An interventional study of Active rTMS and Sham rTMS in Laryngeal Dystonia and Spasmodic Dysphonia, sponsored by Universidade Federal de Pernambuco. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Universidade Federal de Pernambuco · Not applicable, Interventional, and Treatment
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.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's planned enrollment of 20 is below the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →Universidade Federal de Pernambuco is the lead sponsor of 166 studies on the registry; 22 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive active repetitive transcranial magnetic stimulation (rTMS) alone, delivered according to the study protocol, without concurrent speech-language therapy.
Device: Active rTMS
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
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
Active repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.
Sham repetitive transcranial magnetic stimulation (rTMS) delivered using a sham stimulation procedure designed to mimic active rTMS without delivering therapeutic magnetic stimulation.
Standardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist according to the study protocol.
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.
Time frame: through study completion, an average of 6 months
Vocal Effort Assessed by the Borg Category Ratio 10 Scale for Vocal Effort
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.
Time frame: through study completion, an average of 6 months
Patient Global Impression of Change Assessed by the Patient Global Impression of Change Scale
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.
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)
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.
Time frame: through study completion, an average of 6 months
Perceptual-auditory voice assessment
Perceptual-auditory evaluation of voice quality performed by trained raters, based on standardized speech and sustained vowel tasks.
Time frame: through study completion, an average of 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2026; primary completion for Aug 2026, 2 months later.
Of 44 non-industry interventional studies with no phase under Dysphonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's planned 2 months is below that.
Counting every sponsor, half of 44 studies reached it within 26 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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