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Trial record 5 of 77 for:    Cerebellar Degeneration

Emotional Communication Disorders in Cerebellar Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02106819
First received: April 3, 2014
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

The cerebellum has been linked to cognitive and emotional functions and there is increasing evidence that damage to posterior portions of the cerebellum can result in frontal-executive, visuospatial, and verbal deficits, including dysprosodia, and affective changes including blunting of affect or disinhibited and inappropriate behavior. Based on preliminary clinical observations and tests performed in the investigator's clinic, disorders of emotional communication may also be associated with cerebellar dysfunction. Emotional communication includes the production and comprehension of facial and prosodic expressions and is critical to maintaining positive and supportive relationships. Deficits in emotional communication can have devastating effects on relationships and on quality of life for those affected. Although deficits in affect and prosody have been reported in association with posterior cerebellar disorders, there are currently no studies systematically investigating emotional communication in individuals with cerebellar dysfunction. It is known that the cerebellum has strong connections with the cerebral cortex, especially the frontal lobes, and that cortical damage from stroke or neurodegenerative disease can result in disorders of emotional communication. Impairments in the integrity of cerebellar-cerebral networks from cerebellar disease may produce similar deficits in emotional communication. The purpose of this study is to systematically investigate and describe deficits in emotional communication in a series of patients with cerebellar disease. Participants will be individuals diagnosed with posterior cerebellar degeneration or damage from a non-hemorrhagic infarction, and age-matched neurologically healthy controls. Assessment will include a battery of tests of neuropsychological function as well as tests of emotional communication. Comprehension of emotional facial and prosodic expressions will be assessed as well as production of emotional communication. The expected outcomes will be to identify and describe deficits in production and comprehension of emotional prosodic and facial expressions and to describe the relationship between deficits in emotional communication and cerebellar atrophy with magnetic resonance imaging imaging (MRI) using voxel based morphometry (VBM).


Condition Intervention
Cerebellar Diseases
Behavioral: Testing of emotional communication ability
Procedure: magnetic resonance imaging (MRI) of the brain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Disorders of Emotional Communication in Patient With Cerebellar Dysfunction

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Florida Affect Battery [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Comprehension of emotional facial and prosodic expressions assessed via identification, discrimination and matching tasks.


Secondary Outcome Measures:
  • Perceptual rating of emotional expression [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Ability to express emotions by alterations of facial postures and changes in vocal prosody will be assessed imitatively and to-command. The expressions will be recorded and independently rated by three trained judges who will rate the type of facial or prosodic expression and the intensity (0-4).

  • Intensity and valence ratings of emotionally evocative pictures and words [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Comparison of participant ratings of valence and emotional intensity of words and pictures using items from a database of stimuli with normative ratings for emotional valence and arousal/intensity.

  • Magnetic resonance imaging of the brain [ Time Frame: approximately one week post baseline ] [ Designated as safety issue: No ]
    Neuroimaging data collection will be done using a Philips Achieva 3T scanner (Amsterdam, Netherlands) and a 32-channel SENSE head coil. Imaging collected will include anatomical T1-weighted imaging scans.


Estimated Enrollment: 80
Study Start Date: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cerebellar Ataxia subjects
40 individuals with either hereditary or sporadic ataxia will have testing of emotional communication ability and may have magnetic resonance imaging (MRI) of the brain.
Behavioral: Testing of emotional communication ability
Asssessment of comprehension and expression of emotional facial and prosodic expressions and assesment of emotional reactivity via ratings of emotionally evocative pictures and words.
Procedure: magnetic resonance imaging (MRI) of the brain
Cerebellar participants who score at least 1 and a 1/2 standard deviations below the mean on the Florida Affect Battery and who have no contra-indications to scanning will be given an MRI. Healthy control participants who are willing and able to be scanned will also be given an MRI of the brain to use for analysis comparison.
Healthy Control subjects
40 age matched controls will have testing of emotional communication ability and may have magnetic resonance imaging (MRI) of the brain.
Behavioral: Testing of emotional communication ability
Asssessment of comprehension and expression of emotional facial and prosodic expressions and assesment of emotional reactivity via ratings of emotionally evocative pictures and words.
Procedure: magnetic resonance imaging (MRI) of the brain
Cerebellar participants who score at least 1 and a 1/2 standard deviations below the mean on the Florida Affect Battery and who have no contra-indications to scanning will be given an MRI. Healthy control participants who are willing and able to be scanned will also be given an MRI of the brain to use for analysis comparison.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The ataxia subjects will be recruited from the University of Florida Medical Center. The age matched controls will be recruited from the local community.

Criteria

Inclusion Criteria:

  • Men and women over the age of 18
  • Individuals with either cerebellar ataxia or healthy control subjects with no neurological disease

Exclusion Criteria:

  • Neurological signs reflecting major pathology in extrapyramidal, brainstem, cortical and visual systems
  • Symptomatic cerebellar ataxia from alcohol, toxins, vitamin deficiency, and paraneoplastic cerebellar degeneration
  • Dementia
  • Current symptoms of depression or severe anxiety
  • Currently on any psychotropic medication other than anti-depressants or history of a psychosis
  • Severe impairments of hearing or vision
  • Reading level less than 10th grade and/or history of learning disability
  • Chronic medical and neurological diseases other than cerebellar (e.g., cardiac failure, renal disease, hepatic failure, stroke)
  • History of severe head trauma (e.g., coma for more than one hour)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02106819

Contacts
Contact: Susan A Leon, PhD 352-376-1611 ext 5059 susan.leon@neurology.ufl.edu

Locations
United States, Florida
Department of Neurology, College of Medicine, University of Florida Recruiting
Gainesville, Florida, United States, 32610
Principal Investigator: Kenneth M Heilman, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Kenneth M Heilman, MD University of Florida
  More Information

Publications:
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02106819     History of Changes
Other Study ID Numbers: 201300595, 1R21AG044449-01A1
Study First Received: April 3, 2014
Last Updated: October 30, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Florida:
Cerebellar Ataxia
Emotions
Affective Prosody
Facial Expression
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Cerebellar Diseases
Communication Disorders
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014