Laryngeal Dystonia, Spasmodic Dysphonia
Conditions
Keywords
Repetitive transcranial magnetic stimulation, Neuromodulation, Vocal quality
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.
Interventions
DEVICEActive rTMS
Active repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.
DEVICESham rTMS
Sham repetitive transcranial magnetic stimulation (rTMS) delivered using a sham stimulation procedure designed to mimic active rTMS without delivering therapeutic magnetic stimulation.
DEVICESpeech-Language Therapy
Standardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist according to the study protocol.
Sponsors
Universidade Federal de Pernambuco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, care providers, and outcome assessors will be blinded to intervention condition (active vs sham).
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acoustic Voice Parameters Assessed Using VoxMetria® and FonoView® Software | 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
| Measure | Time frame | Description |
|---|---|---|
| Vocal Effort Assessed by the Borg Category Ratio 10 Scale for Vocal Effort | 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. |
| Patient Global Impression of Change Assessed by the Patient Global Impression of Change Scale | 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. |
| 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 | 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. |
Contacts
CONTACTKatia K Monte-Silva
PRINCIPAL_INVESTIGATORNathália Suellen Valeriano Cardoso Cardoso
UFPE - nathalia.suellen@ufpe.br
Outcome results
None listed