Laryngeal DystoniaNCT07683767
Transcranial Magnetic Stimulation in Laryngeal Dystonia
A study testing Active rTMS and Speech-Language Therapy in people with Laryngeal Dystonia and Spasmodic Dysphonia, run by Universidade Federal de Pernambuco.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laryngeal Dystonia, Spasmodic Dysphonia
- What is being tested?
- Active rTMS and Speech-Language Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Active rTMS, Sham rTMS, Speech-Language Therapy
- Keywords
- Repetitive transcranial magnetic stimulation, Neuromodulation, Vocal quality
- Medical subject headings
- Dysphonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rTMSDevice
Active repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.
Sham rTMSDevice
Sham repetitive transcranial magnetic stimulation (rTMS) delivered using a sham stimulation procedure designed to mimic active rTMS without delivering therapeutic magnetic stimulation.
Speech-Language TherapyDevice
Standardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Participants will receive active repetitive transcranial magnetic stimulation (rTMS) alone, delivered according to the study protocol, without concurrent speech-language therapy. Receives: 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. Receives: 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. Receives: Device: Sham rTMS; Device: Speech-Language Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 6 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngeal DystoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Nathália Suellen Valeriano Cardoso Cardoso, Principal investigator, UFPE - nathalia.suellen@ufpe.br
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683767
- Sponsor's protocol ID
- rTMS_Laryngeal_Dystonia
- Status last verified
- Jun 2026
- First submitted
- 20 Jan 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No