Last reviewed · How we verify
NCT04934176
3D Dynamic and Patient-Centered Outcomes of Facial Reanimation Surgery in Patients With Facial Paralysis
trial testing Psychosocial scales/questionnaires in Facial Paralysis in 125 participants. Currently enrolling.
3 January 2026
Quick facts
| Lead sponsor | Tufts University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 125 |
| Start date | 3 June 2021 |
| Primary completion | 3 January 2026 |
| Estimated completion | 3 June 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Psychosocial scales/questionnaires
- 3D Facial Measurements
Conditions studied
- Facial Paralysis — all drugs for Facial Paralysis →
Sponsor
Tufts University
Who can join
Adults 18 to 75, any sex, with Facial Paralysis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this study, patients who have undergone facial paralysis surgery will be asked to participate. The goal of this study is to compare the facial disability and perception outcomes of facial reanimation surgeries in patients with extensive and permanent, unilateral paralysis using 3D analysis, and compare patient-centered outcomes of facial appearance, well-being, and satisfaction using validated questionnaires. The focus point of this study will be on outcomes of mid-facial reanimation surgeries in patients with more extensive and permanent, unilateral, paralysis of varied etiology and presentation. The specific aims of the study are as follows. Specific Aim 1. To quantitatively determine the surgical effects/impact on facial disability (facial impairment and disfigurement) among four surgically treated groups of patients with unilateral facial paralysis who undergo free gracilis muscle transfer driven by (1) a trigeminal nerve (nV) graft, (2) a crossface nerve graft (nVII), (3) dual innervation comprising both nerves, and (4) midfacial modification. 1. We will compare the changes in facial disability among the groups before and after surgery, and the differences in facial disability between each surgery group and the controls before and after surgery. 2. Specific Aim 2. To compare among the surgery groups the changes in self-perceptions of facial appearance and well-being that occur due to facial reanimation surgery, and to compare the surgery groups before and at 18 months to historical controls recruited during the tenure of the R21 grant. 3. Specific Aim 3. In patients with facial paralysis, to compare surgeons' current qualitative assessment and 2D, quantitative assessment of facial impairment and disfigurement with the objective, 3D, quantitative assessments in order to determine the clinical utility of the 3D assessment approach as an outcome measure and relevance for dissemination to the surgical community.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04934176
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Facial Paralysis
Currently open trials in the same condition.
- NCT07436624 — Kabat Rehabilitation Versus Kinesiology Taping in Bell's Palsy · NA · active not recruiting
- NCT06335719 — Intraoperative Electrical Stimulation to Improve Nerve Grafting Outcome · NA · recruiting
Other Tufts University trials
Trials by the same sponsor.
- NCT07249242 — Healing Outcomes of Peri-implant Soft Tissues With Different Healing Abutments · NA · recruiting
- NCT07099131 — Effective Interventions to Overcome Severe Gag Reflex · EARLY_PHASE1 · not yet recruiting
- NCT06428630 — Systemic Absorption of Dexamethasone Oral Rinse in Patients With Oral Lichen Planus · EARLY_PHASE1 · withdrawn
- NCT06526221 — Evaluating Urine Isoniazid Testing to Detect Nonadherence to Tuberculosis Medications in India · NA · not yet recruiting
- NCT06352645 — Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04934176 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tufts University
- Last refreshed: 27 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04934176.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing