An interventional study of Serial PRP injections in Presbylarynx, Atrophy; Larynx and Dysphonia, sponsored by University of Southern California. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-10.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
132 studies on the registry are indexed under Dysphonia; 38 are open to participants now.
This study's enrollment of 14 is below the median of 30 across 87 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →University of Southern California is the lead sponsor of 791 studies on the registry; 136 are open to participants now.
Of its 70 completed or terminated interventional studies of FDA-regulated products, 32 (46%) have results posted.
Compared within Dysphonia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Atrophy. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Serial PRP injections
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.
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
Time frame: 4 months
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.
Time frame: 4 months
Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument
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.
Time frame: 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.
Time frame: 4 months
Plan to share: No
Ran from Feb 2020 to primary completion in Sep 2022, 31 months.
Of 44 non-industry interventional studies with no phase under Dysphonia, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 47. This study's 31 months is above that.
Counting every sponsor, half of 44 studies reached it within 26 months; a quarter within 11 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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