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

NCT ID: NCT00488657

Last Updated: 2013-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2010-05-31

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.

Conditions

Parkinson's Disease; Dysarthria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

In the ear device to provide altered auditory feedback

Group Type: EXPERIMENTAL

SpeechEasy Model ITC

Intervention Type: DEVICE

The delayed auditory feedback ranging from 50 to 220 ms, and the altered frequency feedback ranging from 500 to 2,000 Hz.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Emily Wang

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emily Wang, PHD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Leo Verhagen, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

Other Identifiers

RushUMC

Identifier Type: -

Identifier Source: org_study_id