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Not yet recruiting NCT07683767

Transcranial Magnetic Stimulation in Laryngeal Dystonia

No phase Interventional Laryngeal Dystonia Spasmodic Dysphonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active rTMS, Sham rTMS, Speech-Language Therapy.
Who it may be relevant to
Registry conditions: Laryngeal Dystonia, Spasmodic Dysphonia. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device Active rTMS
    Active repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.
  • Device Sham rTMS
    Sham repetitive transcranial magnetic stimulation (rTMS) delivered using a sham stimulation procedure designed to mimic active rTMS without delivering therapeutic magnetic stimulation.
  • Device Speech-Language Therapy
    Standardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist according to the study protocol.

Primary outcome measures

  • Acoustic Voice Parameters Assessed Using VoxMetria® and FonoView® Software [Time frame: through study completion, an average of 6 months]
Secondary outcome measures (3)
  • Vocal Effort Assessed by the Borg Category Ratio 10 Scale for Vocal Effort [Time frame: through study completion, an average of 6 months]
  • Patient Global Impression of Change Assessed by the Patient Global Impression of Change Scale [Time frame: through study completion, an average of 6 months]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07683767 · rTMS_Laryngeal_Dystonia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗