Neuroimaging of Dystonia

NCT02046447 | Completed DMC

• 1 other identifier: 354-2013
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Cervical Dystonia; DYT 1 Dystonia

Keywords

dystonia; cervical dystonia; DYT1; DYT 1; DYT-1; Dystonia 1; fMRI; healthy; trihexyphenidyl; Artane; Apo-Trihex; Parkin; Pacitane; Benzhexol; Trihex

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 hours

Study Arms (4)

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.

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.

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.

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.

Other: DYT 1 Dystonia

Interventions

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.

Also known as: Artane, Apo-Trihex, Parkin, Pacitane, Benzhexol, Trihex, Trihexphenidyl

Primary Cervical Dystonia (Trihexyphenidyl)

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.

Primary Cervical Dystonia (Healthy Control)

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 (Healthy Control)

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.

DYT 1 Dystonia

Eligibility Criteria

• Age: 7 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Bachmann Strauss Dystonia & Parkinson Foundation, Inc.: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32607, United States

Location

Related Links

• Tyler's Hope for a Dystonia Cure
• UF Center for Movement Disorders \& Neurorestoration

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Cervical Dystonia, Primary; Dystonia; Torticollis; Dystonia musculorum deformans type 1; Dystonia Musculorum Deformans

Interventions

Trihexyphenidyl; Ubiquitin-Protein Ligases; trihex

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Dystonic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ubiquitin-Protein Ligase Complexes; Ligases; Enzymes; Enzymes and Coenzymes

Study Officials

• David Vaillancourt, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Michael Okun, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2014
• First Posted: January 27, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

US (1)