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Sensory Block + Brain Imaging for Spasmodic Dysphonia

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

Must not have

To avoid the confounding effect of centrally acting drugs, all study participants will be questioned about any prescribed or over-the-counter medications as part of their initial screening. Those patients who receive medication(s) affecting the central nervous system will be excluded

Patients who have dystonia symptoms at rest or have a presence of mirror dystonia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any medications that affect the brain.

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I experience muscle contractions without moving or have mirror dystonia.

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I have not had botulinum toxin injections in the last 3 months.

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I have not had any surgery on my head or neck that changed its structure or nerve connections.

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I am unable to understand and give consent for my treatment.

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I have a type of dystonia.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

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: 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.

Group III: Auditory feedback processing in laryngeal dystonia and voice tremorExperimental Treatment1 Intervention

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 IV: Sensorimotor modulations of laryngeal dystonia and voice tremor with bupivacaineActive Control1 Intervention

Topical laryngeal block (1 ml of 0.75% bupivacaine solution) will be used to modulate somatosensory feedback from the laryngeal mucosa during speech production and examine associated changes in brain activity.

Group V: Placebo effects in laryngeal dystonia and voice tremorPlacebo Group1 Intervention

1 ml of saline placebo matching to 1 ml of 0.75% bupivacaine solution will be used for a comparison with the topical laryngeal block to modulate somatosensory feedback from the laryngeal mucosa during speech production and examine associated changes in brain activity.

0 / 11Eligibility criteria met