An interventional study of Opti-Speech in Articulation Disorder, Dysarthria and Prelingual Deafness, sponsored by Vulintus, Inc.. Completed at 2 sites in United States. Open to participants aged 12 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-12-31.
Sponsored by Vulintus, Inc. · Not applicable, Interventional, and Treatment
Among 30 studies in Dysarthria with a site in United States — 11 open to participants now, 13 under way, none of them phase 3. Dysarthria · United States.
Among the 30 studies in Dysarthria with a site in United States, this one is the 13th largest by enrollment of the 24 interventional ones, is one of 2 that started in 2016, is one of 23 with no phase, and was the 7th registered.
60 studies on the registry are indexed under Dysarthria; 19 are open to participants now.
This study's enrollment of 37 is close to the median of 39 across 44 interventional studies indexed under Dysarthria.
Browse Dysarthria studies →11 of the 30 studies in Dysarthria with a site in United States are open now, in 2 countries. Each count lists the studies.
Of the 16 Dysarthria studies recruiting now, 7 (44%) set no upper age limit and 5 (31%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 12 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →30 studies; the count open now beside each. This study's row is marked.
First in 1979; this study’s year is marked. 2 started in 2016.
Median enrollment 39 across the 24 interventional studies, 160 across the 6 observational. Of the 15 that completed or were terminated, 3 (20%) have results posted.
3 of 30 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Vulintus, Inc. as lead sponsor.
Vulintus, Inc. has 1 study filed under Dysarthria — fewer than ten, so there is no comparison to draw.
6 of the studies in Dysarthria with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06593860Florida State UniversityDysarthria Management for Minor Groups | 2027-02-28 |
| NCT06817941Rutgers, The State University of New JerseySpeech and Arm Combined Exergame | 2027-04 |
| NCT07357428ParadromicsConnect-One: Early Feasibility Study of Connexus® Brain-Computer Interface (BCI) | 2027-05 |
| NCT05724173Leigh R. Hochberg, MD, PhD.Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia | 2027-07-31 |
| NCT06094205Leigh R. Hochberg, MD, PhD.Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02) | 2027-08-31 |
Among the 30 studies in Dysarthria with a site in United States, from their registry updates:
The purpose of this study is to determine if feedback from a three-dimensional real-time visualization of the tongue, a program called Opti-Speech, can be used to improve speech.
Participants will be asked to complete the Goldman Fristoe Test of Articulation along with several other assessment tests. Then speech treatment, guided by Opti-Speech, will be provided to the participant for up to 10 treatment sessions. The participant will be asked to come back after the final treatment for a 2-month follow-up assessment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Speech treatment will be guided by Opti-Speech's visual feedback of tongue movement during speech
Device: Opti-Speech
Uses visual feedback of the tongue's motion to guide speech sound production
Percent articulatory accuracy
Sound probe lists will be administered within 30 minutes of treatment. Probe lists will be scored as correct or incorrect. The percentage of probes correct will be calculated
Time frame: within 30 minutes of treatment
Change in Accuracy of Speech Sound Production from Pre-Treatment to Post-Treatment
The Goldman Fristoe Test of Articulation will be administered prior to any speech treatment with Opti-Speech and again 2 months after the final speech treatment session. The percentage of consonants correct (PCC) will be used to assess the change in accuracy of speech sound production from pre-treatment to post-treatment
Time frame: Immediately prior to first speech treatment and 2 months after final treatment.
Plan to share: No
Ran from Jan 2016 to primary completion in Aug 2018, 31 months.
Of 34 interventional studies with no phase under Dysarthria, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's 31 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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