Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis
Primary Purpose
Presbylarynx, Atrophy; Larynx, Dysphonia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serial PRP injections
Sponsored by
About this trial
This is an interventional treatment trial for Presbylarynx focused on measuring presbyphonia, presbylarynx, vocal fold atrophy, dysphonia, platelet rich plasma, PRP, vocal fold scar
Eligibility Criteria
Inclusion Criteria:
- Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist
- Patients with a pre-injection VHI-10 score of ≥ 10
- Willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure
- Ability to give informed consent
Exclusion Criteria:
- Other co-existing laryngeal pathology that would affect either the safety or potential benefit from PRP injection
- Current smoker
- Underlying coagulopathy, thrombocytopenia, or platelet dysfunction
Sites / Locations
- University of Southern California
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Serial PRP injections
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT03749863
First Posted
September 29, 2018
Last Updated
May 8, 2023
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT03749863
Brief Title
Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis
Official Title
Safety and Efficacy of Serial Platelet-Rich Plasma Injections for Treatment of Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Presbylarynx, Atrophy; Larynx, Dysphonia, Vocal Cord Atrophy, Presbylarynges, Vocal Fold Scar, Sulcus Vocalis of Vocal Cord
Keywords
presbyphonia, presbylarynx, vocal fold atrophy, dysphonia, platelet rich plasma, PRP, vocal fold scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Serial monthly vocal fold injections with PRP for total of 4 injections.
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Serial PRP injections
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Serial PRP injections
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale
Description
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
Secondary Outcome Measure Information:
Title
Voice-Related Quality of Life as assessed by Voice Handicap Index-10 (VHI-10) and Vocal Fatigue Index (VFI)
Description
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
Title
Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument
Description
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
Title
Vocal Fold Appearance as assessed by experts using a modified version of the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Vocal fold atrophy, scar, and/or sulcus vocalis diagnosed on laryngeal video stroboscopy by a fellowship-trained laryngologist
Patients with a pre-injection VHI-10 score of ≥ 10
Willingness to follow study requirements and perform follow-up visits for up to 4 months following the procedure
Ability to give informed consent
Exclusion Criteria:
Other co-existing laryngeal pathology that would affect either the safety or potential benefit from PRP injection
Current smoker
Underlying coagulopathy, thrombocytopenia, or platelet dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Johns, MD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25132245
Citation
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.
Results Reference
background
PubMed Identifier
29799925
Citation
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.
Results Reference
background
PubMed Identifier
26292799
Citation
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.
Results Reference
background
PubMed Identifier
24587881
Citation
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.
Results Reference
background
PubMed Identifier
29988271
Citation
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.
Results Reference
background
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Serial Platelet-Rich Plasma Injections for Vocal Fold Atrophy, Scar, and/or Sulcus Vocalis
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