Emotional Prosody Treatment in Parkinson's
Treatment of Emotional Prosodic Disorders in Parkinson's Disease
1 other identifier
interventional
10
1 country
1
Brief Summary
This study investigates a treatment protocol which holds the potential to significantly improve communication and quality of life for individuals affected by Parkinson's disease (PD). Disorders of emotional communication are widely reported in PD and can negatively impact quality of life by increasing social isolation and decreasing independence. Individuals with emotional prosodic communication disorders are often perceived as depressed or unconcerned about others. This seeming negativity can cause difficulties in relationships, and increased feelings of stress and burden in caregivers which may result in earlier placement in an institutional care setting. This innovative treatment program could improve care for individuals with PD, as well as other individuals who may be affected by disorders of emotional prosodic communication (e.g., stroke or traumatic brain injury).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable parkinson-disease
Started Oct 2013
Longer than P75 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2017
CompletedNovember 18, 2019
November 1, 2019
3.7 years
September 13, 2013
November 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from pre to post treatment in perceptual and acoustic analysis of sentences spoken in emotional tones.
The primary outcome of 96 semantically neutral sentences is read aloud using one of four emotional tones of voice. The participant will be given a card with the sentence and a card denoting the emotional tone to be used when speaking the sentence aloud. Participants will be wearing a headset cardioid microphone with frequency response tailored to vocal use with a shock mount to reduce handling and cable noise. Participant's responses will be recorded using the VisiPitch IV software designed for analysis and feedback and stored for future analysis.
Administered before initiation of treatment and after 8 treatment sessions over an expected average of 3 weeks.
Study Arms (1)
Emotional prosodic treatment
EXPERIMENTALThe experimental treatment is consistent with the standard treatment in that it targets impairments in pitch/stress, loudness variability and control of speech rate, the core characteristics of prosodic insufficiency in PD (Darley, Aronson \& Brown, 1969). However, the experimental treatment provides an innovative and targeted emphasis on the emotional component of the disorder. The production of emotional intonation in an utterance requires varying combinations of pitch/stress, loudness, and rate.
Interventions
The experimental treatment is consistent with the standard treatment in that it targets impairments in pitch/stress, loudness variability and control of speech rate, the core characteristics of prosodic insufficiency in PD (Darley, Aronson \& Brown, 1969). However, the experimental treatment provides an innovative and targeted emphasis on the emotional component of the disorder. The production of emotional intonation in an utterance requires varying combinations of pitch/stress, loudness, and rate. Participants will receive clinician feedback as well as auditory and visual feedback on accuracy via the VisiPitch display.
Eligibility Criteria
You may qualify if:
- Experimental subjects must meet the Brain Bank criteria (Gibb \& Lees, 1988) for idiopathic PD.
- All participants must:
- be between the ages of 45 and 85
- have at least a sixth grade education
- fluent in English
- The investigators will obtain information about participant's Parkinson's disease history from medical records including:
- age at onset
- current age
- gender
- handedness
- level of education
- side of the body initially affected
- information regarding subsequent clinical progression
- medications
- most recent Unified Parkinson Disease Rating Scale (UPDRS) scores
- +3 more criteria
You may not qualify if:
- Individuals will be excluded with other forms of Parkinsonism such as:
- multiple systems atrophy
- Lewy body dementia
- progressive supranuclear palsy
- co-existing dementia (as indicated by score on Montreal Cognitive Assessment of below 26)
- neurological disease other than idiopathic PD
- major depression
- any other psychiatric illness
- chronic medical and neurological diseases other than PD (e.g., cardiac failure, renal disease, hepatic failure, stroke, or severe sensory deficits such as deafness or blindness (corrected visual acuity less than 20/50).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan A Leon, PhD
North Florida/South Georgia Veterans Health System, Gainesville, FL
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2013
First Posted
October 8, 2013
Study Start
October 1, 2013
Primary Completion
May 31, 2017
Study Completion
May 31, 2017
Last Updated
November 18, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will share
A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.