NCT01956266

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

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable parkinson-disease

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2013

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

3.7 years

First QC Date

September 13, 2013

Last Update Submit

November 14, 2019

Conditions

Keywords

ProsodyCommunicationDysarthria

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

EXPERIMENTAL

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.

Behavioral: Emotional prosodic treatment

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.

Emotional prosodic treatment

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Parkinson DiseaseCommunicationDysarthria

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehaviorArticulation DisordersSpeech DisordersLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susan A Leon, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group, pretest postest behavioral treatment design
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.

Locations