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NCT01124292 · ClinicalTrials.gov registry record · Phase 1
Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis
A Phase 1 study, sponsored by Georgia Institute of Technology.
- Completed
- Registry status
- Phase 1
- Development phase
- 61
- Enrollment target
NCT01124292: Completed Phase 1 study, sponsored by Georgia Institute of Technology.
NCT01124292 is a Phase 1 study that has completed, run by Georgia Institute of Technology. The registered enrollment target is 61 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01124292, a Phase 1 study, has completed, sponsored by Georgia Institute of Technology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 61 participants
- Enrollment target
Study Summary
This study was intended to evaluate a new assistive neuro-technology, known as the Tongue Drive System (TDS), by its potential end-users, i.e. individuals with severe disabilities, who are the best experts for indicating the benefits and possible shortcomings of any new ANT. Our goal is to assess the acceptability and usability of the TDS for various tasks that are important in daily lives of these individuals, such as computer access, wheeled mobility, and environmental control.
Primary Outcome
Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second". The high value of throughput means
Interventions
- PROCEDURE Tongue Piercing
- DEVICE Usability assessment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01124292 record still lists
NCT01124292 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Tongue Piercing is the first listed.
NCT01124292 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01124292 about?
NCT01124292 is a clinical study titled "Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis". This study was intended to evaluate a new assistive neuro-technology, known as the Tongue Drive System (TDS), by its potential end-users, i.e. individuals with severe disabilities, who are the best experts for indicating the benefits and possible shortcomings of any new ANT. Our goal is to assess th...
What is the current status of trial NCT01124292?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2010-05. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01124292?
The interventions under investigation include: Tongue Piercing (PROCEDURE), Usability assessment (DEVICE).
Who is sponsoring clinical trial NCT01124292?
This trial is sponsored by Georgia Institute of Technology, which has 24 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01124292's enrollment target sits among peer trials
61 828th of 2000 higher than 1,170 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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