NCT00488657|CompletedPhase 1
Improve Speech Using an In-the-ear Device in Parkinson's Disease
MJFFSpeech
Treating Speech Disorders in Patients With Parkinson's Disease Using Altered Auditory Feedback
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MJFFSpeech
Treating Speech Disorders in Patients With Parkinson's Disease Using Altered Auditory Feedback
Sponsor study identifier
interventional
40
1 country
1
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 18, 2007
Actual (reported)June 20, 2007
Actual (reported)May 2010
Actual (reported)May 2010
Actual (reported)speech intelligibility
1 year
hearing changes
1 year
speaking rate
1 year
In the ear device to provide altered auditory feedback
The delayed auditory feedback ranging from 50 to 220 ms, and the altered frequency feedback ranging from 500 to 2,000 Hz.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Rush University Medical Center
Chicago, Illinois, 60612, United States
Emily Wang, PHD
Rush University Medical Center
Leo Verhagen, MD, PHD
Rush University Medical Center
40 participants (actual enrollment reported by the registry).
First Submitted
June 18, 2007
First Posted
June 20, 2007
Study Start
June 2006
Date type not reportedThis date has not been verified as actual or estimated.
Continuously Infused Intracerebral (IC) Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (r-metHuGDNF) for the Treatment of Idiopathic Parkinson's Disease
Investigating the Safety of srTMS in the Treatment of Parkinson's Disease
Contact the study team to confirm eligibility.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
January 18, 2013
Record last verified: 2013-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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