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NCT Number: NCT07683767

Transcranial Magnetic Stimulation in Laryngeal Dystonia

This randomized clinical trial with a crossover design aims to investigate the effects of neuromodulation through repetitive transcranial magnetic stimulation (rTMS) applied to patients diagnosed with laryngeal dystonia. Participants will undergo three experimental conditions: (1) rTMS alone, (2) rTMS combined with speech-language therapy, and (3) sham rTMS combined with speech-language therapy. The order of the conditions will be randomized. Each phase of the protocol will consist of five consecutive sessions.

Outcomes will include acoustic vocal quality parameters, perceptual-auditory voice assessment, self-ratings of vocal effort, smoothed cepstral peak prominence measures, and global perceived change following the intervention. It is expected that the study will contribute to a better understanding of the effects of the intervention on vocal outcomes, supporting the optimization and standardization of therapeutic protocols for laryngeal dystonia.

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Key information

Conditions

Laryngeal Dystonia Dysphonia Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Spasmodic Dysphonia Voice Disorders

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18 years) of any sex with a confirmed diagnosis of laryngeal dystonia
  • Participants not undergoing botulinum toxin treatment at the time of the intervention
  • Ability to provide informed consent
  • Ability to complete all study assessments and intervention procedures

Exclusion criteria

  • Other forms of dystonia
  • Vocal fold lesions
  • Vocal fold paralysis
  • Contraindications to repetitive transcranial magnetic stimulation (rTMS)
  • Inability to complete study assessments or intervention procedures

Treatment and study plan

Active rTMS

Device

Active repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.

sham rTMS

Device

Sham repetitive transcranial magnetic stimulation (rTMS) delivered using a sham stimulation procedure designed to mimic active rTMS without delivering therapeutic magnetic stimulation.

Speech-Language Therapy

Device

Standardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist according to the study protocol.

Primary outcomes

  1. Acoustic Voice Parameters Assessed Using VoxMetria® and FonoView® Software

    Time frame: through study completion, an average of 6 months

    Acoustic voice parameters will be assessed using VoxMetria and FonoView software during sustained vowel phonation and connected speech tasks. The analysis will include F0 standard deviation (F0 SD), F0 variability, semitone variability, jitter, cepstral peak prominence smoothed (CPPS), voiced time, and unvoiced time. Each parameter will be analyzed separately and reported as the change from baseline to post-intervention.

Secondary outcomes

  1. Vocal Effort Assessed by the Borg Category Ratio 10 Scale for Vocal Effort

    Time frame: through study completion, an average of 6 months

    Vocal effort will be assessed using the Borg Category Ratio 10 Scale for Vocal Effort. Scores range from 0 to 10, where 0 indicates no vocal effort and 10 indicates maximum vocal effort. Higher scores indicate worse perceived vocal effort.

  2. Patient Global Impression of Change Assessed by the Patient Global Impression of Change Scale

    Time frame: through study completion, an average of 6 months

    Global perceived change will be assessed using the Patient Global Impression of Change Scale. Scores range from 1 to 7, where 1 = very much worse and 7 = very much improved. Higher scores indicate greater perceived improvement.

  3. Voice-Related Quality of Life Assessed by the Voice-Related Quality of Life Questionnaire (Brazilian Portuguese Version - QVV)

    Time frame: through study completion, an average of 6 months

    Voice-related quality of life will be assessed using the Voice-Related Quality of Life (V-RQOL) questionnaire, validated for Brazilian Portuguese (QVV). Scores range from 0 to 100, with higher scores indicating better voice-related quality of life.

Other outcomes

  1. Perceptual-auditory voice assessment

    Time frame: through study completion, an average of 6 months

    Perceptual-auditory evaluation of voice quality performed by trained raters, based on standardized speech and sustained vowel tasks.

Study contacts

Contact information is provided by the study sponsor or research team.

Katia K Monte-Silva

CONTACT

[email protected]

+55(81) 99503-2493

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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