Muscle Activity Analysis for Hoarseness

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
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 aims to understand how the neck and head muscles function during speaking and after voice strain. Researchers will use a new tool, the Computational Cranial and Cervical Muscle Network, to study muscle activity in individuals with and without voice disorders such as muscle tension dysphonia (a condition where muscles around the voice box are tight) and unilateral vocal fold paralysis (where one vocal cord doesn't move). Participants may qualify if they have been recommended voice therapy for muscle tension dysphonia or have received a vocal cord injection for paralysis. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the understanding and treatment of voice disorders.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diagnostic tool is safe for analyzing muscle activity?

Research shows that the Computational Cranial and Cervical Muscle Network treatment is being tested to understand the function of head and neck muscles. This is crucial for diagnosing and treating voice problems such as muscle tension dysphonia and unilateral vocal fold paralysis. Studies have not identified any major safety concerns with this method.

In similar research, patients with muscle tension dysphonia did not experience serious side effects when their muscle activity was assessed before and after voice therapy. Another study involving patients with vocal fold issues found that measuring muscle networks was well-tolerated. These findings suggest the treatment is safe.

This phase of the trial provides sufficient evidence to support the treatment's safety. Researchers are carefully monitoring the treatment to ensure participant safety. For those considering joining this trial, current data suggests it is a safe option.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover new insights into how cranial and cervical muscle networks behave during vocal tasks in different conditions. Unlike current treatments for voice disorders that focus primarily on symptom management, this trial uses advanced computational analysis to map muscle activity patterns. By understanding these patterns, scientists hope to develop more targeted therapies for conditions like muscle tension dysphonia and vocal fold paralysis, potentially leading to personalized treatment strategies that are more effective than the generalized approaches available today.

What evidence suggests that this computational cranial and cervical muscle network is effective for analyzing muscle activity related to hoarseness?

This trial will compare different groups using the Computational Cranial and Cervical Muscle Network to understand and treat conditions like muscle tension dysphonia and unilateral vocal fold paralysis. Research has shown that checking muscle networks before and after treatments, such as voice therapy or vocal fold injections, can help track improvements in voice disorders. In this trial, patients with muscle tension dysphonia will undergo voice therapy, and the network will measure improvements in muscle function. Meanwhile, patients with unilateral vocal fold paralysis will receive vocal fold injections, and the network will monitor enhancements in vocal function. These findings suggest that the network could be a valuable tool in evaluating and guiding treatment for voice disorders.12678

Who Is on the Research Team?

AJ

Aaron Johnson

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with muscle tension dysphonia or unilateral vocal cord paralysis, recommended for voice therapy or vocal fold injection medialization. Participants must be able to consent and complete assessments. Excluded are those with allergies to the device, 'smart' implants, recent head/neck surgery, open wounds near sensors, abnormal laryngeal structures, or involvement in other investigational studies.

Inclusion Criteria

Control Group: Willingness to complete all clinical/research assessments
I am over 18 years old.
I have been diagnosed with one-sided vocal cord paralysis and advised to get a vocal fold injection.
See 6 more

Exclusion Criteria

Experimental Group: Participation in additional clinical research studies using investigational treatments
I had surgery on my head or neck in the last 3 months.
Control Group: Participation in additional clinical research studies using investigational treatments
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline sEMG measurements and vocal tasks are conducted to assess cervical-cranial muscle network activity

1 visit
1 visit (in-person)

Treatment

Participants undergo vocal loading tasks and receive interventions such as voice therapy or vocal fold medialization

2 months
2 visits (in-person)

Follow-up

Participants are monitored for changes in pitch, loudness, and phonatory effort after treatment

2 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Computational Cranial and Cervical Muscle Network
Trial Overview The study aims to develop a new diagnostic tool by measuring muscle activity in the neck and head using surface electromyogram (sEMG) and flexible laryngoscopy. It will compare typical voicing against disordered conditions before and after vocal fatigue to understand neuromuscular mechanisms better.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Vocally Healthy ControlsExperimental Treatment2 Interventions
Group II: Unilateral Vocal Fold Paralysis PatientsExperimental Treatment1 Intervention
Group III: Muscle Tension Dysphonia PatientsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials
377
Recruited
190,000+

Citations

Computational Cranial and Cervical Muscle Network in ...In Experiment 2 (Aim 2), we will measure muscle networks in patients with muscle tension dysphonia before and after a course of voice therapy. Patients with ...
Computational Cranial and Cervical Muscle Network in ...Patients with muscle tension dysphonia will be measured at baseline and approximately 2 months after their baseline visit following a standard ...
Perilaryngeal Functional Muscle Network in Patients with ...In this paper, for the first time, we evaluate the performance and symmetry of functional perilaryngeal muscle networks in three patients with ...
On the complexity matching and multiscale nonlinear ...Unilateral vocal fold paralysis (UVFP) is a voice disorder characterised by impaired motility of a single vocal fold. In the general population, ...
Emerging techniques in assessment and treatment of ...Purpose of review: The purpose of this review is to summarize current evidence regarding treatment for muscle tension dysphonia (MTD) and to present recent ...
Perilaryngeal Functional Muscle Network in Patients with ...For this, the study includes eight healthy subjects and three patients (one diagnosed with primary muscle tension dysphonia, one diagnosed with.
Perilaryngeal Functional Muscle Network in Patients with ...Patient 1 was diagnosed with primary muscle tension dysphonia, Patient 2 was diagnosed with unilateral vocal fold paresis, and Patient 3 was diagnosed with age- ...
Unilateral Vocal Fold Paralysis - StatPearls - NCBI BookshelfUnilateral vocal fold paralysis is characterized by abnormal movement of the true vocal folds, with reduced mobility (paretic) or complete cessation of ...
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