Parkinson's DiseasePhase 1MJFFSpeechNCT00488657
Improve Speech Using an In-the-ear Device in Parkinson's Disease
A Phase 1 study testing SpeechEasy Model ITC in people with Parkinson's Disease and Dysarthria, run by Rush University Medical Center at 1 site in United States.
Trial summary
This project will systematically examine the therapeutic effect of altered auditory feedback provided by the in-the-ear device on the speech impairments in patients with Parkinson's disease. Many patients with PD have difficulty starting their speech even though they know the words they want to say. Read more about this study
- Who is it for?
- Ages 25 to 90 years
- Conditions the study is for
- Parkinson's Disease, Dysarthria
- What is being tested?
- SpeechEasy Model ITC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to May 2010
- Phase
- Phase 1
- 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 25 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease, presence of speech problems, native English speaker
Who cannot join
- previous brain surgery, presence of dementia or depression, profound hearing loss, previous strokes or neurological disorders/conditions other than Parkinson's disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Treating Speech Disorders in Patients With Parkinson's Disease Using Altered Auditory Feedback
This project will systematically examine the therapeutic effect of altered auditory feedback provided by the in-the-ear device on the speech impairments in patients with Parkinson's disease.
Many patients with PD have difficulty starting their speech even though they know the words they want to say. They experience 'freezing' of the jaw, tongue and lips. When they eventually get their speech started, they have a hard time moving it forward. They keep on saying the same words or phrases over and over again while their voice gets softer and softer. Many words also run together. These symptoms make patients' speech very hard to understand and directly affect their care and quality of life. Currently, there is no effective medical or surgical treatment for these speech symptoms.
We have tested an in-the-ear therapeutic device that provides altered auditory feedback in eight patients with PD and moderate to severe speech impairment and the results are encouraging. We will recruit 100 patients with PD and moderate to severe speech impairment for Phase A and 20 for Phase B of the study. They will use the device routinely to provide the altered auditory feedback as they speak to improve their speech intelligibility.
Read the detailed description
Speech problems are common in patients with Parkinson's disease (PD). At an early stage, patients may find it hard to project their voice. As the disease progresses, patients start to have difficulty starting their speech even though they know the words they want to say. They experience 'freezing' of the jaw, tongue and lips. When they eventually get their speech started, they have a hard time moving it forward. They keep on saying the same words or phrases over and over again while their voice gets softer and softer. Many words also run together or are slurred. These symptoms make patients' speech very hard to understand and directly affect their care and quality of life. Unfortunately, these symptoms have not responded to medication or surgery like other non-speech motor symptoms do. In fact, some surgical treatment could even make speech worse while other motor function such as walking improves. Traditional behavior therapy for these speech symptoms has not been successful either because these symptoms cannot be controlled voluntarily.
Recently, we have tested an in-the-ear therapeutic device that provides altered auditory feedback in eight patients with PD and moderate to severe speech impairment. The device is housed in a hearing aid shell, and it is programmable. Patients wore the device in one ear and heard their own speech through it after a short time delay and with a shift in pitch while they spoke. The delay ranged from 50-220 ms and their pitch shifted up or down from 500-2,000 Hz. For each patient, a specific combination of the time-delay and pitch-shift was found. Our preliminary results were encouraging. Seven of the eight PD patients made significant improvement in their speech, and they were much easier to understand when they used the device.
This project will systematically examine the therapeutic effect of altered auditory feedback provided by the in-the-ear device on the speech impairments in PD. We will recruit 100 patients with PD and moderate to severe speech impairment for Phase A and 20 for Phase B of the study. The Phase A study will be a single visit while the Phase B study will be over a one-year period while the patients use the device to provide the altered auditory feedback as they speak. Both short-term and long-term benefits of altered auditory feedback on speech will be monitored. Based on the results of our preliminary study, we expect the patients' speech will improve. We hypothesize that the use of altered auditory feedback provides salient sensory information that triggers ancillary loops to allow PD patients to initiate their speech more easily and to maintain a constant speaking rate, thus making their speech more intelligible. This project has the potential to significantly impact the quality of life for patients with PD. When PD patients can express their wants and needs and can communicate effectively with their families, caretakers and physicians, their quality of life improves.
- Conditions
- Parkinson's Disease, Dysarthria
- Being tested
- SpeechEasy Model ITC
- Keywords
- speech, Parkinson's disease, treatment, speech intelligibility, speaking rate
- Medical subject headings
- Parkinson Disease, Dysarthria, Speech, Speech Intelligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpeechEasy Model ITCDevice
The delayed auditory feedback ranging from 50 to 220 ms, and the altered frequency feedback ranging from 500 to 2,000 Hz.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | In the ear device to provide altered auditory feedback Receives: Device: SpeechEasy Model ITC |
What is being measured
The primary outcome is the main question the study is designed to answer.
speech intelligibility
Measured: 1 year
Secondary outcomes (2)
hearing changes
Measured: 1 year
speaking rate
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJun 2006
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Emily Wang, Rush University Medical Center
- Investigators
- Emily Wang, PHD, Principal investigator, Rush University Medical CenterLeo Verhagen, MD, PHD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488657
- Sponsor's protocol ID
- RushUMC
- Acronym
- MJFFSpeech
- Status last verified
- Jan 2013
- First submitted
- 18 Jun 2007
- Last updated
- 18 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Speech Disorders in Patients With Parkinson's Disease Using Altered Auditory Feedback
- ClinicalTrials.gov ID
- NCT00488657
- Acronym / sponsor ID
- MJFFSpeech / RushUMC
- Conditions
- Parkinson's Disease, Dysarthria
- Keywords
- speech, Parkinson's disease, treatment, speech intelligibility, speaking rate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Jun 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 20 Jun 2007 (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 project will systematically examine the therapeutic effect of altered auditory feedback provided by the in-the-ear device on the speech impairments in patients with Parkinson's disease.
Many patients with PD have difficulty starting their speech even though they know the words they want to say. They experience 'freezing' of the jaw, tongue and lips. When they eventually get their speech started, they have a hard time moving it forward. They keep on saying the same words or phrases over and over again while their voice gets softer and softer. Many words also run together. These symptoms make patients' speech very hard to understand and directly affect their care and quality of life. Currently, there is no effective medical or surgical treatment for these speech symptoms.
We have tested an in-the-ear therapeutic device that provides altered auditory feedback in eight patients with PD and moderate to severe speech impairment and the results are encouraging. We will recruit 100 patients with PD and moderate to severe speech impairment for Phase A and 20 for Phase B of the study. They will use the device routinely to provide the altered auditory feedback as they speak to improve their speech intelligibility.
Detailed description
Speech problems are common in patients with Parkinson's disease (PD). At an early stage, patients may find it hard to project their voice. As the disease progresses, patients start to have difficulty starting their speech even though they know the words they want to say. They experience 'freezing' of the jaw, tongue and lips. When they eventually get their speech started, they have a hard time moving it forward. They keep on saying the same words or phrases over and over again while their voice gets softer and softer. Many words also run together or are slurred. These symptoms make patients' speech very hard to understand and directly affect their care and quality of life. Unfortunately, these symptoms have not responded to medication or surgery like other non-speech motor symptoms do. In fact, some surgical treatment could even make speech worse while other motor function such as walking improves. Traditional behavior therapy for these speech symptoms has not been successful either because these symptoms cannot be controlled voluntarily.
Recently, we have tested an in-the-ear therapeutic device that provides altered auditory feedback in eight patients with PD and moderate to severe speech impairment. The device is housed in a hearing aid shell, and it is programmable. Patients wore the device in one ear and heard their own speech through it after a short time delay and with a shift in pitch while they spoke. The delay ranged from 50-220 ms and their pitch shifted up or down from 500-2,000 Hz. For each patient, a specific combination of the time-delay and pitch-shift was found. Our preliminary results were encouraging. Seven of the eight PD patients made significant improvement in their speech, and they were much easier to understand when they used the device.
This project will systematically examine the therapeutic effect of altered auditory feedback provided by the in-the-ear device on the speech impairments in PD. We will recruit 100 patients with PD and moderate to severe speech impairment for Phase A and 20 for Phase B of the study. The Phase A study will be a single visit while the Phase B study will be over a one-year period while the patients use the device to provide the altered auditory feedback as they speak. Both short-term and long-term benefits of altered auditory feedback on speech will be monitored. Based on the results of our preliminary study, we expect the patients' speech will improve. We hypothesize that the use of altered auditory feedback provides salient sensory information that triggers ancillary loops to allow PD patients to initiate their speech more easily and to maintain a constant speaking rate, thus making their speech more intelligible. This project has the potential to significantly impact the quality of life for patients with PD. When PD patients can express their wants and needs and can communicate effectively with their families, caretakers and physicians, their quality of life improves.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: SpeechEasy Model ITCIn the ear device to provide altered auditory feedback |
Who may qualify
- Ages
- 25 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinson's disease, presence of speech problems, native English speaker
Key exclusion criteria (1 listed)
- previous brain surgery, presence of dementia or depression, profound hearing loss, previous strokes or neurological disorders/conditions other than Parkinson's disease
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 |
|---|---|---|
| SpeechEasy Model ITCThe delayed auditory feedback ranging from 50 to 220 ms, and the altered frequency feedback ranging from 500 to 2,000 Hz. | Device | 1 |
Primary outcome
speech intelligibility
Time frame: 1 year
2 secondary outcomes
hearing changes
Time frame: 1 year
speaking rate
Time frame: 1 year
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 Jan 2013.
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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.
Emily Wang, PHD principal investigator
Rush University Medical Center
Leo Verhagen, MD, PHD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SpeechEasy Model ITC in people with Parkinson's Disease and Dysarthria, run by Rush University Medical Center 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 1 inclusion and 1 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 Jan 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
speech intelligibility (time frame: 1 year). 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 Jan 2013; AzTrials last refreshed its copy on 1 Nov 2026.