Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, non-randomized, two-arm comparative clinical trial evaluating outcomes of false vocal fold (FVF) botulinum toxin injections versus standard EMG-guided botulinum toxin injections in patients with essential voice tremor. Participants will receive either FVF injections or EMG-guided injections based on shared clinical decision-making between the treating laryngologist and patient. The study will assess changes in voice-related quality of life, tremor severity, and patient satisfaction over a 12-week follow-up period and compare these outcomes between the two treatment approaches.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving False Vocal Fold (FVF) Injection | Active Comparator | Participants receive endoscopic-guided Onabotulinum toxin A injections to false vocal folds. Dosing and laterality (unilateral vs bilateral) will follow routine clinical practice guided by shared decision making with patient, laryngologist and speech pathologist. |
|
| Participants Receiving Electromyography (EMG)-Guided Injection | Active Comparator | Participants receive Electromyography (EMG)-guided botulinum toxin A injections into the TA/LCA muscles or equivalent targets per standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| False Vocal Fold (FVF) botulinum toxin injections | Procedure | False vocal fold (FVF) injection, or supraglottic injection, is a specialized treatment primarily using Botox to treat severe Adductor Spasmodic Dysphonia (ADSD). It involves injecting botulinum toxin into the false cords to reduce involuntary squeezing (hyperadduction), offering a potential alternative or supplement to traditional true vocal fold injections to minimize breathiness while improving voice quality. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Voice Handicap Index-10 (VHI-10) | To compare the change in Voice Handicap Index-10 (VHI-10) scores from baseline to 4 weeks between patients receiving FVF botulinum toxin injections and those receiving standard EMG-guided botulinum toxin injections. | Baseline, 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| WayAnne Watson, MD | Contact | 205-801-7801 | wayannewatson@gmail.com | |
| Mollie Perryman, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Blake Simpson, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26467807 | Background | Simpson CB, Lee CT, Hatcher JL, Michalek J. Botulinum toxin treatment of false vocal folds in adductor spasmodic dysphonia: Functional outcomes. Laryngoscope. 2016 Jan;126(1):118-21. doi: 10.1002/lary.25515. Epub 2015 Oct 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Electromyography (EMG)-Guided Injection | Procedure | EMG-guided injection is a precise medical technique using electromyography (EMG) to locate specific muscles for botulinum toxin (Botox/Dysport) injections. It uses auditory and visual signals to confirm needle placement in active muscles, enhancing accuracy for treating spasticity, dystonia, and laryngological conditions. |
|