Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00488657
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2007-06-18
Brief Title:
Improve Speech Using an In-the-ear Device in Parkinsons Disease
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Treating Speech Disorders in Patients With Parkinsons Disease Using Altered Auditory Feedback
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MJFFSpeech
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 Parkinsons 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
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 Parkinsons 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 500-2000 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
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 500-2000 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None