Transcranial Magnetic Stimulation in Laryngeal Dystonia

NCT07683767 | Not Yet Recruiting

• 1 other identifier: rTMS_Laryngeal_Dystonia
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Laryngeal Dystonia; Spasmodic Dysphonia

Keywords

Repetitive transcranial magnetic stimulation; Neuromodulation; Vocal quality

Outcome Measures

Primary Outcomes (1)

• Acoustic Voice Parameters Assessed Using VoxMetria® and FonoView® Software

  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.

  through study completion, an average of 6 months

Secondary Outcomes (3)

• Vocal Effort Assessed by the Borg Category Ratio 10 Scale for Vocal Effort

  through study completion, an average of 6 months

• Patient Global Impression of Change Assessed by the Patient Global Impression of Change Scale

  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)

  through study completion, an average of 6 months

Other Outcomes (1)

• Perceptual-auditory voice assessment

  through study completion, an average of 6 months

Study Arms (3)

Active rTMS

EXPERIMENTAL

Participants will receive active repetitive transcranial magnetic stimulation (rTMS) alone, delivered according to the study protocol, without concurrent speech-language therapy.

Device: Active rTMS

Active rTMS + Speech-Language Therapy

EXPERIMENTAL

Participants will receive active repetitive transcranial magnetic stimulation (rTMS) combined with speech-language therapy, administered according to the standardized intervention protocol.

Device: Active rTMS; Device: Speech-Language Therapy

Sham rTMS + Speech-Language Therapy

SHAM COMPARATOR

Participants will receive sham repetitive transcranial magnetic stimulation (rTMS) combined with speech-language therapy. Sham stimulation will mimic active rTMS without delivering therapeutic magnetic stimulation.

Device: Sham rTMS; Device: Speech-Language Therapy

Interventions

Active rTMS DEVICE

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

Active rTMS; Active rTMS + Speech-Language Therapy

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.

Sham rTMS + Speech-Language Therapy

Speech-Language Therapy DEVICE

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

Active rTMS + Speech-Language Therapy; Sham rTMS + Speech-Language Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

MeSH Terms

Conditions

Dysphonia

Interventions

Speech Therapy

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

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Nathália Suellen Valeriano Cardoso Cardoso

  UFPE - nathalia.suellen@ufpe.br

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katia K Monte-Silva

CONTACT

+55(81) 99503-2493; monte.silva@ufpe.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and outcome assessors will be blinded to intervention condition (active vs sham).
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: July 6, 2026
• Study Start: June 1, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share