Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis

Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02400008

Acronym

SEQLAR

Enrollment

Registered

2015-03-26

Start date

2014-11-09

Completion date

2021-10-15

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bilateral Vocal Fold Paralysis

Brief summary

Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis. The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides. Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol). Improvement is expected in voice and breathing, without aspiration.

Interventions

PROCEDURESurgery for bilateral laryngeal reinnervation

Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patient with Bilateral vocal fold paralysis in a closure position 6 months to 36 months before. * Patient who has been treated by endoscopic treatment without satisfying result (voice or breathing). * Patient with passive mobile arytenoid at least on one side * Tracheostomized or not * Age \> 18 years old * Good general situation

Exclusion criteria

* Long term vocal fold paralysis (more than 3 years with strong denervation) * Ary-cricoid ankylosis or synechiae * Age \>75 years * Anaesthesiologist contra indication * Strong respiratory disease history * Severe coagulation troubles * Ongoing neoplasia disease * Cardiac pace maker * Pregnant woman or without contraception * Impairment of the freedom

Design outcomes

Primary

Measure	Time frame	Description
Maximal phonation time	18 Months	Maximal phonation time will be assessed at 18 Months

Secondary

Measure	Time frame	Description
Voice quality assessed using quality of life questionnaire	18 Months	Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores
Voice quality assessed using computerized analysis	18 Months	Voice quality will be assessed using computerized analysis
Voice quality assessed using swallowing scores	18 Months	Voice quality will be assessed using swallowing scores

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean-Paul MARIE, Pr

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026