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This study will investigate the safety and efficacy of four serial monthly vocal fold injections of platelet-rich plasma to treat dysphonia secondary to vocal fold atrophy, scar, and/or sulcus vocalis with glottal insufficiency
Vocal fold atrophy, scar, sulcus vocalis, glottal insufficiency with resulting dysphonia is a condition affecting millions of aging Americans, up to 35% of those 65 or older. Currently used treatment methods include voice therapy, injections of inert fillers, and laryngeal framework surgery. These modalities are imperfect with voice therapy requiring considerable time commitment, filler injections generally temporary in benefit, and surgery with increased risks. The investigators intend to conduct a single-arm study to assess the safety and efficacy of autologous platelet-rich plasma (PRP) injection for vocal fold atrophy, sulcus vocalis and scar. PRP is a substance purified from the patient's own blood that consists of platelets, growth factors, and other regenerative molecules that have been shown to promote rejuvenation in a variety of tissue types. Patients with vocal fold atrophy, sulcus vocalis, and scar identified in the USC Voice Center will be offered participation in a study to receive serial PRP injections in one vocal fold. Outcome measures evaluated pre- and post-injection and over follow-up visits will include various patient reported quality of life indices, objective clinical assessments of voice, and laryngeal videostroboscopy examinations. The investigators hypothesize that serial PRP injections will significantly improve vocal fold mucosal volume, morphology, and dysphonia in these patients with no adverse side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Serial PRP injections | Experimental | This arm will receive experimental intervention of serial monthly platelet-rich plasma (PRP) injections to a unilateral vocal fold mucosa for a total of 4 injections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serial PRP injections | Procedure | Autologous platelet-rich plasma will be injected into the vocal fold mucosa in a serial fashion, once per month for a total of 4 injections. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale | Adverse event severity grading scale from 1 to 4, with grade 1 as mild, grade 2 as moderate, grade 3 as severe, and grade 4 potentially life-threatening | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Voice-Related Quality of Life as assessed by Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI) | VHI-10 is a patient questionnaire with 10 statements rated from 0 to 4 with overall scale 0-40; VFI is a patient questionnaire with 19 statements rated from 0-4 with overall scale 0-76. | 4 months |
| Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Johns, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25132245 | Background | Bradley JP, Hapner E, Johns MM 3rd. What is the optimal treatment for presbyphonia? Laryngoscope. 2014 Nov;124(11):2439-40. doi: 10.1002/lary.24642. Epub 2014 Aug 5. No abstract available. | |
| 29799925 | Background | Crawley BK, Dehom S, Thiel C, Yang J, Cragoe A, Mousselli I, Krishna P, Murry T. Assessment of Clinical and Social Characteristics That Distinguish Presbylaryngis From Pathologic Presbyphonia in Elderly Individuals. JAMA Otolaryngol Head Neck Surg. 2018 Jul 1;144(7):566-571. doi: 10.1001/jamaoto.2018.0409. |
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Serial monthly vocal fold injections with PRP for total of 4 injections.
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Blinded evaluations of audio voice recordings will be performed by laryngologists and speech-language pathologists using the CAPE-V, which grades overall severity, roughness, breathiness, strain, pitch, and loudness from 0-100. |
| 4 months |
| Vocal Fold Appearance as assessed by experts using a modified version of the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form | Blinded assessments of recorded laryngeal videostroboscopy exams will be performed by laryngologists and speech-language pathologists using a modified version of the VALI, which is a graphical rating form to grade various components seen on stroboscopy. | 4 months |
| 26292799 | Background | Cobden SB, Ozturk K, Duman S, Esen H, Aktan TM, Avunduk MC, Elsurer C. Treatment of Acute Vocal Fold Injury With Platelet-Rich Plasma. J Voice. 2016 Nov;30(6):731-735. doi: 10.1016/j.jvoice.2015.07.012. Epub 2015 Aug 17. |
| 24587881 | Background | Woo SH, Jeong HS, Kim JP, Koh EH, Lee SU, Jin SM, Kim DH, Sohn JH, Lee SH. Favorable vocal fold wound healing induced by platelet-rich plasma injection. Clin Exp Otorhinolaryngol. 2014 Mar;7(1):47-52. doi: 10.3342/ceo.2014.7.1.47. Epub 2014 Feb 5. |
| 29988271 | Background | Ozgursoy SK, Tunckasik F, Tunckasik ME, Akincioglu E, Dogan H, Beriat GK. Histopathologic Evaluation of Hyaluronic Acid and Plasma-Rich Platelet Injection into Rabbit Vocal Cords: An Experimental Study. Turk Arch Otorhinolaryngol. 2018 Mar;56(1):30-35. doi: 10.5152/tao.2018.2942. Epub 2018 Mar 1. |
| ID | Term |
|---|---|
| D001284 | Atrophy |
| D007818 | Laryngeal Diseases |
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D014832 | Voice Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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