Parkinson DiseaseNCT01956266
Emotional Prosody Treatment in Parkinson's
A study testing Emotional prosodic treatment in people with Parkinson Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Emotional prosodic treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 31 May 2017
- Phase
- Interventional
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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)
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System, Gainesville, FL
Gainesville, Florida, 32608
About this study
Official title: Treatment of Emotional Prosodic Disorders in Parkinson's Disease
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).
Read the 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
- Being tested
- Emotional prosodic treatment
- Keywords
- Prosody, Communication, Dysarthria
- Medical subject headings
- Parkinson Disease, Communication, Dysarthria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotional prosodic treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Emotional prosodic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Administered before initiation of treatment and after 8 treatment sessions over an expected average of 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start1 Oct 2013
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group, pretest postest behavioral treatment design
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Susan A Leon, PhD, Principal investigator, North Florida/South Georgia Veterans Health System, Gainesville, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956266
- Sponsor's protocol ID
- O0958-M
- Status last verified
- Nov 2019
- First submitted
- 13 Sep 2013
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Emotional Prosodic Disorders in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01956266
- Acronym / sponsor ID
- O0958-M
- Conditions
- Parkinson Disease
- Keywords
- Prosody, Communication, Dysarthria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 8 Oct 2013 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, pretest postest behavioral treatment design
| Arm | Type | Receives |
|---|---|---|
| Emotional prosodic treatment | Experimental | Behavioral: Emotional prosodic treatmentThe 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. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Experimental subjects must meet the Brain Bank criteria (Gibb \& Lees, 1988) for idiopathic PD.
- All participants must:
- The investigators will obtain information about participant's Parkinson's disease history from medical records including:
- 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
Key exclusion criteria (10 listed)
- Individuals will be excluded with other forms of Parkinsonism such as:
- Other exclusionary criteria will be:
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 |
|---|---|---|
| Emotional prosodic treatmentThe 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. | Behavioural | Emotional prosodic treatment |
Primary outcome
Change from pre to post treatment in perceptual and acoustic analysis of sentences spoken in emotional tones.
Time frame: Administered before initiation of treatment and after 8 treatment sessions over an expected average of 3 weeks.
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.
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 18 Nov 2019.
- Individual participant dataSharing planned: Yes. 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.
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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.
Susan A Leon, PhD principal investigator
North Florida/South Georgia Veterans Health System, Gainesville, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotional prosodic treatment in people with Parkinson Disease, run by VA Office of Research and Development 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 18 inclusion and 10 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 18 Nov 2019. 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?
Change from pre to post treatment in perceptual and acoustic analysis of sentences spoken in emotional tones. (time frame: Administered before initiation of treatment and after 8 treatment sessions over an expected average of 3 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2019.