Cerebellar DiseasesNCT02106819
Emotional Communication Disorders in Cerebellar Disease
An observational study of Cerebellar Diseases, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cerebellar Diseases
- What is being tested?
- Testing of emotional communication ability and magnetic resonance imaging (MRI) of the brain
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Men and women over the age of 18
- Individuals with cerebellar ataxia
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Neurology, College of Medicine, University of Florida
Gainesville, Florida, 32610
About this study
Official title: Disorders of Emotional Communication in Patient With Cerebellar Dysfunction
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).
Read the detailed description
The specific aims of this proposal will investigate the hypothesis that cerebellar damage is associated with emotional communication deficits.
- Determine whether posterior cerebellar damage results in deficits in the production or comprehension of emotional facial expressions and/or vocal prosodic expressions
- Determine whether posterior cerebellar damage results in alterations in intensity of reaction to emotionally evocative pictures or emotionally evocative words
- Investigate the relationship between performance on tests of emotional communication and left versus right cerebellar atrophy with magnetic resonance imaging imaging (MRI) using voxel based morphometry (VBM) analysis
All subjects (cerebellar and control) will be given the following testing in a single session of lasting 3 to 3 and a half hours. Included will be tests to assess reading ability, naming ability, several tests of memory, a test of ability to discriminate between faces, tests of mental flexibility, and standardized questionnaires for depression, anxiety and emotional empathy. The tests include:
- Wechsler Test of Adult Reading
- Montreal Cognitive Assessment
- Beck Depression Inventory - 2
- Wisconsin Card Sorting test
- Toronto Alexithymia Scale
- Multi-Dimensional Emotional Empathy Scale
All subjects will also be given tests assessing emotional communication ability. Tests of recognition and expression of emotional tones of voice and facial expression will be performed. Expression of facial expressions and tones of voice will be video recorded so that blinded raters can compare the accuracy and intensity of facial expressions and tones of voice between the participants. Training for the raters will include familiarization with the descriptions of features for each emotion with respect to changes in pitch, loudness, and rate for prosody and changes in facial features for facial expression. Both intra- and inter-judge reliability will be calculated for these blinded judges. To supplement this perceptual analysis, the participant's responses will be recorded using VisiPitch IV software, a clinical instrument that performs sound analyses and calculates the variation in the range of fundamental frequency (i.e., pitch variation) across each sentence. The ability to manipulate pitch to produce varying prosodic contours is the most salient acoustical feature of affective prosody.
We will also assess intensity ratings and descriptions of emotional pictures and words using materials that have established rating norms. Participants will be shown a series of pictures and asked to rate the emotional intensity of the picture. They will also be asked to give a brief description of the picture. They will then be given a list of words, one at a time, and asked to rate the emotional intensity of these words.
Some of the cerebellar participants will also be asked to participate in a magnetic resonance imaging (MRI) scan of the brain if the testing listed above shows deficits in understanding or producing emotional facial expressions or tones of voice and if there are no reasons that would prevent them from being able to enter a scanner (determined by a standard MRI screen form). Healthy control participants may also be asked to participate in a magnetic resonance imaging (MRI) scan of the brain and if there are no reasons that would prevent them from being able to enter a scanner. The imaging data will be used to investigate if there is a relationship between our experimental subjects' performance on tests of emotional expression and left versus right cerebellar atrophy-injury in the cerebellar lobules with MRI imaging using a voxel based morphometry (VBM) approach. The same data from controls will be used for comparison. 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. Structural MP-RAGE T1-weighted scans will be acquired with 130-1.0 mm sagittal slices, FOV=240 mm (AP)-180 mm (FH), matrix= 256-192, TR= 9.90 ms, TE= 4.60 ms, Flip Angle= 8, voxel size= 1.0x 0.94x 0.94 mm. Structural data will be analyzed with FSL-VBM, an optimized VBM protocol carried out with FSL tools. First, structural images will be brain-extracted and grey matter-segmented before being registered to the MNI 152 standard space using non-linear registration The resulting images will be averaged and flipped along the x-axis to create a left-right symmetric, study-specific grey matter template. Second, all native grey matter images will be non-linearly registered to this study-specific template and "modulated" to correct for local expansion (or contraction) due to the non-linear component of the spatial transformation. The modulated grey matter images were then smoothed with an isotropic Gaussian kernel with a sigma of 6 mm. Finally, voxelwise GLM will be applied using permutation-based non-parametric testing, correcting for multiple comparisons across space.
- Conditions
- Cerebellar Diseases
- Being tested
- Testing of emotional communication ability, magnetic resonance imaging (MRI) of the brain
- Keywords
- Cerebellar Ataxia, Emotions, Affective Prosody, Facial Expression, Magnetic Resonance Imaging
- Medical subject headings
- Cerebellar Diseases, Cerebellar Ataxia, Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing of emotional communication abilityBehavioural
Assessment of comprehension and expression of emotional facial and prosodic expressions and assessment of emotional reactivity via ratings of emotionally evocative pictures and words.
magnetic resonance imaging (MRI) of the brainProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Testing of emotional communication ability; Procedure: 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. Receives: Behavioral: Testing of emotional communication ability; Procedure: magnetic resonance imaging (MRI) of the brain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Florida Affect Battery
Comprehension of emotional facial and prosodic expressions assessed via identification, discrimination and matching tasks.
Measured: baseline
Secondary outcomes (3)
Perceptual rating of emotional expression
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).
Measured: baseline
Intensity and valence ratings of emotionally evocative pictures and words
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.
Measured: baseline
Magnetic resonance imaging of the brain
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.
Measured: approximately one week post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startApr 2014
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebellar DiseasesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Kenneth M Heilman, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106819
- Sponsor's protocol ID
- IRB201300595
- Other IDs
- 1R21AG044449-01A1
- Status last verified
- Jan 2017
- First submitted
- 3 Apr 2014
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23020242
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disorders of Emotional Communication in Patient With Cerebellar Dysfunction
- ClinicalTrials.gov ID
- NCT02106819
- Acronym / sponsor ID
- IRB201300595
- Conditions
- Cerebellar Diseases
- Keywords
- Cerebellar Ataxia, Emotions, Affective Prosody, Facial Expression, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Apr 2014
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The specific aims of this proposal will investigate the hypothesis that cerebellar damage is associated with emotional communication deficits.
- Determine whether posterior cerebellar damage results in deficits in the production or comprehension of emotional facial expressions and/or vocal prosodic expressions
- Determine whether posterior cerebellar damage results in alterations in intensity of reaction to emotionally evocative pictures or emotionally evocative words
- Investigate the relationship between performance on tests of emotional communication and left versus right cerebellar atrophy with magnetic resonance imaging imaging (MRI) using voxel based morphometry (VBM) analysis
All subjects (cerebellar and control) will be given the following testing in a single session of lasting 3 to 3 and a half hours. Included will be tests to assess reading ability, naming ability, several tests of memory, a test of ability to discriminate between faces, tests of mental flexibility, and standardized questionnaires for depression, anxiety and emotional empathy. The tests include:
- Wechsler Test of Adult Reading
- Montreal Cognitive Assessment
- Beck Depression Inventory - 2
- Wisconsin Card Sorting test
- Toronto Alexithymia Scale
- Multi-Dimensional Emotional Empathy Scale
All subjects will also be given tests assessing emotional communication ability. Tests of recognition and expression of emotional tones of voice and facial expression will be performed. Expression of facial expressions and tones of voice will be video recorded so that blinded raters can compare the accuracy and intensity of facial expressions and tones of voice between the participants. Training for the raters will include familiarization with the descriptions of features for each emotion with respect to changes in pitch, loudness, and rate for prosody and changes in facial features for facial expression. Both intra- and inter-judge reliability will be calculated for these blinded judges. To supplement this perceptual analysis, the participant's responses will be recorded using VisiPitch IV software, a clinical instrument that performs sound analyses and calculates the variation in the range of fundamental frequency (i.e., pitch variation) across each sentence. The ability to manipulate pitch to produce varying prosodic contours is the most salient acoustical feature of affective prosody.
We will also assess intensity ratings and descriptions of emotional pictures and words using materials that have established rating norms. Participants will be shown a series of pictures and asked to rate the emotional intensity of the picture. They will also be asked to give a brief description of the picture. They will then be given a list of words, one at a time, and asked to rate the emotional intensity of these words.
Some of the cerebellar participants will also be asked to participate in a magnetic resonance imaging (MRI) scan of the brain if the testing listed above shows deficits in understanding or producing emotional facial expressions or tones of voice and if there are no reasons that would prevent them from being able to enter a scanner (determined by a standard MRI screen form). Healthy control participants may also be asked to participate in a magnetic resonance imaging (MRI) scan of the brain and if there are no reasons that would prevent them from being able to enter a scanner. The imaging data will be used to investigate if there is a relationship between our experimental subjects' performance on tests of emotional expression and left versus right cerebellar atrophy-injury in the cerebellar lobules with MRI imaging using a voxel based morphometry (VBM) approach. The same data from controls will be used for comparison. 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. Structural MP-RAGE T1-weighted scans will be acquired with 130-1.0 mm sagittal slices, FOV=240 mm (AP)-180 mm (FH), matrix= 256-192, TR= 9.90 ms, TE= 4.60 ms, Flip Angle= 8, voxel size= 1.0x 0.94x 0.94 mm. Structural data will be analyzed with FSL-VBM, an optimized VBM protocol carried out with FSL tools. First, structural images will be brain-extracted and grey matter-segmented before being registered to the MNI 152 standard space using non-linear registration The resulting images will be averaged and flipped along the x-axis to create a left-right symmetric, study-specific grey matter template. Second, all native grey matter images will be non-linearly registered to this study-specific template and "modulated" to correct for local expansion (or contraction) due to the non-linear component of the spatial transformation. The modulated grey matter images were then smoothed with an isotropic Gaussian kernel with a sigma of 6 mm. Finally, voxelwise GLM will be applied using permutation-based non-parametric testing, correcting for multiple comparisons across space.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebellar Ataxia subjects | – | Behavioral: Testing of emotional communication ability, Procedure: magnetic resonance imaging (MRI) of the brain40 individuals with either hereditary or sporadic ataxia will have testing of emotional communication ability and may have magnetic resonance imaging (MRI) of the brain. |
| Healthy Control subjects | – | Behavioral: Testing of emotional communication ability, Procedure: magnetic resonance imaging (MRI) of the brain40 age matched controls will have testing of emotional communication ability and may have magnetic resonance imaging (MRI) of the brain. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Men and women over the age of 18
- Individuals with cerebellar ataxia
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testing of emotional communication abilityAssessment of comprehension and expression of emotional facial and prosodic expressions and assessment of emotional reactivity via ratings of emotionally evocative pictures and words. | Behavioural | Cerebellar Ataxia subjects, Healthy Control subjects |
| magnetic resonance imaging (MRI) of the brainCerebellar 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. | Procedure or surgery | Cerebellar Ataxia subjects, Healthy Control subjects |
Primary outcome
Florida Affect Battery
Time frame: baseline
Comprehension of emotional facial and prosodic expressions assessed via identification, discrimination and matching tasks.
3 secondary outcomes
Perceptual rating of emotional expression
Time frame: baseline
Intensity and valence ratings of emotionally evocative pictures and words
Time frame: baseline
Magnetic resonance imaging of the brain
Time frame: approximately one week post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Background: PubMed 23020242Heilman 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.
Related trials for Cerebellar Diseases
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
Active, not recruiting
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Friedreich Ataxia
Recruiting
Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome.
Friedreich's Ataxia, Motor Disorders
Active, not recruitingObservational study
Natural History of Spinocerebellar Ataxia Type 7 (SCA7)
Spinocerebellar Ataxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth M Heilman, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebellar Diseases, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Florida Affect Battery (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02106819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.