Transcranial Magnetic Stimulation in Laryngeal Dystonia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversidade Federal de Pernambuco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other forms of dystonia
Vocal fold lesions
Vocal fold paralysis
Contraindications to repetitive transcranial magnetic stimulation (rTMS)
Trial design
Design model
Crossover
Treatments tested in this trial
Active rTMS
DeviceActive repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.
Sham rTMS
DeviceSham repetitive transcranial magnetic stimulation (rTMS) delivered using a sham stimulation procedure designed to mimic active rTMS without delivering therapeutic magnetic stimulation.
Speech-Language Therapy
DeviceStandardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist according to the study protocol.
Treatment groups
20 Participants
are divided into 3 treatment groupsGroup A: Active rTMSExperimental treatment 1 intervention
Group B: Active rTMS + Speech-Language TherapyExperimental treatment 2 interventions
Group C: Sham rTMS + Speech-Language TherapySham comparator 2 interventions
Trial outcomes
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.
Time frame
through study completion, an average of 6 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsOther outcomes
1
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 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: