Improve Speech Using an In-the-ear Device in Parkinson's Disease (MJFFSpeech)
Primary Purpose
Parkinson's Disease, Dysarthria
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SpeechEasy Model ITC
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring speech, Parkinson's disease, treatment, speech intelligibility, speaking rate
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease, presence of speech problems, native English speaker
Exclusion Criteria:
- previous brain surgery, presence of dementia or depression, profound hearing loss, previous strokes or neurological disorders/conditions other than Parkinson's disease
Sites / Locations
- Rush University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
In the ear device to provide altered auditory feedback
Outcomes
Primary Outcome Measures
speech intelligibility
Secondary Outcome Measures
hearing changes
speaking rate
Full Information
NCT ID
NCT00488657
First Posted
June 18, 2007
Last Updated
January 17, 2013
Sponsor
Rush University Medical Center
Collaborators
Michael J. Fox Foundation for Parkinson's Research
1. Study Identification
Unique Protocol Identification Number
NCT00488657
Brief Title
Improve Speech Using an In-the-ear Device in Parkinson's Disease
Acronym
MJFFSpeech
Official Title
Treating Speech Disorders in Patients With Parkinson's Disease Using Altered Auditory Feedback
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center
Collaborators
Michael J. Fox Foundation for Parkinson's Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Dysarthria
Keywords
speech, Parkinson's disease, treatment, speech intelligibility, speaking rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
In the ear device to provide altered auditory feedback
Intervention Type
Device
Intervention Name(s)
SpeechEasy Model ITC
Intervention Description
The delayed auditory feedback ranging from 50 to 220 ms, and the altered frequency feedback ranging from 500 to 2,000 Hz.
Primary Outcome Measure Information:
Title
speech intelligibility
Time Frame
1 year
Secondary Outcome Measure Information:
Title
hearing changes
Time Frame
1 year
Title
speaking rate
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease, presence of speech problems, native English speaker
Exclusion Criteria:
previous brain surgery, presence of dementia or depression, profound hearing loss, previous strokes or neurological disorders/conditions other than Parkinson's disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Wang, PHD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leo Verhagen, MD, PHD
Organizational Affiliation
Rush University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
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Improve Speech Using an In-the-ear Device in Parkinson's Disease
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