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Emotional Prosody Treatment in Parkinson's

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional prosodic treatment
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Prosody, Communication, Dysarthria

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
    • Hoehn and Yahr (H&Y) (Hoehn & Yahr, 1967) scores
  • The investigators will include subjects with H&Y Stages between 2 and 4
  • Participants must be judged as having at least a mild level of affective prosodic deficit in pretreatment testing

Exclusion Criteria:

  • Individuals will be excluded with other forms of Parkinsonism such as:

    • multiple systems atrophy
    • Lewy body dementia
    • progressive supranuclear palsy
  • Other exclusionary criteria will be:

    • 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).

Sites / Locations

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Emotional prosodic treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2013
Last Updated
November 14, 2019
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01956266
Brief Title
Emotional Prosody Treatment in Parkinson's
Official Title
Treatment of Emotional Prosodic Disorders in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
May 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Individuals with Parkinson's disease (PD) present with a variety of motor symptoms including resting tremor, difficulty initiating movement/slowed movements, and rigidity. While these motor signs and symptoms are the hallmark features, individuals with PD also often demonstrate changes in communication ability, with an estimated prevalence of 89 percent of all individuals with PD being affected. These disorders of communication have been reported by individuals with PD and their caregivers to be one of the most difficult aspects of living with this disorder. The most commonly diagnosed communicative disorder in PD is hypokinetic dysarthria which can result in changes in prosody, respiratory control, voice quality, and articulation. Of these, the disorders in prosody have been judged to be the most prominent deficit. Prosody includes the pitch, loudness, and rate with which speech utterances are produced and is used to communicate emotional connotation (e.g. angry versus sad). Impairments in speech prosody reduce the ability to communicate emotional feelings or intentions as well as reducing the intelligibility of the spoken message. While pharmacological treatments have been shown to be effective in improving motor function, these medications have not been shown to greatly mitigate speech production disorders including prosody, suggesting that therapies other than dopaminergic agents are needed to address prosody deficits in PD. Despite a negative impact on quality of life and reduced independence of individuals affected by emotional prosodic disorders, no published studies are available testing therapies to improve production of emotional prosody in PD. The primary goal of this proposal is to compare a treatment protocol shown to be effective in treating emotional prosodic deficit in stroke and TBI (Leon et al., 2005; Rosenbek et al., 2006) to a standard clinical treatment for prosody deficit that does not target the emotional aspect of the disorder in individuals with PD. The experimental treatment targets increased pitch and loudness variability, and control of speech rate, the core characteristics of prosodic insufficiency in PD, but with an emphasis on the emotional component of the disorder. The primary aims of the study are to determine treatment effect size by measuring the difference of the experimental protocol versus standard clinical care on prosodic deficit in individuals with PD via changes in acoustic and perceptual measures, as well as provide psychometric validation of test-retest reliability of the outcome measures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Prosody, Communication, Dysarthria

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group, pretest postest behavioral treatment design
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Emotional prosodic treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Emotional prosodic treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from pre to post treatment in perceptual and acoustic analysis of sentences spoken in emotional tones.
Description
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.
Time Frame
Administered before initiation of treatment and after 8 treatment sessions over an expected average of 3 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Hoehn and Yahr (H&Y) (Hoehn & Yahr, 1967) scores The investigators will include subjects with H&Y Stages between 2 and 4 Participants must be judged as having at least a mild level of affective prosodic deficit in pretreatment testing Exclusion Criteria: Individuals will be excluded with other forms of Parkinsonism such as: multiple systems atrophy Lewy body dementia progressive supranuclear palsy Other exclusionary criteria will be: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan A Leon, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System, Gainesville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.

Learn more about this trial

Emotional Prosody Treatment in Parkinson's

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