Parkinson's Disease Clinical Trial
— MJFFSpeechOfficial title:
Treating Speech Disorders in Patients With Parkinson's Disease Using Altered Auditory Feedback
Verified date | January 2013 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 25 Years to 90 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | Michael J. Fox Foundation for Parkinson's Research |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | speech intelligibility | 1 year | No | |
Secondary | hearing changes | 1 year | Yes | |
Secondary | speaking rate | 1 year | No |
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