia: The Bachmann-Strauss Dystonia and Parkinson Disease Center of Excellence at the University of Florida
Principal investigator David Vaillancourt, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Florida.