Laryngeal Vibration for Spasmodic Dysphonia

NCT03746509 | Completed Results DMC

• 2 other identifiers: KIN-2022-30628-2R01DC016315
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of people with spasmodic dysphonia (SD). This research addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options. A successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving the voice symptoms in SD. Specifically, the scientific yield by achieving the specific aims is threefold: First, it will elucidate the unknown neurophysiological mechanism behind laryngeal VTS by documenting the neural changes associated with VTS. Second, it will establish that VTS can improve voice quality in SD. Third, by documenting that laryngeal VTS yields long-term benefits on voice quality in SD patients, it would provide a solid basis for a clinical trial that needs to address open questions on optimal dosage and duration of VTS-based voice therapy, the magnitude of the therapeutic effect across adductor and abductor SD and its long term efficacy.

Conditions

Spasmodic Dysphonia

Keywords

Dystonia; Spasmodic dysphonia; Laryngeal dystonia

Outcome Measures

Primary Outcomes (2)

• Voice Assessment During First Visit

  Smoothed Cepstral Peak Prominence (CPPS) is an indicator of voice quality. It is measured in decibels. CPPS was measured from the voice signals of each participant during each study visit, and relative CPPS was calculated before and after vibration was applied on the laryngeal muscles of the participants. An increase in CPPS value indicates an improvement in voice symptoms.

  Testing performed in lab at Week 1

• Final Voice Assessment

  Smoothed Cepstral Peak Prominence (CPPS) which is an indicator of voice quality was measured in participants. CPPS was measured in participants during the first visit, and relative CPPS was calculated before and after vibration was applied on the laryngeal muscles of the participants.

  Testing performed in lab at week 11

Secondary Outcomes (2)

• Measuring of Cortical Activity Using Electroencephalography (EEG) (Baseline)

  Testing performed in lab at Week 1

• Final Measuring of Cortical Activity Using Electroencephalography (EEG) to Measure Change From Baseline

  Testing performed in lab at Week 11

Study Arms (4)

Low-High Treatment

EXPERIMENTAL

Participants in the low-high treatment group will receive Laryngeal Vibration (Treatment) at 100Hz frequency once a week for a duration of 4 weeks (low intensity). Then they will switch and receive laryngeal vibration at 100Hz frequency every second day of the week (high intensity) for a duration of 4 weeks.

Device: Laryngeal Vibration (Treatment)

High-Low Treatment

EXPERIMENTAL

Participants in the high-low treatment group will receive Laryngeal Vibration (Treatment) at 100Hz frequency every second day of the week for a duration of 4 weeks (high intensity). Then they will switch and receive laryngeal vibration at 100Hz frequency once a week for a duration of 4 weeks (low intensity).

Device: Laryngeal Vibration (Treatment)

Low-High Comparator

ACTIVE COMPARATOR

Participants in the low-high comparator group will receive Laryngeal Vibration (Comparator) at 5Hz frequency once a week for a duration of 4 weeks (low intensity). Then they will switch and receive laryngeal vibration at 5Hz frequency every second day of the week (high intensity) for a duration of 4 weeks.

Device: Laryngeal Vibration (Comparator)

High-Low Comparator

ACTIVE COMPARATOR

Participants in the high-low comparator group will receive Laryngeal Vibration (Comparator) at 5Hz frequency every second day of the week for a duration of 4 weeks (high intensity). Then they will switch and receive laryngeal vibration at 5Hz frequency once a week for a duration of 4 weeks (low intensity).

Device: Laryngeal Vibration (Comparator)

Interventions

Laryngeal Vibration (Treatment) DEVICE

The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.

High-Low Treatment; Low-High Treatment

Laryngeal Vibration (Comparator) DEVICE

The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.

High-Low Comparator; Low-High Comparator

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of adductor SD for a minimum of 6 months with documented symptom relief after botox injection

You may not qualify if:

• abductor SD
• patients with other voice disorders such as muscle tension dysphonia that share some of the symptomology with SD

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (2)

• Khosravani S, Mahnan A, Yeh IL, Aman JE, Watson PJ, Zhang Y, Goding G, Konczak J. Laryngeal vibration as a non-invasive neuromodulation therapy for spasmodic dysphonia. Sci Rep. 2019 Nov 29;9(1):17955. doi: 10.1038/s41598-019-54396-4.

  PMID: 31784618 BACKGROUND

• Konczak J, Bhaskaran D, Elangovan N, Oh J, Goding GS, Watson PJ. Effects of an 11-week vibro-tactile stimulation treatment on voice symptoms in laryngeal dystonia. Front Neurol. 2024 May 30;15:1403050. doi: 10.3389/fneur.2024.1403050. eCollection 2024.

  PMID: 38872829 RESULT

Related Links

• Invesitgator laboratory website summarizing study results

MeSH Terms

Conditions

Dysphonia; Dystonia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias

Limitations and Caveats

Dosage was limited to apply vibro-tactile stimulation for one day or days per week for 20 min/day. It is unclear how a more frequent or longer application of the stimulation will affect voice outcome in people with laryngeal dystonia.

Results Point of Contact

• Title: Juergen Konczak
• Organization: University of Minnesota

jkonczak@umn.edu

612-624-4370

Study Officials

• Juergen Konczak, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 19, 2018
• Study Start: April 2, 2019
• Primary Completion: July 20, 2022
• Study Completion: July 20, 2022
• Last Updated: May 4, 2025
• Results First Posted: March 15, 2024

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)