Emotional Prosody Treatment in Parkinson's

NCT ID: NCT01956266

Last Updated: 2019-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-01
• Study Completion Date: 2017-05-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Emotional prosodic treatment

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.

Group Type: EXPERIMENTAL

Emotional prosodic treatment

Intervention Type: BEHAVIORAL

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.

Interventions

Emotional prosodic treatment

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.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan A Leon, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

O0958-M

Identifier Type: -

Identifier Source: org_study_id