Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

NCT06111027 | Completed Phase 1 Results DMC

• 1 other identifier: STUDY00019659
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The general aim of the study was to provide evidence for the usability and feasibility of applying vibro-tactile stimulation (VTS) at home as a non-invasive form of neuromodulation to improve speech in people with spasmodic dysphonia (laryngeal dystonia). This work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options.

Conditions

Spasmodic Dysphonia; Laryngeal Dystonia

Keywords

in-home therapy; vibration; vibro-tactile; laryngeal dystonia

Outcome Measures

Primary Outcomes (4)

• Perceived Speech Effort (PSE) at Week 4

  Perceived Speech Effort was self-rated by participants on a 0-10 scale (0 = no effort, 10 = maximum effort) while reading standardized sentences at habitual pitch and loudness. Ratings were collected immediately before and after each vibro-tactile stimulation session. The PSE value reported here reflects the group mean at week 4.

  Week 4

• Perceived Speech Effort (PSE) at Week 8

  Perceived Speech Effort was self-rated by participants on a 0-10 scale (0 = no effort, 10 = maximum effort) while reading standardized sentences at habitual pitch and loudness. Ratings were collected immediately before and after each vibro-tactile stimulation session. The PSE value reported here reflects the group mean at week 8.

  Week 8

• Voice Quality Change (VQC) at Week 1

  Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral). Ratings were recorded at the end of each VTS session. VQC at week 1 represents a baseline measure of symptom severity. It was computed as the mean of the first three sessions of VTS of the study.

  Week 1

• Voice Quality Change (VQC) at Week 8

  Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral). Ratings were recorded at the end of each VTS session. The score reflects the overall longitudinal change in symptoms experienced after treatment end. VQC at week 8 was computed as the mean of the last three sessions of the study.

  Week 8

Secondary Outcomes (2)

• Relative Change in Perceived Speech Effort (rPSE) for VTS Application Method

  8 weeks

• Adherence Rate (Feasibility)

  Week 1-4

Study Arms (1)

Intervention

EXPERIMENTAL

Laryngeal vibro-tactile stimulation

Device: Vibro-tactile stimulation

Interventions

Vibro-tactile stimulation DEVICE

Participants received vibro-tactile stimulation (VTS) as a non-invasive treatment option. Stimulators were a pair of light-weight encapsulated cylindrical vibrators applied to both sides of the larynx (voice box). The vibration frequency for VTS was set be to 100Hz. During VTS, participants feel a mild tingling or vibrating sensation at their larynx. They applied VTS at home over a period of 8 weeks with a daily dosage of 20 minutes. During weeks 1-4, the weekly dosage of VTS was gradually increased (week 1: 3 days/wk; week 2: 4 days/wk; week 3: 5 days/wk; week 4: 6 days/wk). During weeks 5-8, participants applied VTS on self-selected days as needed, not exceeding 6 times a week.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
• Diagnosis is made by a voice disorder specialist.

You may not qualify if:

• Regular intake of benzodiazepines
• Cognitive impairment: score \< 27 on Mini-mental state examination
• 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

Sponsors & Collaborators

• University of Minnesota: lead
• National Spasmodic Dysphonia Association: collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (3)

• 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 BACKGROUND

• Mahnan A, Xu J, Oh J, Bhaskaran D, Zhang Y, Watson PJ, Konczak J. Laryngeal Vibration to Treat Abductor-Type Laryngeal Dystonia: Effectiveness and Cortical Response. Laryngoscope. 2026 Jan;136(1):368-376. doi: 10.1002/lary.70020. Epub 2025 Aug 8.

  PMID: 40776766 BACKGROUND

• Amini S, Elangovan N, Ozkul C, Konczak J. Usability and Feasibility of In-home Vibro-Tactile Stimulation for Treating Voice Symptoms in Laryngeal Dystonia. J Voice. 2025 Aug 23:S0892-1997(25)00329-7. doi: 10.1016/j.jvoice.2025.08.012. Online ahead of print.

  PMID: 40850907 RESULT

Related Links

• Human Sensorimotor Control Laboratory - Information on studies using vibro-tactile stimulation to treat focal dystonia of the neck and larynx

MeSH Terms

Conditions

Dysphonia

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

Limitations and Caveats

This single-arm, non-randomized study without a control condition was designed to establish the feasibility and usability of prolonged in-home use of VTS for people with LD (spasmodic dysphonia). Ratings of perceived speech effort and voice quality proved to be useful markers of user experience. The obtained data on treatment effectiveness warrant careful interpretation, because the study did not constitute a randomized controlled clinical trial.

Results Point of Contact

• Title: Jürgen Konczak, Ph.D.
• 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: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor; Director Human Sensorimotor Control Laboratory

Model Details: Usability study

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 1, 2023
• Study Start: November 21, 2023
• Primary Completion: October 28, 2024
• Study Completion: October 31, 2024
• Last Updated: July 15, 2026
• Results First Posted: June 25, 2026

Record last verified: 2026-06

Locations

US (1)