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| Name | Class |
|---|---|
| National Spasmodic Dysphonia Association | OTHER |
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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.
Participants with either adductor or abductor-type of spasmodic dysphonia applied VTS at home for a period of 2 months. During the first four weeks they gradually increased their weekly dosage from 3 to 6 days per week. Each application per day lasted 20 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Laryngeal vibro-tactile stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in Perceived Speech Effort (rPSE) for VTS Application Method | Relative change in PSE (rPSE) was calculated as [(Post - Pre) / Pre] × 100. The between-group difference in mean rPSE comparing VTS received during direct skin contact vs. VTS collar was assessed over the total study period of 8 weeks to understand if the VTS applied directly to the skin was more effective in reducing speech effort than VTS applied via the collar. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juergen Konczak, PhD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55414 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38872829 | 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. | |
| 40776766 | 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. |
| Label | URL |
|---|---|
| Human Sensorimotor Control Laboratory - Information on studies using vibro-tactile stimulation to treat focal dystonia of the neck and larynx | View source |
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Data collection occurred between the 21st November 2023 and the 28th October 2024. Recruitment ended on 29th October 2024. A total of 40 participants were enrolled. Of these, 34 participants began study procedures and 32 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Participants received vibro-tactile stimulation as a non-invasive treatment option. Stimulators were a pair of light-weight encapsulated cylindrical vibrators 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vibro-tactile Stimulation Treatment | Participants received vibro-tactile stimulation as a non-invasive treatment option. Stimulators were a pair of light-weight encapsulated cylindrical vibrators attached to to both sides of the larynx (voice box) either by taping them directly to the skin or by wearing them in a collar (no direct skin contact). The vibration frequency for VTS was set 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Score on a scale of 1-10 | Week 4 |
|
Adverse events were collected from the start of the intervention through the end of the study period (e.g., after 8 weeks of home-based VTS use).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Participants received vibro-tactile stimulation as a non-invasive treatment option. Stimulators were a pair of light-weight encapsulated cylindrical vibrators attached to to both sides of the larynx (voice box) either by taping them directly to the skin or by wearing them in a collar (no direct skin contact). The vibration frequency for VTS was set 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening of pre-existing tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jürgen Konczak, Ph.D. | University of Minnesota | 612-624-4370 | jkonczak@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2024 | Apr 3, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2023 | Apr 3, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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Usability study
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|
| 8 weeks |
| Adherence Rate (Feasibility) | Number of participants who completed at least 80% of prescribed VTS sessions during the intervention period. Thirty out of 32 participants (93.75%) met this adherence threshold | Week 1-4 |
| 40850907 | Result | 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. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Perceived Speech Effort | Perceived Speech Effort prior to receiving treatment 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. | Mean | Standard Deviation | Score on a scale of 1-10 |
|
|
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| Primary | 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. | Posted | Mean | Standard Deviation | Score on a scale | Week 8 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Unitless score on a scale between 1-5 | Week 1 |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Unitless score on a scale between 1-5 | Week 8 |
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| Secondary | Relative Change in Perceived Speech Effort (rPSE) for VTS Application Method | Relative change in PSE (rPSE) was calculated as [(Post - Pre) / Pre] × 100. The between-group difference in mean rPSE comparing VTS received during direct skin contact vs. VTS collar was assessed over the total study period of 8 weeks to understand if the VTS applied directly to the skin was more effective in reducing speech effort than VTS applied via the collar. | Posted | Mean | 95% Confidence Interval | Percentage | 8 weeks |
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| Secondary | Adherence Rate (Feasibility) | Number of participants who completed at least 80% of prescribed VTS sessions during the intervention period. Thirty out of 32 participants (93.75%) met this adherence threshold | Posted | Count of Participants | Participants | Week 1-4 |
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| 0 |
| 32 |
| 0 |
| 32 |
| 2 |
| 32 |
| New-onset tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |