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

NCT00488657 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2013-01-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Emily Wang, PHD · Rush University Medical Center

  • Leo Verhagen, MD, PHD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00488657 on ClinicalTrials.gov