Improve Speech Using an In-the-ear Device in Parkinson's Disease

Parkinson's Disease Clinical Trial

— MJFFSpeech  

Official title:

Treating Speech Disorders in Patients With Parkinson's Disease Using Altered Auditory Feedback

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00488657
• Other study ID #: RushUMC
• Status: Completed
• Phase: Phase 1
• First received: June 18, 2007
• Last updated: January 17, 2013
• Start date: June 2006
• Est. completion date: May 2010

Study information

• 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

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysarthria
• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• SpeechEasy Model ITC
The delayed auditory feedback ranging from 50 to 220 ms, and the altered frequency feedback ranging from 500 to 2,000 Hz.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

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