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Sensory Block + Brain Imaging for Spasmodic Dysphonia

Q: Are older adults being welcomed to participate in this experiment?

Recruitment for this research is open to <a href="https://www.withpower.com/clinical-trials/all">all</a> adults aged 18 and above, who are not older than 80 years.

Q: Is it possible to be admitted into this research program?

This medical trial is seeking 165 participants between the ages of 18 and 80 to evaluate the efficacy of a tremor medication. The eligibility criteria thus necessitate both age restrictions, as well as an existing case of tremors.

Q: How many participants are currently enrolled in this experiment?

Affirmative. As observed on clinicaltrials.gov, this research endeavor, which was opened to the public on March 24th 2022, is actively looking for participants. The team needs 165 individuals from 1 medical facility to join their investigation.

Q: Are there any open recruitment slots for this clinical trial?

Clinicaltrials.gov currently lists this trial as accepting new participants, the initial posting of which was on March 24th 2022 with a more recent update posted August 10th in the same year.

Phase < 1

Recruiting

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18-80 years

Native English speakers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will use brain imaging to study the differences between two similar voice disorders, in hopes of better understanding each one's pathophysiology.

Who is the study for?

This trial is for native English-speaking, right-handed adults aged 18-80 who are healthy or have laryngeal dystonia or voice tremor. Excluded are those with other neurological issues, psychiatric disorders, certain laryngeal conditions, history of brain/laryngeal surgery affecting anatomy/function, tattoos/objects unsafe for MRI, and use of central nervous system drugs.Check my eligibility

What is being tested?

The study aims to understand the differences in brain function between laryngeal dystonia and voice tremor using a sensory block with bupivacaine and advanced brain imaging techniques to identify disorder-specific neural activity patterns.See study design

What are the potential side effects?

Potential side effects may include discomfort from the sensory block procedure with bupivacaine and typical risks associated with MRI scans such as claustrophobia or reactions to contrast agents if used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 80 years old.

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I am a native English speaker.

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My thinking and memory skills are normal.

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I do not have any brain, mental health, or ear-related issues.

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I have a voice disorder due to muscle spasms or tremors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effects of sensorimotor brain modulation on voice function in laryngeal dystonia

Effects of sensorimotor brain modulation on voice function in voice tremor

Functional MRI, MEG and EEG signal changes in laryngeal dystonia compared to voice tremor

Trial Design

3Treatment groups

Experimental Treatment

Group I: Spatial and temporal CNS pathophysiology of laryngeal dystonia and voice tremorExperimental Treatment1 Intervention

Simultaneous fMRI with EEG and MEG imaging will be used to examine neural dynamics during phonation.

Group II: Sensorimotor modulations on CNS pathophysiology of laryngeal dystonia and voice tremorExperimental Treatment2 Interventions

Topical laryngeal block will be used to modulate somatosensory feedback from the laryngeal mucosa during speech production and examine associated changes in brain activity. The role of auditory feedback processing on task-induced speech sensorimotor activity will be examined using MEG imaging during perturbing pitch or formants of auditory feedback, unpredictably during speech production, and examining the behavioral and neural correlates of the resulting within-trial compensation responses.

Group III: Motor learning and CNS pathophysiology of laryngeal dystonia and voice tremorExperimental Treatment1 Intervention

Implicit learning of the production of motor sequences will be examined during simultaneous fMRI/EEG and MEG imaging. Sensorimotor adaptation of speech production during MEG imaging will be examined during perturbing pitch or formants of auditory feedback consistently during speech production and examining the behavioral and neural correlates of the resulting across-trial adaptation responses.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor

106 Previous Clinical Trials

12,784 Total Patients Enrolled

2 Trials studying Spasmodic Dysphonia

285 Patients Enrolled for Spasmodic Dysphonia

University of California, San FranciscoOTHER

2,505 Previous Clinical Trials

15,237,390 Total Patients Enrolled

4 Trials studying Spasmodic Dysphonia

193 Patients Enrolled for Spasmodic Dysphonia

Kristina Simonyan, MD, PhDStudy DirectorProfessor of Otolaryngology - Head and Neck Surgery

8 Previous Clinical Trials

2,069 Total Patients Enrolled

5 Trials studying Spasmodic Dysphonia

619 Patients Enrolled for Spasmodic Dysphonia

Media Library

Brain Imaging Clinical Trial Eligibility Overview. Trial Name: NCT05216770 — Phase < 1

Spasmodic Dysphonia Research Study Groups: Sensorimotor modulations on CNS pathophysiology of laryngeal dystonia and voice tremor, Motor learning and CNS pathophysiology of laryngeal dystonia and voice tremor, Spatial and temporal CNS pathophysiology of laryngeal dystonia and voice tremor

Spasmodic Dysphonia Clinical Trial 2023: Brain Imaging Highlights & Side Effects. Trial Name: NCT05216770 — Phase < 1

Brain Imaging 2023 Treatment Timeline for Medical Study. Trial Name: NCT05216770 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are older adults being welcomed to participate in this experiment?

"Recruitment for this research is open to all adults aged 18 and above, who are not older than 80 years."

Answered by AI

Is it possible to be admitted into this research program?

"This medical trial is seeking 165 participants between the ages of 18 and 80 to evaluate the efficacy of a tremor medication. The eligibility criteria thus necessitate both age restrictions, as well as an existing case of tremors."

Answered by AI

How many participants are currently enrolled in this experiment?

"Affirmative. As observed on clinicaltrials.gov, this research endeavor, which was opened to the public on March 24th 2022, is actively looking for participants. The team needs 165 individuals from 1 medical facility to join their investigation."

Answered by AI

Are there any open recruitment slots for this clinical trial?

"Clinicaltrials.gov currently lists this trial as accepting new participants, the initial posting of which was on March 24th 2022 with a more recent update posted August 10th in the same year."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor

Kristina Simonyan 2022. "Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05216770.

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