Trial · NCT07894172
EMG-Guided Versus Endoscopic-Catheter Botulinum Toxin Injection for Spasmodic Dysphonia
NCT07894172, Not applicable, Not yet recruiting, Chinese University of Hong Kong
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EMG-Guided Versus Endoscopic-Catheter Botulinum Toxin Injection for Spasmodic Dysphonia. Trials, record NCT07894172. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07894172
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EMG-Guided Versus Endoscopic-Catheter Botulinum Toxin Injection for Spasmodic Dysphonia
- NCT number
- NCT07894172
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 17 participants, estimated
- Lead sponsor
- Chinese University of Hong Kong
- Conditions
- Spasmodic Dysphonia
- Interventions
- Intervention A - Electromyography (EMG)-Guided BTX Injection, Intervention B - Endoscopic Catheter BTX Injection
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Voice Handicap Index (VHI-30) at 4 weeks post-operation | Baseline and 4 weeks post-operation | The Voice Handicap Index (VHI-30) is a 30-item self-administered patient-reported outcome measure for voice-related disability, comprising physical, functional, and emotional subscales. In a scale of 0 (Never), 1 (Seldom), 2 (Occasionally), 3 (Frequently) and 4 (Always). Score range 0-120; higher scores indicate greater handicap. Baseline total score of Voice Handicap Index (VHI-30) will be subtracted from 4-week post-operative total score. |
| Secondary | Change from Baseline in Perceptual Voice Quality Total Score on the Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) Scale at 12 weeks post-operation | Baseline and 12 weeks post-operation | Perceptual rating of voice quality will be evaluated using the GRBAS scale. The scale consists of 5 components: Grade (G), Roughness (R), Breathiness (B), Asthenia (A), and Strain (S). Each component is scored from 0 (normal) to 3 (severe). The total score is calculated by summing the scores of all 5 components. Total scores range from 0 to 15, where a score of 0 represents normal voice quality and a score of 15 represents the most severe voice impairment. Higher scores indicate a worse clinical outcome. Baseline GRBAS total score will be subtracted from the 12-week post-operative total score. A negative change score indicates an improvement in voice quality, while a positive change score indicates a worsening of voice quality. |
| Secondary | Change from Baseline in Perceptual Voice Quality Total Score on the Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) Scale at 4 weeks post-operation | Baseline and 4 weeks post-operation | Perceptual rating of voice quality will be evaluated using the GRBAS scale. The scale consists of 5 components: Grade (G), Roughness (R), Breathiness (B), Asthenia (A), and Strain (S). Each component is scored from 0 (normal) to 3 (severe). The total score is calculated by summing the scores of all 5 components. Total scores range from 0 to 15, where a score of 0 represents normal voice quality and a score of 15 represents the most severe voice impairment. Higher scores indicate a worse clinical outcome. Baseline GRBAS total score will be subtracted from the 4-week post-operative total score. A negative change score indicates an improvement in voice quality, while a positive change score indicates a worsening of voice quality. |
| Secondary | Glottal Closure Type at 4 weeks post-operation | 4 weeks post-operation | Glottal closure configuration will be assessed by videostroboscopy according to the pattern of vocal fold contact during phonation and classified as: 1 = Complete closure; 2 = Anterior Gap; 3=Posterior Gap; 4=Hourglass gap; 5 = Spindle gap; 6 = Irregular gap; 7 = Incomplete closure. A lower numerical category, particularly a transition from an open-gap configuration (categories 2-7) to complete closure (category 1), will be considered an improvement in vocal fold function. |
| Secondary | Glottal Closure Type at 12 weeks post-operation | 12 weeks post-operation | Glottal closure configuration will be assessed by videostroboscopy according to the pattern of vocal fold contact during phonation and classified as: 1 = Complete closure; 2 = Anterior Gap; 3=Posterior Gap; 4=Hourglass gap; 5 = Spindle gap; 6 = Irregular gap; 7 = Incomplete closure. A lower numerical category, particularly a transition from an open-gap configuration (categories 2-7) to complete closure (category 1), will be considered an improvement in vocal fold function. |
| Secondary | Peri-procedural pain at Day 1 | Day 1 | The Numeric Rating Scale (NRS 0-10) is a 11-point self-report tool used to measure peri-procedural pain intensity, where 0 represents "no pain" and 10 represents "the worst pain imaginable". |
| Secondary | Procedural tolerability at Day 1 | Day 1 | Procedural tolerability using a Numeric Rating Scale (NRS) 0-10 measures how well a patient can accept and withstand the study intervention, where 0 means no pain or discomfort, the fully tolerable and 10 means the worst imaginable pain or most intolerable experience possible. |
| Secondary | Difficulty of performing the intervention at Day 1 | Day 1 | The Numeric Rating Scale (NRS) is an 11-point scale (0-10) that can be adapted by a surgeon to quantify the technical difficulty or complexity of performing the study intervention. In a scale of 0 (very easy) to 10 (very difficult). |
| Secondary | Change from Baseline in Voice Handicap Index (VHI-30) at 12 weeks post-operation | Baseline and 12 weeks post-operation | The Voice Handicap Index (VHI-30) is a 30-item self-administered patient-reported outcome measure for voice-related disability, comprising physical, functional, and emotional subscales. In a scale of 0 (Never), 1 (Seldom), 2 (Occasionally), 3 (Frequently) and 4 (Always). Score range 0-120; higher scores indicate greater handicap. Baseline total score of Voice Handicap Index (VHI-30) will be subtracted from 12-week post-operative total score. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07894172
GET https://conductscience.org/api/trials/v1/NCT07894172/registered