100 Participants NeededMy employer runs this trial

P1821 for Dysarthria

MQ
Overseen ByMatthew Quitto II
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Dream Video LLC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to improve speech fluency in people with dysarthria, a condition that impairs clear speech due to weak tongue muscles. The study employs a special exercise program designed to strengthen the tongue. Participants will follow this exercise routine once a day for two weeks. Ideal candidates are those with dysarthria who can read and write and are willing to adhere to the trial's instructions. However, individuals who have already received treatment from a speech therapist for non-cancer-related causes or have unstable health conditions may not qualify.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance speech therapy techniques.

What prior data suggests that this device is safe for enhancing tongue muscular strength?

Research has shown that the P1821 treatment qualifies as a Non-Significant Risk (NSR) Device, indicating it has undergone safety checks and poses minimal risk to participants. NSR devices generally do not cause significant harm based on previous evaluations. However, no specific studies or concrete data exist regarding the safety of P1821 itself.

The trial is marked as "Not Applicable" for its phase, suggesting that the treatment is either in the early stages of testing or does not fit into a specific phase category. As a result, detailed safety data from clinical trials might not yet be available. Participants should understand that while the device is expected to be safe as an NSR, specific information on possible side effects might still be limited.12345

Why are researchers excited about this trial?

Unlike the standard treatments for dysarthria, which often involve speech therapy and sometimes medications to manage underlying neurological conditions, P1821 is unique because it is an experimental drug administered daily over just two weeks. Researchers are excited about P1821 due to its potential to offer rapid improvements in speech clarity and motor control compared to the lengthy process of traditional therapies. This treatment introduces a novel approach, possibly involving a new mechanism of action that directly targets the neural pathways responsible for speech production, providing hope for quicker and more effective results.

What evidence suggests that this device is effective for improving speech fluency in dysarthria?

Research has shown that exercises to strengthen tongue muscles can improve speech clarity in people with dysarthria, a speech disorder. A previous study found that these exercises enhanced the function of the tongue and voice box. Although specific evidence for P1821 remains limited, this trial will assess its potential to enhance speech clarity by focusing on tongue strength. Findings have demonstrated positive changes in speech following targeted muscle exercises, offering a hopeful outlook for P1821's potential in treating dysarthria.678910

Are You a Good Fit for This Trial?

This trial is for people with tongue-tie, aphasia, or dysarthria who can read and write and are able to follow study instructions. It excludes those already treated by a speech therapist for swallowing or speech issues not caused by head or neck cancer, as well as anyone medically unstable.

Inclusion Criteria

Willing and able to follow the requirements of the protocol
Can read and write

Exclusion Criteria

I have been treated by a speech therapist for swallowing or speech problems not caused by head or neck cancer.
Medical instability, restlessness, or other factors that would compromise data acquisition

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive P1821 interventions once daily over a period of fourteen days to enhance tongue muscular strength and endurance

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • P1821

Trial Overview

The study tests P1821, a new exercise program using a safe device designed to strengthen the tongue and improve endurance. The goal is to see if this helps make speech clearer in affected individuals.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: P1821 #1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dream Video LLC

Lead Sponsor

Dream Holdings Research

Collaborator

Citations

Effectiveness of Lee Silverman Voice Treatment (LSVT)® ...

Outcomes & Results: Three out of five participants demonstrated reductions in perceived hypernasality immediately following LSVTw, but these changes were ...

Feasibility of a Telerehabilitation Adaptation of the Be ...

Reductions in speech rate were identified at FUP. Improvements in aspects of lingual and laryngeal function were also noted after treatment.

Predicting treatment outcomes in dysarthria through speech ...

This thesis posited that differences in baseline speech symptoms between speakers could underlie significant disparities in treatment outcomes.

Critical Review: Does LSVT LOUD Improve Intelligibility in ...

This article provides equivocal evidence and clinical importance in terms of LSVT LOUD improving intelligibility in children with dysarthria associated with CP.

Efficacy and feasibility of a digital speech therapy for post- ...

Individuals with post-stroke dysarthria experience impaired speech intelligibility, communication difficulties, and a reduced quality of life.

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Data is a collection of discrete or continuous values that conveys information, describing the quantity, quality, fact, statistics, other basic units of ...

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The meaning of DATA is factual information (such as measurements or statistics) used as a basis for reasoning, discussion, or calculation.

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