Transcranial Magnetic Stimulation in Laryngeal Dystonia
27. juni 2026 oppdatert av: Kátia Monte-Silva, Universidade Federal de Pernambuco
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
20
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Katia K Monte-Silva
- Telefonnummer: +55(81) 99503-2493
- E-post: monte.silva@ufpe.br
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Active rTMS
Participants will receive active repetitive transcranial magnetic stimulation (rTMS) alone, delivered according to the study protocol, without concurrent speech-language therapy.
|
Active repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.
|
|
Eksperimentell: Active rTMS + Speech-Language Therapy
Participants will receive active repetitive transcranial magnetic stimulation (rTMS) combined with speech-language therapy, administered according to the standardized intervention protocol.
|
Active repetitive transcranial magnetic stimulation (rTMS) delivered using a magnetic stimulator according to the study protocol.
Standardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist according to the study protocol.
|
|
Sham-komparator: Sham rTMS + 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.
|
Standardized speech-language therapy focused on voice rehabilitation delivered by a licensed speech-language pathologist 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Acoustic Voice Parameters Assessed Using VoxMetria® and FonoView® Software
Tidsramme: 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.
|
through study completion, an average of 6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Vocal Effort Assessed by the Borg Category Ratio 10 Scale for Vocal Effort
Tidsramme: 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.
|
through study completion, an average of 6 months
|
|
Patient Global Impression of Change Assessed by the Patient Global Impression of Change Scale
Tidsramme: 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.
|
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)
Tidsramme: 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.
|
through study completion, an average of 6 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceptual-auditory voice assessment
Tidsramme: through study completion, an average of 6 months
|
Perceptual-auditory evaluation of voice quality performed by trained raters, based on standardized speech and sustained vowel tasks.
|
through study completion, an average of 6 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Nathália Suellen Valeriano Cardoso Cardoso, UFPE - nathalia.suellen@ufpe.br
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. august 2026
Studiet fullført (Antatt)
1. februar 2027
Datoer for studieregistrering
Først innsendt
20. januar 2026
Først innsendt som oppfylte QC-kriteriene
27. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Sykdommer i luftveiene
- Otorhinolaryngologiske sykdommer
- Laryngeale sykdommer
- Stemmeforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Dysfoni
- Terapeutikk
- Pasientbehandling
- Rehabilitering
- Ettervern
- Kontinuitet i pasientbehandling
- Rehabilitering av tale- og språkforstyrrelser
- Taleterapi
Andre studie-ID-numre
- rTMS_Laryngeal_Dystonia
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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