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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 is a Phase 1 study that has completed, run by Rush University Medical Center. The registered enrollment target is 40 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00488657
The ClinicalTrials.gov registry entry for NCT00488657 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which SpeechEasy Model ITC is the first listed.
NCT00488657 reports 0 study locations.
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.
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