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NCT00488657 · ClinicalTrials.gov registry record · Phase 1
Improve Speech Using an In-the-ear Device in Parkinson's Disease
A Phase 1 study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00488657: Completed Phase 1 study, sponsored by Rush University Medical Center.
NCT00488657 is a Phase 1 study that has completed, run by Rush University Medical Center. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00488657, a Phase 1 study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
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.
Interventions
- DEVICE SpeechEasy Model ITC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2006-06 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT00488657 record still lists
NCT00488657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which SpeechEasy Model ITC is the first listed.
NCT00488657 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00488657 about?
NCT00488657 is a clinical study titled "Improve Speech Using an In-the-ear Device in Parkinson's Disease". 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...
What is the current status of trial NCT00488657?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2006-06. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00488657?
The interventions under investigation include: SpeechEasy Model ITC (DEVICE).
Who is sponsoring clinical trial NCT00488657?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00488657's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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