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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT05216770
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Laryngeal Dystonia
  • Spasmodic Dysphonia
  • Tremor

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Brain imaging — OTHER
    Brain images will be conducted with function MRI, magnetoencephalography (MEG), and electroencephalography (EEG) to identify disorder-specific neural markers
  • Laryngeal sensory block with topical bupivacaine — DRUG
    Laryngeal sensory block with bupivacaine will be used to modulate sensory feedback from vocal fold mucosa and examine the impact of sensory feedback on abnormal neural activity in LD and VT

Study Details

The researchers will examine functional neural correlates that differentiate between laryngeal dystonia and voice tremor and contribute to disorder-specific pathophysiology using a cross-disciplinary approach of multimodal brain imaging.

Key Dates

Start date
Mar 24, 2022
Status verified
Nov 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
165 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Other: Spatial and temporal CNS pathophysiology of laryngeal dystonia and voice tremor
    Simultaneous fMRI with EEG and MEG imaging will be used to examine neural dynamics during phonation.
  • Active Comparator: Sensorimotor modulations of laryngeal dystonia and voice tremor with bupivacaine
    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.
  • Other: Motor learning and CNS pathophysiology of laryngeal dystonia and voice tremor
    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.
  • Placebo Comparator: Placebo effects in laryngeal dystonia and voice tremor
    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.
  • Other: Auditory feedback processing in laryngeal dystonia and voice tremor
    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.

Primary Outcome Measure

Functional MRI, MEG and EEG signal changes in laryngeal dystonia compared to voice tremor [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and Ear and University of California San FranciscoBostonMassachusetts02114
Kristina Simonyan, MD, PhD
[email protected]
617-573-6016
Kristina Simonyan, MD, PhD (PRINCIPAL_INVESTIGATOR)
Srikantan Nagarajan, PhD (PRINCIPAL_INVESTIGATOR)
John Houde, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Massachusetts Eye and Ear and University of California San Francisco· Boston, MA

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