Understanding Disorder-specific Neural Pathophysiology in Laryngeal Dystonia and Voice Tremor
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMassachusetts Eye and Ear Infirmary
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males and females of diverse racial and ethnic background;
Age 18-80 years;
Native English speakers;
Right-handed;
Disqualifiers
Subjects who are incapable of giving informed consent;
Pregnant or breastfeeding women until a time when they are no longer pregnant or breastfeeding. All women of childbearing potential will have a urine pregnancy test performed before MRI, which must be negative for participation in the imaging studies;
Subjects with a past or present medical history of (a) neurological problems, such as stroke, movement disorders (other than specified LD and VT in the patient groups), brain tumors, traumatic brain injury with loss of consciousness, ataxias, myopathies, myasthenia gravis, demyelinating diseases; (b) psychiatric problems, such as schizophrenia, bipolar depression, obsessive-compulsive disorder, alcoholism, drug dependence; (c) laryngeal problems, such as vocal fold paralysis, paresis, vocal fold nodules and polyps, carcinoma, chronic laryngitis;
Patients with any other form of dystonia;
Trial design
Design model
Parallel
Treatments tested in this trial
Brain imaging
Other interventionBrain images will be conducted with function MRI, magnetoencephalography (MEG), and electroencephalography (EEG) to identify disorder-specific neural markers
Laryngeal sensory block with topical bupivacaine
DrugLaryngeal 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
Treatment groups
165 Participants
are divided into 5 treatment groupsGroup A: Spatial and temporal CNS pathophysiology of laryngeal dystonia and voice tremorOther 1 intervention
Group B: Sensorimotor modulations of laryngeal dystonia and voice tremor with bupivacaineActive comparator 1 intervention
Group C: Motor learning and CNS pathophysiology of laryngeal dystonia and voice tremorOther 1 intervention
Group D: Placebo effects in laryngeal dystonia and voice tremorPlacebo comparator 0 interventions
Group E: Auditory feedback processing in laryngeal dystonia and voice tremorOther 1 intervention
Trial outcomes
Primary outcomes
1
Functional MRI, MEG and EEG signal changes in laryngeal dystonia compared to voice tremor
Qualitative analysis of brain regions with disorder-specific increases and decreases of spatial (functional MRI) and temporal (MEG and EEG) signals will be determined in patients with laryngeal dystonia compared to patients with voice tremor
Time frame
5 years2
Effects of sensorimotor brain modulation on voice function in laryngeal dystonia
Quantitative measures of symptoms will be determined using Burk-Fahn-Marsden Dystonia Rating Scale where higher score means a worse outcome, following sensorimotor feedback modulation in patients with laryngeal dystonia
Time frame
5 years3
Effects of sensorimotor brain modulation on voice function in voice tremor
Quantitative measures of symptoms will be determined using Fahn-Tolosa-Marin Rating Scale where higher score means a worse outcome, following sensorimotor feedback modulation in patients with voice tremor
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts Eye and Ear Infirmary
Lead sponsor
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov