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Completed

NCT Number: NCT02400008

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

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.

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Key information

Conditions

Bilateral Vocal Fold Paralysis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rouen University Hospital

Rouen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery for bilateral laryngeal reinnervation

Procedure

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

Primary outcomes

  1. Maximal phonation time

    Time frame: 18 Months

    Maximal phonation time will be assessed at 18 Months

Secondary outcomes

  1. Voice quality assessed using quality of life questionnaire

    Time frame: 18 Months

    Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores

  2. Voice quality assessed using computerized analysis

    Time frame: 18 Months

    Voice quality will be assessed using computerized analysis

  3. Voice quality assessed using swallowing scores

    Time frame: 18 Months

    Voice quality will be assessed using swallowing scores

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Acronym: SEQLAR

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Mar 26, 2015
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.