Electromyography-Guidance for Chemodenervation in Facial Synkinesis
NCT07931157, Phase 4, Completed, Vanderbilt University Medical Center
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Electromyography-Guidance for Chemodenervation in Facial Synkinesis | ClinicalTrials.gov |
| NCT number | NCT07931157 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 38 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Vanderbilt University Medical Center | ClinicalTrials.gov |
| Conditions | Facial Synkinesis | ClinicalTrials.gov |
| Interventions | Botulinium Toxin-A, Electromyography-guided injection, Non-Electromyography-guided injection | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in Synkinesis Assessment Questionnaire (SAQ) score | Pre-injection and 3 weeks post-injection in each treatment period (crossover at 3 months) | The SAQ is a validated 9-item patient-reported measure of synkinesis-related symptoms, scored 0-100. Higher scores indicate greater synkinesis severity. Change from pre-injection to 3 weeks post-injection is compared between the electromyography (EMG)-guided and non-EMG-guided treatment periods. | ClinicalTrials.gov |
| Primary | Change in Facial Clinimetric Evaluation (FaCE) score | Pre-injection and 3 weeks post-injection in each treatment period | The FaCE is a validated 15-item patient-reported instrument covering facial movement, facial comfort, oral function, eye comfort, lacrimal control, and social function. It is scored 0-100, and lower scores indicate greater disability. Change from pre-injection to 3 weeks post-injection is compared between treatment periods. | ClinicalTrials.gov |
| Secondary | Change in Sunnybrook Facial Grading System (SFGS) composite score | Pre-injection and 3 weeks post-injection in each treatment period | Standardized photographs were taken at rest and during forehead wrinkle, gentle eye closure, open-mouth smile, lip pucker, and snarl. They were graded by two independent physicians who were blinded to injection condition and to each other's scores, and who did not grade their own patients. The composite score ranges 0-100, and higher scores indicate better facial function. Change from pre-injection to 3 weeks post-injection is compared between treatment periods. | ClinicalTrials.gov |
| Other | Procedural Pain Score Measured Using a Non-Standardized 10-Point Numerical Rating Scale | Immediately after injection | Procedural pain was assessed immediately following each injection session using a non-standardized patient-reported numerical rating scale ranging from 1 to 10. Higher scores indicated greater pain during the injection procedure. Scores were compared between electromyography-guided and non-electromyography-guided treatment periods. | ClinicalTrials.gov |
| Other | Procedural Anxiety Score Measured Using a Non-Standardized 10-Point Numerical Rating Scale | Immediately after injection | Procedural anxiety was assessed immediately following each injection session using a non-standardized patient-reported numerical rating scale ranging from 1 to 10. Higher scores indicated greater anxiety experienced during the injection procedure. Scores were compared between electromyography-guided and non-electromyography-guided treatment periods. | ClinicalTrials.gov |
| Other | Patient Confidence in Provider Muscle Targeting Measured Using a Non-Standardized 10-Point Numerical Rating Scale | Immediately after injection in each treatment period | Patient confidence in the treating provider's ability to accurately target the intended facial muscle groups was assessed immediately following each injection session using a non-standardized patient-reported numerical rating scale ranging from 1 to 10. Higher scores indicated greater confidence in provider muscle-targeting accuracy. Scores were compared between electromyography-guided and non-electromyography-guided treatment periods. | ClinicalTrials.gov |
| Other | Perceived Importance of Electromyography Guidance Measured Using a Non-Standardized 10-Point Numerical Rating Scale | Immediately after injection | The perceived importance of electromyography guidance during botulinum toxin injections was assessed immediately following each injection session using a non-standardized patient-reported numerical rating scale ranging from 1 to 10. Higher scores indicated greater perceived importance of electromyography guidance. Scores were compared between electromyography-guided and non-electromyography-guided treatment periods. | ClinicalTrials.gov |
| Other | Patient Injection Technique Preference Assessed Using a Non-Standardized Post-Injection Preference Survey | Immediately after injection | Patient preference for electromyography-guided versus non-electromyography-guided botulinum toxin injections was assessed using a non-standardized patient-reported preference survey. Responses were categorized as preference for electromyography-guided injections, preference for non-electromyography-guided injections, or no preference. The proportion of participants selecting each response category was evaluated. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 16
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 10765054 | BACKGROUND | PubMed |
| 11224766 | BACKGROUND | PubMed |
| 18347234 | BACKGROUND | PubMed |
| 20351606 | BACKGROUND | PubMed |
| 23683725 | BACKGROUND | PubMed |
| 25320703 | BACKGROUND | PubMed |
| 26595022 | BACKGROUND | PubMed |
| 27930763 | BACKGROUND | PubMed |
| 28389084 | BACKGROUND | PubMed |
| 30828959 | BACKGROUND | PubMed |
| 31232802 | BACKGROUND | PubMed |
| 32700008 | BACKGROUND | PubMed |
| 33729598 | BACKGROUND | PubMed |
| 34233854 | BACKGROUND | PubMed |
| 36544062 | BACKGROUND | PubMed |
| 37253169 | BACKGROUND | PubMed |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.3.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 4a570df2e7274cee2d4fa2959402fab41880e2cd412e4b590390035fbea69391 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
Release trials-2026-11-12-0.3.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.