Parkinson's Disease Clinical Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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