Health TrialsbyHealthPanel

Brain Network Changes After Vibro-tactile Stimulation in Laryngeal Dystonia

ConditionLaryngeal Dystonia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Minnesota

About this trial

Laryngeal dystonia (LD) is a focal dystonia affecting laryngeal muscles, causing involuntary spasms that impair speech production. Recent research demonstrated that non-invasive vibrotactile stimulation (VTS) of the laryngeal area can provide acute symptom relief in up to 57% of patients, with improvements in voice quality and reductions in perceived speech effort lasting from minutes to several days. However, the neural mechanisms underlying this therapeutic effect and the factors determining individual treatment response remain incompletely understood. The objective is to evaluate the acute effects of VTS on voice and speech parameters in participants with LD while characterizing associated changes in brain resting-state networks using magnetic resonance imaging (MRI).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Diagnosis of laryngeal dystonia previously made by a voice disorder specialist and confirmed by Dr. Misono, UM Otolaryngology.

Disqualifiers

Regular intake of benzodiazepines

Cognitive impairment: score < 27 on Mini-mental state examination; score > 19 on Beck depression inventory

Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis

Subjects with any type of bio-implant activated by mechanical, electronic, or magnetic means (e.g. cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vibrotactile Stimulation (VTS)

    Device

    Applied to the laryngeal area using a non-invasive vibrating device.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Laryngeal Dystonia PatientsActive comparator 1 intervention
Group B: Healthy ControlsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Brain Resting-State Functional Connectivity due to VTS

Resting state functional connectivity (rs-fMRI) refers to the brain's activity when a person is not engaged in any specific task. It measures spontaneous fluctuations in the blood oxygen level-dependent (BOLD) signal, which indicates brain activity. The rs-fMRI will be obtained twice before and after receiving VTS and the change in rs-fMRI will be obtained.

Time frame
Hour 2.5

Secondary outcomes

1

Cepstral Peak Prominence Smoothed

Cepstral Peak Prominence Smoothed (CPPs) is a quantitative acoustic measure used to assess voice quality. It is measured in decibel (dB) and will be derived from voice recordings of the participant. An increase in dB is associated with a louder and clearer voice in people with laryngeal dystonia.

Time frame
Hour 0.5
2

Changes in Perceived Speech Effort

Perceived speech effort (PSE) will be rated by each participant on a scale of 0-10 (10 indicates maximum vocal effort). Participants will assess their PSE before and after VTS treatment. A reduction in PSE indicates a reduced effort to speak.

Time frame
Hour 0.5
3

Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score

The Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) inventory (scale of 0-100 with 100 indicating severe dysphonia; score between 30-65 = moderate symptoms, 65-100 = severe symptoms) will be obtained based on the audio recordings from each participant. A speech-language pathologist will rate the audio recordings and derive the CAPE-V for each participant before and after VTS treatment.

Time frame
Hour 0.5
4

Voice Handicap Index

The Voice Handicap Index (VHI) is a self-rated 30-item inventory to indicate the impact of experienced voice problems or a voice disorder (score range: 0-120, score between 0-30 = mild severity; 31-60 = moderate severity; 61-120 = severe severity).

Time frame
Hour 0.5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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