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Search / Trial NCT05191719

Neurotomy to Treat Synkinesis Following Peripheral Facial Palsy

Launched by REBECKA OHM · Jan 3, 2022

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option called neurotomy for people who experience severe synkinesis after having facial paralysis, which often occurs in conditions like Bell's palsy. Synkinesis is when the muscles in the face move together in ways that aren't normal, leading to difficulties in facial expressions. The trial aims to see if neurotomy can be a better alternative to Botox injections for managing these symptoms.

To participate, individuals should be experiencing synkinesis for at least two years and have had Botox injections at least three times a year without satisfactory results. The trial is open to adults aged 18 to 75, and both men and women can join. Participants will need to sign a consent form and should be in generally good health, meaning they do not have serious health issues like uncontrolled diabetes or high blood pressure. If you decide to take part, you will receive treatment and be monitored throughout the study to understand how well this new approach works for managing facial movement and improving quality of life.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Synkinesis following peripheral facial palsy
  • Sunnybrook score \<61
  • Botox injections at least 3 times a year
  • Have received at least 3 Botox injections
  • Botox injections not satisfying treatment
  • Read and signed written consent
  • Exclusion Criteria:
  • Synkinesis since less than 2 years
  • Contractures in facial muscles
  • Other planned surgery in the face during study period
  • Smoking
  • Uncontrolled hypertension
  • Diabetes mellitus
  • Pregnancy or breast feeding
  • Severe systemic disease (ASA 3-4)

About Rebecka Ohm

Rebecka Ohm is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on enhancing patient outcomes, the organization specializes in the design, management, and execution of clinical trials across various therapeutic areas. Utilizing a robust network of experienced professionals and state-of-the-art methodologies, Rebecka Ohm ensures compliance with regulatory standards while prioritizing patient safety and data integrity. The sponsor is driven by a mission to facilitate the development of groundbreaking therapies that address unmet medical needs, fostering collaboration between researchers, healthcare providers, and the pharmaceutical industry.

Locations

Stockholm, , Sweden

Patients applied

0 patients applied

Trial Officials

Birgit Stark, MD, PhD

Principal Investigator

Karolinska Institute/Karolinska University Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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