Nerve Transfer Techniques for Facial Palsy

Overseen By Z-Hye Lee, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how surgeries, specifically nerve transfer techniques, can improve life quality for people with facial paralysis. It examines the impact of these surgeries on daily living and emotions by comparing outcomes in two groups: those undergoing the surgery and those who had past facial surgeries. Suitable candidates for this trial include individuals planning to have facial nerve transfer surgery or those who had a facial surgery affecting the nerve within the last five years. As an unphased trial, this study allows participants to contribute to pioneering research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these nerve transfer techniques are safe for treating facial paralysis?

Research has shown that nerve transfer techniques can greatly improve facial function for people with facial paralysis. These procedures enhance facial movement and balance. Some studies mention increased synkinesis, or unwanted muscle movement, but overall, the results remain positive.

Patients generally tolerate these techniques well. They are often chosen for their ability to effectively reroute nerves and restore facial movement. While these procedures have been applied in various ways, they consistently prove safe, with few side effects reported in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about nerve transfer techniques for facial palsy because these methods offer a novel way to restore movement and function in facial muscles. Unlike traditional treatments like physical therapy or static surgical solutions, nerve transfers involve redirecting a healthy nerve to reanimate the paralyzed facial muscles, potentially leading to more dynamic and natural facial expressions. This approach aims to improve the quality of life and emotional well-being for individuals affected by facial palsy by offering a more effective and lasting solution. Additionally, by targeting specific nerves, this technique could provide more precise and tailored outcomes compared to existing options.

What evidence suggests that nerve transfer techniques are effective for facial palsy?

Research has shown that nerve transfer techniques can improve facial movement in people with facial paralysis. Studies have found that these techniques significantly enhance facial function, allowing for better expressions. In this trial, participants will join different treatment arms. One arm involves surgery using nerve transfer techniques, which previous studies have shown can improve facial movement in many areas, though it may also increase involuntary muscle movements, known as synkinesis. Another study found that some nerve transfers could lead to faster recovery, but they might also have more side effects. Overall, nerve transfer surgeries offer promising options for restoring facial function in those with facial paralysis. ^{1 2 6 7 8}

Who Is on the Research Team?

Z-Hye Lee, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with facial paralysis due to Bell's Palsy or cancer in the head and neck area. Participants should be those who have not seen improvement with standard treatments and are seeking surgical options to improve their facial function.

Inclusion Criteria

For intervention group: Provision of signed and dated informed consent form

I am scheduled for a facial nerve transfer surgery.

For non-intervention historical control group: Provision of signed and dated informed consent form

Exclusion Criteria

Patients known to be pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo facial nerve transfer techniques to improve facial function and quality of life

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for changes in quality of life and facial function using validated questionnaires at 6, 12, and 18 months post-operatively

18 months

3 visits (in-person)

Safety Monitoring

Monitoring for safety and adverse events throughout the study duration

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Nerve Transfer Techniques

Trial Overview The study focuses on nerve transfer techniques as a surgical intervention to treat facial paralysis. It aims to assess how these surgeries can enhance patients' quality of life by restoring some degree of facial movement.

How Is the Trial Designed?

Group I: Surgery Experimental Treatment 1 Intervention

Group II: Control Experimental Treatment 1 Intervention

Participants will be identified and recruited during their visit to the Center of Reconstructive Surgery.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 7 patients with complete facial nerve paralysis, those who received masseter-to-facial nerve transfers within 6 months of denervation showed significantly better outcomes in mouth movement (11.1 mm vs. 6.5 mm) compared to those who had the procedure after 6 months.

Transferring the masseter nerve to the main facial nerve trunk resulted in a greater improvement in facial symmetry (31.6% improvement) compared to selective transfers, suggesting that the timing and technique of nerve transfer are crucial for optimal recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Masseter to Facial Nerve Transfer May Improve Smile Excursion in Facial Paralysis. Zhang, S., Hembd, A., Ching, CW., et al.[2022]

Facial reanimation surgery significantly improves facial function in patients with iatrogenic facial palsy, as evidenced by reduced lagophthalmos and improved mouth function after the procedure.

The study analyzed 128 patients, revealing that the duration of facial palsy (averaging 7.8 years) negatively correlates with postoperative smiling function, highlighting the importance of early referral to a facial nerve center for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional results after facial reanimation in iatrogenic facial palsy. Györi, E., Mayrhofer, M., Schwaiger, BM., et al.[2021]

Cross-face nerve grafting has shown promising results in reanimating the paralyzed side of the face in patients with facial paralysis, with 8 out of 10 cases achieving good or satisfactory outcomes after surgery.

The overall success of this technique suggests it should be the first approach in treating facial palsy, while other methods should be considered only if further improvement is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-face nerve grafting in facial paralysis. Monballiu, G.[2004]

Cross face nerve transplantation is a two-stage surgical technique for treating facial palsy, showing superior outcomes compared to other substitution methods, especially in cases of nerve regeneration.

In a review of 35 patients, while this technique does not achieve the same quality of recovery as direct repair of the ipsilateral facial nerve, it is recommended for patients under 50 years old, as older patients may benefit more from simpler procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cross-face nerve transplantation in facial palsy. Anderl, H.[2004]

Nerve transfer (NT) and free gracilis muscle transfer (FGMT) significantly improved smile excursion and facial symmetry in patients with facial paralysis, with NT showing a notable increase in oral commissure excursion from 0.4 mm to 2.9 mm (P=0.05).

Quality of life, as measured by the Facial Clinimetric Evaluation (FaCE) Scale, improved significantly in patients who underwent NT (P<0.001), indicating that these surgical interventions not only enhance physical outcomes but also positively impact patients' overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Outcomes in an Emerging Facial Nerve Center: The Oregon Health and Science University (OHSU) Experience. Krane, NA., Chen, JS., Hanseler, H., et al.[2022]

In a study of 46 patients with complete unilateral facial paralysis, both hemihypoglossal transposition with a nerve graft and direct masseteric-facial coaptation effectively reanimated facial movement, but the masseteric technique showed better symmetry and faster onset of movement (62 days vs. 136 days).

The masseteric-facial coaptation technique also avoids the additional surgical risks associated with harvesting a nerve graft, making it a safer option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of hemihypoglossal nerve versus masseteric nerve transpositions in the rehabilitation of short-term facial paralysis using the Facial Clima evaluating system. Hontanilla, B., Marré, D.[2022]

Hypoglossal nerve transfer resulted in better oral commissure symmetry at rest compared to masseteric transfer, indicating a potential advantage in facial appearance after surgery.

Masseteric nerve transfer led to faster reinnervation and better overall facial function as measured by the Sunnybrook Facial Nerve Grading Scale, suggesting it may be more effective for quicker recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglossal and Masseteric Nerve Transfer for Facial Reanimation: A Systematic Review and Meta-Analysis. Urban, MJ., Eggerstedt, M., Varelas, E., et al.[2022]

In a study of seven patients with facial paralysis after skull base surgery, masseteric nerve transfer combined with cross-facial nerve grafting successfully reanimated the midface in all but one patient, with facial motion developing on average 4 months post-surgery.

The procedure resulted in negligible donor site morbidity, as none of the patients experienced impaired chewing function or visible wasting of the masseter muscle, indicating it is a safe and effective option for facial reanimation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Masseteric nerve transfer for short-term facial paralysis following skull base surgery. Yoshioka, N., Tominaga, S.[2015]

Masseteric nerve transfers are effective in restoring significant movement in patients with facial paralysis, although the quality of tone may be poor.

The hypoglossal to facial nerve transfer is a reliable method that improves facial tone and has been enhanced with a transposition technique, resulting in good outcomes with minimal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facial reanimation: an update on nerve transfers in facial paralysis. Jandali, D., Revenaugh, PC.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39970747/

Functional outcomes of dual nerve transfer in patients with ... Dual nerve transfers show statistically and clinically significant improvements in all eFACE domains except for an increase in synkinesis.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1748681525005194

Comparison of Hypoglossal Nerve Transfer and ... Both HNT and HJG are effective for facial reanimation. HNT (ETE) offers faster recovery but has higher morbidity, while HJG minimizes ...

3. frontiersin.org frontiersin.org/journals/surgery/articles/10.3389/fsurg.2024.1440953/full

Facial nerve reconstruction for flaccid facial paralysis A direct facial nerve reconstruction achieved good results in 42.67% of the patients (CI: 26.05%–61.12%). A facial nerve reconstruction with an ...

4. medicaljournalssweden.se medicaljournalssweden.se/JPHS/article/view/6527/22221

Triple nerve transfers for the management of early ... The mean time from palsy onset to surgery was 5.5 ± 2.8 months. Patients showed improvement in static (70.8 ± 21.9 vs. 84.15 ± 6.68, p = 0.002) ...

5. thejns.org thejns.org/focus/view/journals/neurosurg-focus/58/4/article-pE3.xml

Nerve transfers for facial palsy: grading of volitional control ... Nerve transfers are utilized to restore function in cases of facial palsy when the proximal nerve stump is not available for reconstruction.

6. researchprotocols.org researchprotocols.org/2025/1/e64009

Single-Stage Versus 2-Stage Facial Reanimation With a ... This study will explore how the outcomes of single-stage facial reanimation with a free functional muscle flap compare against those of 2-stage ...

7. jprasurg.com jprasurg.com/article/S1748-6815(25)00084-1/abstract

Functional outcomes of dual nerve transfer in patients with ... Retrospective data of 8 patients with facial paralysis who underwent dual nerve transfers at a single tertiary center between 2018 and 2021 were analyzed. Pre- ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36978256/

Outcomes of immediate facial nerve reanimation with ... Facial reanimation using multiple nerve transfers is effective in achieving improvements in facial function and symmetry.