NCT02106819

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

April 3, 2014

Last Update Submit

January 30, 2017

Conditions

Keywords

Cerebellar AtaxiaEmotionsAffective ProsodyFacial ExpressionMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • Florida Affect Battery

    Comprehension of emotional facial and prosodic expressions assessed via identification, discrimination and matching tasks.

    baseline

Secondary Outcomes (3)

  • Perceptual rating of emotional expression

    baseline

  • Intensity and valence ratings of emotionally evocative pictures and words

    baseline

  • Magnetic resonance imaging of the brain

    approximately one week post baseline

Study Arms (2)

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 abilityProcedure: magnetic resonance imaging (MRI) of the brain

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 abilityProcedure: magnetic resonance imaging (MRI) of the brain

Interventions

Assessment of comprehension and expression of emotional facial and prosodic expressions and assessment of emotional reactivity via ratings of emotionally evocative pictures and words.

Cerebellar Ataxia subjectsHealthy Control subjects

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.

Cerebellar Ataxia subjectsHealthy Control subjects

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The ataxia subjects will be recruited from the University of Florida Medical Center. The age matched controls have all been recruited and tested at this point.

You may qualify if:

  • Men and women over the age of 18
  • Individuals with cerebellar ataxia

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, College of Medicine, University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (1)

  • Heilman KM, Leon SA, Burtis DB, Ashizawa T, Subramony SH. Affective communication deficits associated with cerebellar degeneration. Neurocase. 2014;20(1):18-26. doi: 10.1080/13554794.2012.713496. Epub 2012 Sep 28.

    PMID: 23020242BACKGROUND

MeSH Terms

Conditions

Cerebellar DiseasesCerebellar AtaxiaFacial Expression

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesAtaxiaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Kenneth M Heilman, 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

April 3, 2014

First Posted

April 8, 2014

Study Start

April 1, 2014

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations